You should submit comments and suggestions regarding this draft
document within
90
days of publication in the
Federal Register
of the notice announcing the availability of the draft guidance.
Submit written comments to the Division of Dockets Management
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. Identify all comments with the docket number listed in the notice
of availability that publishes in the
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.
For questions regarding this document, contact Bakul Patel at
301-796-5528 or by electronic mail at
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. For questions regarding this document concerning devices
regulated by CBER, contact the Office of Communication, Outreach
and Development (OCOD), by calling 1-800-835-4709 or
301-827-1800.
U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation and Research |
Preface
CDRH
Additional copies are available from the Internet. You may also
send an e-mail request to
dsmica@fda.hhs.gov
to receive an electronic copy of the guidance or send a fax request
to 301-827-8149 to receive a hard copy. Please use the document
number (1741) to identify the guidance you are requesting.
CBER
Additional copies of this draft guidance are available from the
Office of Communication, Outreach and Development (OCOD) (HFM-40),
1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, or by
calling 1-800-835-4709 or 301-827-1800, or from the Internet at
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm
Table of Contents
-
INTRODUCTION -
BACKGROUND -
DEFINITIONS- MOBILE PLATFORM
- MOBILE APPLICATION (MOBILE APP)
- MOBILE MEDICAL APPLICATION (MOBILE MEDICAL APP)
- REGULATED MEDICAL DEVICE
- MOBILE MEDICAL APP MANUFACTURER
-
SCOPE -
REGULATORY APPROACH FOR MOBILE MEDICAL APPS- MOBILE MEDICAL APPS FOR WHICH FDA WILL APPLY REGULATORY
OVERSIGHT
- MOBILE MEDICAL APPS FOR WHICH FDA WILL APPLY REGULATORY
-
REGULATORY REQUIREMENTS- REQUIREMENTS FOR MOBILE MEDICAL DEVICE MANUFACTURERS
SUBJECT TO REGULATORY OVERSIGHT - EXPECTATIONS FOR MOBILE MEDICAL APP DISTRIBUTORS
- REQUIREMENTS FOR MOBILE MEDICAL DEVICE MANUFACTURERS
-
APPENDIX A – EXAMPLES OF MOBILE MEDICAL APPS -
APPENDIX B – EXAMPLES OF CURRENT REGULATIONS -
APPENDIX C – BRIEF DESCRIPTION OF REGULATORY REQUIREMENTS -
APPENDIX D – ADDITIONAL RESOURCES
Draft Guidance for Industry and Food and Drug
Administration Staff
Mobile Medical Applications
This draft guidance when finalized will represent the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. |
I.
Introduction
The Food and Drug Administration (FDA) is issuing this draft
guidance document to inform manufacturers, distributors, and other
entities about how the FDA intends to apply its regulatory
authorities to select software applications intended for use on
mobile platforms (mobile applications or “mobile apps”).
Given the rapid expansion and broad applicability of mobile
apps, the FDA is issuing this draft guidance document to clarify
the types of mobile apps to which the FDA intends to apply its
authority. At this time, the FDA intends to apply its regulatory
requirements solely to a subset of mobile apps that it is calling
mobile medical applications or “mobile medical apps.”
FDA’s guidance documents, including this guidance, do not
establish legally enforceable responsibilities. Instead, guidances
describe the Agency’s current thinking on a topic and should be
viewed only as recommendations, unless specific regulatory or
statutory requirements are cited. The use of the word “should” in
Agency guidances means that something is suggested or recommended,
but not required.
II. FDA Regulation of Research Use Only and Investigational Use
Only IVD products
A growing number of software applications are being developed
for use on mobile platforms, which include smart phones, tablet
computers, and personal digital assistants. As these mobile
platforms become more user friendly, computationally powerful, and
readily available, innovators have begun to develop mobile apps of
increasing complexity to leverage the portability mobile platforms
can offer. Some of these new mobile apps are specifically targeted
to assisting individuals in their own health and wellness
management. Other mobile apps are targeted to healthcare providers
as tools to improve and facilitate the delivery of patient
care.
In 1989, FDA prepared a general policy statement on how it
planned to determine whether a computer-based product and/or
software-based product is a device, and, if so, how the FDA
intended to regulate it. The document, “FDA Policy for the
Regulation of Computer Products, became known as the “Draft
Software Policy.” After 1989, however, the use of computer and
software products as medical devices grew exponentially and the
types of products diversified and grew more complex (and that trend
has continued). As a result, the FDA determined that it would be
impractical to prepare an overarching software policy to address
all of the issues related to the regulation of all medical devices
containing software. Therefore, the Draft Software Policy was
withdrawn.
1
Although the FDA has not issued an overarching software policy,
the Agency has formally classified certain types of software
applications that meet the definition of a device and, through
classification, identified specific regulatory requirements that
apply to these devices and their manufacturers. These software
devices include products that feature one or more software
components, parts, or accessories (such as electrocardiographic
(ECG) systems used to monitor patient activity), as well as devices
that are composed solely of software (such as laboratory
information management systems). On February 15, 2011, the FDA
issued a regulation down-classifying certain computer- or
software-based devices intended to be used for the electronic
transfer, storage, display, and/or format conversion of medical
device data – called Medical Device Data Systems (MDDSs) – from
Class III (high-risk) to Class I (low-risk).
2
Moreover, the FDA has previously clarified that when standalone
software is used to analyze medical device data, it has
traditionally been regulated as an accessory to a medical device
3
or as medical device software.
As is the case with traditional medical devices, mobile medical
apps can pose potential risks to public health. Moreover, mobile
medical apps may pose additional or different risks due to the
unique characteristics of the platform. For example, the
interpretation of radiological images on a mobile device could be
adversely affected by the smaller screen size, lower contrast
ratio, and uncontrolled ambient light of the mobile platform; FDA
intends to take these limitations into account in assessing the
appropriate regulatory oversight for these products.
This guidance clarifies and outlines the FDA’s current thinking.
The Agency will continue to evaluate the potential impact these
technologies might have on improving health care, reducing
potential medical mistakes, and protecting patients.
A. Mobile Platform
For purposes of this guidance, “mobile platforms” are defined as
commercial off-the-shelf (COTS) computing platforms, with or
without wireless connectivity, that are handheld in nature.
Examples of these mobile platforms include mobile computers such as
the iPhone®, BlackBerry® phones, Android® phones, tablet computers,
or other computers that are typically used as smart phones or
personal digital assistants (PDAs).
B. Mobile Application (Mobile App)
For purposes of this guidance, a mobile application or “mobile
app” is defined as a software application that can be executed
(run) on a mobile platform, or a web-based software application
that is tailored to a mobile platform but is executed on a
server.
C. Mobile Medical Application (Mobile Medical App)
For purposes of this guidance, a “mobile medical app” is a
mobile app that meets the definition of “device” in section 201(h)
of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
4
; and either:
- is used as an accessory to a regulated medical device;
or - transforms a mobile platform into a regulated medical
device.
The intended use of a mobile app determines whether it meets the
definition of a “device.” As stated in 21 CFR 801.4,
5
intended use may be shown by labeling
6
claims, advertising materials, or oral or written statements by
manufacturers or their representatives. When the intended use of a
mobile app is for the diagnosis of disease or other conditions, or
the cure, mitigation, treatment, or prevention of disease, or is
intended to affect the structure or any function of the body of
man, the mobile app is a device.
One example is a light emitting diode (LED) included on a mobile
platform with a mobile app to make that LED operate. If the
manufacturer intends the system to illuminate objects generally
(i.e., without a specific device intended use), neither the mobile
app nor the mobile platform would be considered medical devices.
If, however, through marketing and distribution, the mobile app is
promoted by the manufacturer for use as a light source to examine
patients, then the mobile app would meet the definition of a
device. (In this case, the intended use of the light source would
be similar to a conventional device such as an ophthalmoscope.)
In general, if a mobile app is intended for use in performing a
medical device function it is a medical device, regardless of the
platform on which it is run. For example, mobile apps intended to
run on smart phones to analyze glucose meter readings would be
considered similar to software running on a desktop computer, which
is regulated under 21 CFR 862.1345 (“glucose test system”).
D. Regulated Medical Device
For purposes of this guidance, a “regulated medical device” is
defined as a product that meets the definition of “device” in
section 201(h) of the FD&C Act and that has been classified by
the FDA, or otherwise approved or cleared by the FDA review of a
premarket application or other submission for the device. Examples
of such devices are identified in Appendix B.
E. Mobile Medical App Manufacturer
For purposes of this guidance, a “mobile medical app
manufacturer” is defined as any person or entity that manufactures
mobile medical apps in accordance with 21 CFR Parts 803, 806, and
807.
7
This term does not include entities that exclusively distribute
mobile medical apps, without engaging in manufacturing functions;
examples of such distributors may include owners and operators of
“android market”, “iTunes store”, and “BlackBerry App World.” A
mobile medical device manufacturer may include anyone who initiates
specifications, designs, labels, or creates a software system or
application in whole or from multiple software components. Examples
of mobile medical device manufacturers include any person or entity
that:
- Creates, designs, develops, labels, re-labels,
remanufactures, modifies, or creates a software system from
multiple components. This could include a person or entity that
creates a mobile medical app by using commercial off the shelf
(COTS) software components and markets the product to perform as
a mobile medical app; - Provides mobile medical app functionality through a “web
service” or “web support” for use on a mobile platform. For
example, a manufacturer of a mobile medical app that allows users
to access the application’s medical device functionality over the
web is considered a mobile medical app manufacturer; - Initiates specifications or requirements for mobile medical
apps or procures product development/manufacturing services from
other individuals or entities (second party) for subsequent
commercial distribution. For example, when a “developer” (i.e.,
an entity that provides engineering, design, and development
services) creates a mobile medical app from the specifications
that were initiated by the “author,” the “author” who initiated
and developed specifications for the mobile medical app is
considered a “manufacturer” of the mobile medical app under 21
CFR 803.3. For purposes of this guidance, manufacturers of a
mobile medical app would include persons or entities who are the
creators of the original idea (initial specifications) for a
mobile medical app, unless another entity assumes all
responsibility for manufacturing and distributing the mobile
medical app, in which case that other entity would be the
“manufacturer.”
8
Software “developers” of a mobile medical app that are only
responsible for performing design and development activities to
transform the author’s specifications into a mobile medical app
would not constitute manufacturers, and instead the author would
be considered the manufacturer; or - Creates a mobile medical app intended to be used on a mobile
platform, or that manufactures a mobile app to be supported by
hardware attachments to the mobile platform with a device
intended use.
For purposes of this guidance, a mobile platform manufacturer
that commercially markets a mobile platform with an intended use
(as defined in 21 CFR 801.4) of, or to be used with, a device is
considered a device manufacturer under 21 CFR 803, 806 and 807. In
contrast, a mobile platform manufacturer that solely distributes or
markets its platform with no device intended use is considered a
component
9
manufacturer and is exempt from quality systems, registration and
listing requirements as described in those regulations.
10
In other words, the fact that a mobile platform could be used to
run a mobile medical app identified by this guidance does not mean
that the mobile platform manufacturer is considered a medical
device manufacturer. For example, if it is possible to run mobile
medical apps on BrandNamePhone but BrandNamePhone is not marketed
by BrandNameCompany with a medical device intended use, then
BrandNameCompany would not be a medical device manufacturer.
IV. Scope
This guidance explains FDA intentions to apply its regulatory
requirements to a subset of mobile apps. This subset, which we are
calling mobile medical apps as defined in section III, includes
only those that meet the statutory definition of a device; and
either:
- are used as an accessory to a regulated medical device;
or - transform a mobile platform into a regulated medical
device.
This guidance does not specifically address wireless safety
considerations, classification and submission requirements related
to clinical decision support software, or the application of
quality systems to software. The FDA intends to address these
topics through separate guidance(s).
This guidance is limited only to mobile medical apps. The
following examples represent mobile apps that FDA does
not
consider to be mobile medical apps for purposes of this
guidance:
- Mobile apps that are electronic “copies” of medical
textbooks, teaching aids or reference materials, or are solely
used to provide clinicians with training or reinforce training
previously received. These types of apps do not contain any
patient-specific information, but could show examples for a
specific medical specialty. Examples of such medical text books
include the electronic Physician’s Desk Reference and similar
reference materials that are typically used as part of course
instruction and are implemented as electronic books. Exemplary
teaching aids and reference materials include: flash cards or
quizzes that are used for training purposes or as reference
material (e.g., with preloaded medical images, conditions,
pictures, graphs, etc.); slideshows of common conditions; lists
of medical terminology; and review materials that are to be used
by medical students during training. (In contrast, mobile apps
that allow the user to input patient-specific information along
with reference material to automatically diagnose a disease or
condition are considered mobile medical apps). - Mobile apps that are solely used to log, record, track,
evaluate, or make decisions or suggestions related to developing
or maintaining general health and wellness. Such decisions,
suggestions, or recommendations are
notintended for curing, treating, seeking treatment for mitigating,
or diagnosing a specific disease, disorder, patient state, or any
specific, identifiable health condition. Examples of these apps
include dietary tracking logs, appointment reminders, dietary
suggestions based on a calorie counter, posture suggestions,
exercise suggestions, or similar decision tools that generally
relate to a healthy lifestyle and wellness. - Mobile apps that only automate general office operations with
functionalities that include billing, inventory, appointments, or
insurance transactions. Examples include: apps that determine
billing codes like ICD-9 (international statistical
classification of diseases); medical business accounting
functions and aids that track and trend billable hours,
procedures, and reminders for scheduled medical appointments or
blood donation appointments; apps that automate functions such as
collecting patient histories that replace paper-based entry; apps
that enable insurance claims data collection and processing; and
other apps that are similarly administrative in nature. - Mobile apps that are generic aids that assist users but are
not commercially marketed for a specific medical indication.
Examples include apps that use the mobile platform as a
magnifying glass (but
notspecifically for medical purposes),
11
recording audio, note-taking, replaying audio with amplification,
and other similar functionalities. - Mobile apps that perform the functionality of an electronic
health record system or personal health record system.
V. Regulatory approach for mobile medical apps
The FDA recognizes the extensive variety of actual and potential
functions of mobile apps, the rapid pace of innovation in mobile
apps, and potential benefits and risks to public health. Some
manufacturers of mobile medical apps have sought premarket
clearance for their devices; however, many may be unsure about how
the FDA regulations apply to their products.
As described in this guidance, the FDA plans to apply its
regulatory oversight only to certain types of mobile apps.
This narrowly-tailored approach focuses on a subset of mobile
apps that either have traditionally been considered medical devices
or affect the performance or functionality of a currently regulated
medical device. The FDA believes that this subset of mobile apps
poses the same or similar potential risk to the public health as
currently regulated devices if they fail to function as intended.
Using mobile or other innovative platforms along with a mobile
medical app to perform medical device functions does not
necessarily change the intended use or the risk to patients if the
device fails to operate properly.
Although some mobile apps that do not meet the definition of a
mobile medical app may meet the FD&C Act’s definition of a
device, FDA intends to exercise enforcement discretion
12
towards those mobile apps. The FDA intends to monitor the
performance of other
13
mobile apps that are outside this guidance and determine whether
additional or different actions are necessary to protect the public
health. A manufacturer may, however, at its discretion, elect to
register and list, and to seek approval or clearance for these
mobile apps with the FDA.
Nevertheless, the FDA strongly recommends that manufacturers of
all mobile apps that may meet the definition of a device follow the
Quality Systems
14
regulations (which include good manufacturing practices) in the
design and development of their mobile medical apps and initiate
prompt corrections to their mobile medical apps, when appropriate,
to prevent patient and user harm. The FDA has found that the
majority of software-related device failures are due to design
errors. In one study, the most common problem was failure to
validate software prior to routine maintenance.
15
For the subset of mobile medical apps that are subject to
regulatory oversight, manufacturers must meet the requirements
associated with the applicable device classification. If the mobile
medical app, on its own, falls within a medical device
classification, its manufacturer is subject to the requirements
associated with that classification. A mobile medical app, like
other devices, may be classified as class I (general controls),
class II (special controls in addition to general controls), or
class III (premarket approval).
16
The FDA has typically expected that the manufacturer of an
accessory would meet the requirements associated with the
classification of the connected device. However, this approach may
not be well-suited for mobile medical apps that serve as an
accessory to another medical device because of the wide variety of
functions mobile medical apps can potentially perform. Therefore,
FDA is seeking comment on how it should approach mobile medical
apps that are accessories to other medical devices so safety and
effectiveness can be reasonably assured. Mobile medical devices
that are intended to be used as accessories to a regulated medical
device may do so for purposes of (a) displaying, analyzing,
storing, or transmitting patient-specific medical device data, or
(b) controlling the operation, function, or energy source of the
medical device (see Appendix A for examples).
Finally, if the mobile medical app adds medical device
functionality to a mobile platform, the mobile medical app
manufacturer must meet the classification requirements applicable
to that functionality.
A. Mobile medical apps for which FDA will apply regulatory
oversight
Mobile apps may take a number of forms, but it is important to
note that the FDA will apply its regulatory oversight to only the
subset of mobile medical apps as expressed in this guidance.
Similarly, mobile medical apps that transform a mobile platform
into a regulated medical device may do so by using attachments,
display screens, sensors, or other such methods (see Appendix A for
examples).
The following examples represent mobile apps FDA considers
mobile medical apps and that will be subject to its regulatory
oversight:
- Mobile apps that are an extension of one or more medical
device(s) by connecting
17
to such device(s) for purposes of controlling the device(s) or
displaying, storing, analyzing, or transmitting patient-specific
medical device data. Examples of displays of patient-specific
medical device data include remote display of data from bedside
monitors, display of previously stored EEG waveforms, and display
of medical images directly from a Picture Archiving and
Communication System (PACS) server, or similar display functions
that meet the definition of an MDDS. Examples of mobile apps that
control medical devices include apps that provide the ability to
control inflation and deflation of a blood pressure cuff through
a mobile platform and mobile apps that control the delivery of
insulin on an insulin pump by transmitting control signals to the
pumps from the mobile platform. - Mobile apps that transform the mobile platform into a medical
device by using attachments, display screens, or sensors or by
including functionalities similar to those of currently regulated
medical devices. Examples include a mobile app that uses a mobile
platform for medical device functions, such as attachment of a
transducer to a mobile platform to function as a stethoscope,
attachment of a blood glucose strip reader to a mobile platform
to function as a glucose meter, or attachment of
electrocardiograph (ECG) electrodes to a mobile platform to
measure, store, and display ECG signals; or, a mobile app that
uses the built-in accelerometer on a mobile platform to collect
motion information for monitoring sleep apnea. - Mobile apps that allow the user to input patient-specific
information and – using formulae or processing algorithms –
output a patient-specific result, diagnosis, or treatment
recommendation to be used in clinical practice or to assist in
making clinical decisions. Examples include mobile apps that
provide a questionnaire for collecting patient-specific lab
results and compute the prognosis of a particular condition or
disease, perform calculations that result in an index or score,
calculate dosage for a specific medication or radiation
treatment, or provide recommendations that aid a clinician in
making a diagnosis or selecting a specific treatment for a
patient.
To further clarify, the following categories identify the types
of mobile medical apps and their associated classifications.
-
Displaying, storing or transmitting patient-specific
medical device datain its original format –
Mobile medical apps with this functionality constitute an MDDS
(21 CFR 880.6310) and are subject to class I requirements
(general controls), which include adequate design controls,
registration, device listing, adverse event reporting, and
corrections and removals. The FDA believes that requiring general
controls sufficiently manage the risks for mobile medical apps
that are used as a secondary display to a regulated medical
device and are not intended for providing primary diagnosis or
treatment decisions (i.e. mobile medical apps that meet the MDDS
definition). -
Controlling the intended use, function, modes, or energy
source of the connected medical device–
Mobile medical apps of this type are considered an accessory to
the connected device and are required to comply with the controls
applicable to that connected device. The FDA considers such a
mobile medical app to extend the use and functionality of the
connected medical device. As a result, the mobile medical app
would be required to comply with the regulations applicable to
the connected medical device in order to address any associated
risks. -
Transforming or making the mobile platform into a
regulated medical device– Mobile medical devices that use attachments, display screens,
sensors or other such similar components to transform a mobile
platform into a regulated medial device are required to comply
with the device classification associated with the transformed
platform. For example, a mobile medical app that uses sensors
(internal or external) on a mobile platform for electronic
stethoscope functions is considered to convert the mobile
platform into an electronic stethoscope; manufacturers of such a
mobile medical app are required to follow the requirements of 21
CFR 870.1875(b) (Electronic Stethoscope). Similarly, a mobile
medical app that displays radiological images for diagnosis
transforms the mobile platform into a class II PACS under 21 CFR
892.2050. The FDA has already cleared such mobile medical
apps. -
Creating alarms, recommendations or creating new
information (data) by analyzing or interpreting medical device
data– Mobile medical apps of this type that analyze or interpret data
(electronically collected or manually entered) from another
medical device are considered an accessory to that medical
device. These mobile medical apps are generally required to
comply with the device classification associated with that other
medical device. These types of systems have been previously
classified under the same regulations as the connected device;
specifically, the decision support tool is treated as an
accessory and subject to the same regulatory requirements as the
connected device as determined by the connected device’s
classification. For example, software that analyzes blood glucose
readings to help manage diabetes has been classified as part of a
“Glucose Test System” under 21 CFR 862.1345. The FDA has cleared
several mobile medical apps with attachments to a mobile
platform. Examples include patient monitoring mobile apps that
are classified as cardiac monitoring software under 21 CFR
870.2300 (Cardiac monitor). Other mobile medical apps that use a
hardware attachment or interface to a monitoring system that have
been cleared include an automatic electronic blood pressure
monitor (21 CFR 870.1130) and a perinatal monitoring system (21
CFR 884.2740).The FDA plans to address in a separate issuance mobile medical
apps intended to analyze, process, or interpret medical device
data (electronically collected or manually entered) from more
than one medical device. The implications of these analyses and
interpretations may pose a wide range of risks to public health
and patient safety. Requiring such mobile medical apps to comply
with the same requirements as their connected devices may not be
appropriate in some cases. For example, analysis of class I
device information along with other demographic information can
result in an interpretation of a highly acute patient condition,
which presents a greater risk than the connected class I device.
On the other hand, an analysis or interpretation of data from
class II or class III devices can lead to a simple informational
result, with minimal implications or risks to public health and
patient safety-in other words, a level of risk more
characteristic of a class I device. The FDA has previously
classified software that calculates a drug dose based on a
patients height, weight, mass, and other patient-specific
information as a “Drug Dose Calculator” under 21 CFR 868.1890.
The FDA encourages manufacturers of such mobile medical apps to
contact the Agency to determine the classification of their
mobile app. In addition, the FDA seeks public comment on whether
and how it can provide greater clarity for these types of mobile
medical apps.
VI. Regulatory requirements
This guidance, including the Appendix A and existing medical
device regulatory classifications in Appendix B, is intended to
assist manufacturers in determining if a product is a mobile
medical app and FDA’s expectations for that product. Additional
information can be found at:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance
/Overview/ClassifyYourDevice/default.htm
. This section describes in greater detail the regulatory
requirements applicable to mobile medical apps under this guidance
(as described in Section V).
A. Requirements for mobile medical device manufacturers subject
to regulatory oversight
Manufacturers of mobile medical devices are subject to the
requirements described in the applicable device classification
regulations. Depending on the classification and the associated
regulation for the mobile medical device, manufacturers of mobile
medical devices are required to follow associated controls
established by the regulation.
Class I devices: General Controls, including:
- Establishment registration, and Medical Device listing (21
CFR Part 807); - Quality System (QS) regulation (21 CFR Part 820);
- Labeling requirements (21 CFR Part 801);
- Medical Device Reporting (21CFR Part 803);
- Premarket notification (21CFR Part 807);
- Reporting Corrections and Removals (21 CFR Part 806);
and - Investigational Device Exemption (IDE) requirements for
clinical studies of investigational devices (21 CFR Part
812)
Class II devices: General Controls, Special Controls, and (for
most Class II devices) Premarket Notification
Class III devices: General Controls and Premarket Approval (21
CFR Part 814)
Appendix C provides a brief summary of the above requirements.
Additional information is available at
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm
, under “Overview of Medical Device Regulation” and “How to Market
Your Device.”
If you need further assistance, you may contact the Division of
Small Manufacturers, International and Consumer Assistance: Email:
dsmica@fda.hhs.gov
; phone: 301-796-7100 or 800-638-2041.
B. Expectations for mobile medical app distributors
The FDA expects distributors of mobile medical apps who may or
may not be a platform or service provider will cooperate with
manufacturers in conducting corrections and removal actions. Mobile
medical app manufacturers are required to make timely reports of
corrections and removals made to reduce a health risk or remedy a
violation of the FD&C Act that presents a health risk, and to
keep records regarding other corrections and removals.
18
APPENDIX A – Examples of mobile medical apps
This Appendix provides an exemplary list of functionalities to
illustrate types of mobile medical apps. The FDA understands that
there may be other unique and innovative mobile apps that may not
be covered in this list that may also constitute mobile medical
apps. This list is not exhaustive; it is only intended to provide
clarity and assistance in identifying mobile medical apps.
Mobile medical apps that are extensions of regulated medical
device for purposes of controlling the medical device or for the
purpose of displaying, storing, analyzing, or transmitting
patient-specific medical device data:
- Apps that allow the user to view medical images on a mobile
platform and perform an analysis or process for diagnosis; - Apps that connect to DICOM medical image servers and provide
processing functions such as pan, zoom, measurement, auto
contrasting, automatic detection of features, and other similar
functionality; - Apps that analyze, assess, or interpret electrocardiogram or
electroencephalogram data; - Apps that connect the mobile platform to vital signs
monitors, bedside monitors, cardiac monitors, or other similar
devices to:- Be used as a central viewing station for display;
- Remotely access vital sign measurements of patients at
home; - Be used in displaying and viewing digital images, including
digital mammography, for review and analysis by trained medical
practitioners; - Record arterial oxygen saturation and pulse rate of adult
and pediatric patients inside hospitals and activate an alarm
based on changes in levels; - Remotely review other standard or critical real-time
numeric data from labor and delivery; - Perform remote Holter monitoring;
- Connect to medical imaging devices for displaying,
processing or storing medical images; - Wirelessly connect to medical devices and can relay or
generate alarms; - Perform remote control, setting changes, or readout via
wireless links such as programming or controlling a hearing aid
system or implantable or body worn medical device.
- Apps that are used as patient screening tools for blood
transfusion (extension of Blood Establishment Computer Software
(BECS))
or other biologics;
- Apps that connect to a home use diagnostic medical device
such as a blood pressure meter, body composition analyzer, or
blood glucose meter to collect historical data or to receive,
transmit, store, analyze, and display measurements from connected
devices; - Apps that control a blood-pressure cuff connected to a mobile
platform to inflate the cuff and measure a person’s blood
pressure; or - Apps that act as wireless remote controls or synchronization
devices for MRI or X-Ray machines.
Mobile medical apps that transform or make the mobile platform
into a regulated medical device by using attachments or sensors or
similar medical device functions:
- Apps that attach EKG/ECG leads to a mobile platform to
collect/analyze/monitor EKG/ECG signals; - Apps that connect wirelessly to a blood glucose tester to
display, calculate, trend, convert, or download results to a
PDA; - Apps that generate sine signals from 125Hz to 8kHz (8 steps)
to check the user’s hearing; - Apps that act as a blood glucose meter by using an attachment
to a mobile platform; - Apps that act as an electronic stethoscope by connecting
(either via wire or wirelessly) to an external sensor to record,
manipulate, or measure sound waves; - Apps that use the mobile platform with or without a sound
transducer (microphone) to act as an electronic stethoscope to
amplify heart, lung, blood vessel, enteral, and other body
sounds; - Apps that use the built-in accelerometer or other similar
sensors in a mobile platform to monitor the user’s movement to
determine conditions such as sleep apnea, sleep phase, fall
detection, or detect motion related to other conditions or
diseases or to measure heart rate; - Apps that use the light source from a mobile platform to cure
and treat specific conditions, such as acne; - Apps that attach sensors to a mobile platform to measure
blood glucose, electrocardiograph, or other similar
functions; - Apps that use a mobile platform’s built in features such as
light, vibrations, camera, or other similar sources to perform
medical functions; - Apps that use a mobile platform to upload
electroencephalograph (EEG) recordings and automatically detect
seizures; - Apps that use a mobile platform to record response time and
accuracy of patients completing a cognitive task and/or
automatically score or interpret cognitive testing results; - Apps that use pictures and sound to diagnose conditions by
comparing to previously determined diagnoses of images, symptoms,
sounds, or other physiological measurements; or - Apps that use a mobile platform in determining blood donor
eligibility prior to collection of blood or blood
components.
Mobile medical apps that allow the user to input
patient-specific information and
– using formulae or a processing algorithm
– output a
patient-specific
result, diagnosis, or treatment recommendation that is used in
clinical practice or to assist in making clinical decisions:
- Apps that perform calculations intended to be used by
clinicians for automating tasks, such as:- eGFR with CKD-Epi, Cockcroft-Gault, and MDRD;
- A-a gradient, etc.
- Apps that act as calculators or utilize algorithms to produce
an index, score, scale, or other similar calculations (e.g.,
Glasgow Coma Scale, pain index, Apgar score, NIH stroke scale,
etc.); - Apps that calculate parameters associated with the use of
radioisotopes; - Apps that calculate the amount of chemotherapy needed based
on the patient’s Body Surface Area; - Apps that assist with patient-specific dosing, e.g.,
radiation planning; - Apps that calculate Warfarin Loading and Warfarin Maintenance
doses for different anti-coagulation therapies based on
nomograms; - Apps that act as calculators to determine the maximum dosage
of local anesthesia based on a patient’s weight and age; or - Apps that calculate Osteoporosis Risk Assessment by Composite
Linear Estimate (ORACLE score). - Apps that collect blood glucose readings and caloric intake
to help manage diabetes by calculating pre-meal insulin dose
(Bolus) or Basal adjustments; or - Apps that act as a dosing calculators for a treatment regimen
intended for a specific patient population (pediatrics); - Apps that define disease stage or progression, and provide a
prognosis of a medical condition or predict a patient’s response
to treatment based on a analysis of physiological, laboratory,
and other data; or - Apps that provide differential diagnosis tools for a
clinician to systematically compare and contrast clinical
findings (symptoms/ results, etc.) to arrive at possible
diagnosis for a patient.
APPENDIX B – Examples of current regulations
This appendix provides examples of currently regulated devices,
the Class according to which they are regulated, and their
regulation numbers. This list is not a complete list of products
and is intended only to provide clarity and assistance in
identification of applicable regulations. FDA encourages mobile
medical app manufacturers to search FDA’s public databases, such as
the medical device database for premarket cleared (510(k)) devices
and product classification database, to determine the level of
regulation for a given device. The databases can be accessed
through the following link:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/default.htm
.
For more detailed list and a searchable database of medical
device classifications, please visit:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm
.
Additional information can also be found at:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm
.
Regulation number | Medical Device | Device Class | Submission Type ID |
---|---|---|---|
876.1500(b)(2) | Accessories, Photographic, For Endoscope (Exclude Light Sources) |
1 | 510(k) exempt |
870.2770 | Analyzer, Body Composition | 2 | 510(k) |
868.1890 | Calculator, Drug Dose | 2 | 510(k) |
868.1890 | Calculator, Predicted Values, Pulmonary Function |
2 | 510(k) |
868.1880 | Calculator, Pulmonary Function Data | 2 | 510(k) |
868.1900 | Calculator, Pulmonary Function Interpretation (Diagnostic) |
2 | 510(k) |
862.2100 | Calculator/Data Processing Module, For Clinical Use |
1 | 510(k) exempt |
874.3310 | Calibrator, Hearing Aid / Earphone And Analysis Systems |
2 | 510(k) |
878.4160 | Camera, Cine, Microsurgical, With Audio |
1 | 510(k) exempt |
878.4160 | Camera, Still, Microsurgical | 1 | 510(k) exempt |
878.4160 | Camera, Television, Endoscopic, With Audio |
1 | 510(k) exempt |
870.1110 | Computer, Blood-Pressure | 2 | 510(k) |
870.1425 | Computer, Diagnostic, Programmable | 2 | 510(k) |
892.2020 | Device, Communications, Images, Ophthalmic |
1 | 510(k) exempt |
892.2010 | Device, Digital Image Storage, Radiological |
1 | 510(k) exempt |
892.2010 | Device, Storage, Images, Ophthalmic | 1 | 510(k) exempt |
876.1500 | Device, Telemedicine, Robotic | 2 | 510(k) |
862.2100 | Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System |
1 | 510(k) exempt |
892.2030 | Digitizer, Image, Radiological | 2 | 510(k) |
892.2030 | Digitizer, Images, Ophthalmic | 2 | 510(k) |
870.2800 | Electrocardiograph, Ambulatory, With Analysis Algorithm |
2 | 510(k) |
882.1400 | Electroencephalograph – Automatic Event Detection Software For Full-Montage Electroencephalograph |
2 | 510(k) |
882.1400 | Electroencephalograph – Burst Suppression Detection Software For Electroencephalograph |
2 | 510(k) |
882.1400 | Electroencephalograph – Index-Generating Electroencephalograph Software |
2 | 510(k) |
882.1400 | Electroencephalograph – Non-Normalizing Quantitative Electroencephalograph Software |
2 | 510(k) |
882.1400 | Electroencephalograph – Normalizing Quantitative Electroencephalograph Software |
2 | 510(k) |
882.1400 | Electroencephalograph – Source Localization Software For Electroencephalograph Or Magnetoencephalograph |
2 | 510(k) |
876.1500 | Endoscopic Video Imaging System/Component, Gastroenterology-Urology |
2 | 510(k) |
884.2225 | Imager, Ultrasonic Obstetric-Gynecologic |
2 | 510(k) |
876.1500 | Led Light Source | 2 | 510(k) |
878.4810 | Light Based Over The Counter Wrinkle Reduction |
2 | 510(k) |
878.4810 | Light Based Over-The-Counter Hair Removal |
2 | 510(k) |
880.6350 | Light, Examination, Medical, Battery Powered |
1 | 510(k) exempt |
880.5580 | Locator, Acupuncture Point | 2 | 510(k) |
870.1875(b) | Lung Sound Monitor | 2 | 510(k) |
886.5540 | Magnifier, Hand-Held, Low-Vision | 1 | 510(k) exempt |
880.6315 | Medication Management System, Remote | 2 | 510(k) |
884.6190 | Microscope And Microscope Accessories, Reproduction, Assisted |
1 | 510(k) exempt |
868.2377 | Monitor, Apnea, Home Use | 2 | 510(k) |
880.2400 | Monitor, Bed Patient | 1 | 510(k) exempt |
884.2660 | Monitor, Blood-Flow, Ultrasonic | 2 | 510(k) |
868.2375 | Monitor, Breathing Frequency | 2 | 510(k) |
870.2300 | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) |
2 | 510(k) |
886.1510 | Monitor, Eye Movement, Diagnostic | 2 | 510(k) |
884.2660 | Monitor, Fetal Doppler Ultrasound | 2 | 510(k) |
884.2730 | Monitor, Heart Rate, Fetal, Non-Stress Test (Home Use) |
2 | 510(k) |
884.2660 | Monitor, Heart Rate, Fetal, Ultrasonic |
2 | 510(k) |
884.2660 | Monitor, Hemic Sound, Ultrasonic | 2 | 510(k) |
884.2640 | Monitor, Phonocardiographic, Fetal | 2 | 510(k) |
870.2300 | Monitor, Physiological, Patient(Without Arrhythmia Detection Or Alarms) |
2 | 510(k) |
870.2340 | Monitor, St Segment | 2 | 510(k) |
884.2660 | Monitor, Ultrasonic, Fetal | 2 | 510(k) |
884.2720 | Monitor, Uterine Contraction, External (For Use In Clinic) |
2 | 510(k) |
878.4810 | Over-The-Counter Powered Light Based Laser For Acne |
2 | 510(k) |
868.2550 | Pneumotachometer | 2 | 510(k) |
878.4810 | Powered Light Based Non-Laser Surgical Instrument |
2 | 510(k) |
870.2800 | Recorder, Event, Implantable Cardiac,(Without Arrhythmia Detection) |
2 | 510(k) |
876.1725 | Recorder, External, Pressure, Amplifier & Transducer |
2 | 510(k) |
890.5050 | Reminder, Medication | 1 | 510(k) exempt |
880.2700 | Scale, Stand-On, Patient | 1 | 510(k) exempt |
864.9175 | Software, Blood Bank, Stand Alone Products |
2 | 510(k) |
886.5540 | Spectacle Microscope, Low-Vision | 1 | 510(k) exempt |
868.1850 | Spirometer, Monitoring (W/Wo Alarm) | 2 | 510(k) |
870.1875(b) | Stethoscope, Electronic | 2 | 510(k) |
868.1920 | Stethoscope, Esophageal, With Electrical Conductors |
2 | 510(k) |
884.2900 | Stethoscope, Fetal | 1 | 510(k) exempt |
876.4300 | System, Alarm, Electrosurgical | 2 | 510(k) |
884.2990 | System, Documentation, Breast Lesion | 2 | 510(k) |
892.2050 | System, Image Processing, Radiological |
2 | 510(k) |
892.1560 | System, Imaging, Optical Coherence Tomography (Oct) |
2 | 510(k) |
884.2800 | System, Monitoring, For Progress Of Labor |
2 | 510(k) |
884.2740 | System, Monitoring, Perinatal | 2 | 510(k) |
870.2300 | System, Network And Communication, Physiological Monitors |
2 | 510(k) |
876.1500 | System, Surgical, Computer Controlled Instrument |
2 | 510(k) |
864.9175 | System, Test, Automated Blood Grouping And Antibody |
2 | 510(k) |
880.2910 | Thermometer, Electronic, Clinical | 2 | 510(k) |
886.1930 | Tonometer, Ac-Powered | 2 | 510(k) |
870.2920 | Transmitters And Receivers, Electrocardiograph, Telephone |
2 | 510(k) |
870.2910 | Transmitters And Receivers, Physiological Signal, Radiofrequency |
2 | 510(k) |
APPENDIX C – Brief description of regulatory requirements
This Appendix provides a high level description of some select
regulatory requirements for medical devices, including mobile
medical apps. The FDA has additional resources and publications
online that describes the requirements in detail.
1. Establishment Registration and Medical Device Listing
Under 21 CFR Part 807, manufacturers of medical devices are
required to annually register their establishments
19
with FDA and provide a list of the devices they market. The
registration and listing requirement is a means of keeping FDA
advised of who is manufacturing devices, and of the types of
devices an establishment is manufacturing. Mobile medical app
manufacturers are required to register their establishments with
FDA and to list
20
by identifying to FDA the mobile medical apps they are
marketing.
Additional information can be found at:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/default.htm
. If you need further assistance, you may contact the Division of
Risk Management Operations, Regulatory Policy and Systems Branch:
Email:
reglist@fda.hhs.gov
, phone: 301-796-7400. Assistance is also available from, Division
of Small Manufacturers, International and Consumer Assistance:
Email:
dsmica@fda.hhs.gov
phone: 301-796-7100 or 800-638-2041
2. Investigational Device Exemption (IDE) requirements
An IDE allows an investigational device to be used in a clinical
study in order to collect safety and effectiveness data required to
support a Premarket Approval (PMA) application or a Premarket
Notification 510(k) submission to FDA. Clinical studies with
devices of significant risk must be approved by FDA and by an
Institutional Review Board (IRB) before the study can begin.
Studies with devices of non-significant risk must be approved by
the IRB only before the study can begin.
Mobile medical app manufacturers who are creating mobile apps
with novel technologies are encouraged to engage in early
collaboration meetings with the FDA to receive clear direction for
testing and development of those devices requiring clinical
investigations to support marketing.
Additional information about these meetings is described in
guidance issued on February 28, 2001: ”
Early Collaboration Meetings Under the FDA Modernization Act
(FDAMA); Final Guidance for Industry and for CDRH Staff.
“
Further information regarding the investigational device
exemption can be found at:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/default.htm
.
3. Labeling requirements
Medical device manufacturers are required to comply with
applicable labeling regulations found in 21 CFR Part 801, and Part
809 for radiological health products.
4. Premarket submission for approval or clearance
Mobile medical app manufacturers should identify the current
classification covering their mobile medical app. Manufacturers are
required to prepare and submit to the FDA an appropriate premarket
submission, as required for their device classification.
Additional information can be found at:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
HowtoMarketYourDevice/RegistrationandListing/default.htm
.
5. Quality System Regulation (QSR)
Mobile medical app manufacturers are required to comply with the
QSR. The QSR does not prescribe in detail how a manufacturer must
produce a specific device, but provides a framework for all
manufacturers to develop and follow to help ensure that their
products consistently meet applicable requirements and
specifications. As part of this framework, mobile medical app
manufacturers are required to develop requirements for their
products that will result in devices that are safe and effective,
and to establish methods and procedures to design, produce, and
distribute their devices.
Furthermore, mobile medical app manufacturers are required, as
part of the QSR (21 CFR 820.30), to appropriately verify and
validate their mobile medical apps along with the mobile platform
to ensure safe and effective operation of the mobile medical
app.
Mobile medical app manufacturers are required to ensure that
adequate controls and processes are in place through purchasing
controls to ensure safe distribution, installation and operation of
the mobile medical app.
Additional information regarding the QS regulation and can be
found at:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
PostmarketRequirements/QualitySystemsRegulations/default.htm
.
6. Medical Device Reporting (MDR) (Adverse event
reporting)
The Medical Device Reporting (MDR) regulation requires
manufacturers and importers of medical devices to submit reports to
the FDA whenever they receive or otherwise become aware of
information, from any source, that reasonably suggests that a
device they market may have caused or contributed to a death or
serious injury, or has malfunctioned and the device or a similar
device that they market would be likely to cause or contribute to a
reportable death or serious injury if the malfunction were to
recur.
21
MDR requires medical device manufacturers to:
- Submit MDR reportable events involving their medical devices
as described in 21 CFR Parts 803.10(c) and 803.50; - Submit 5-day reports as described in 21 CFR Part 803.53;
- Submit supplemental reports as described in 21 CFR Part
803.56; - Develop, maintain, and implement written procedures for the
identification and evaluation of all medical device events to
determine whether the event is MDR reportable as described in 21
CFR Part 803.17; - Conduct an investigation of each event and evaluate the cause
of the event as described in 21 CFR Part 803.50(b)(3); and - Establish and maintain complete files for all complaints
concerning adverse medical device events as described in 21 CFR
Part 803.18.
The MDR report (FDA Form 3500A) must contain all the information
described in 21 CFR Part 803.52 that is reasonably known to the
manufacturer. Information reasonably known includes any information
that:
- Can be obtained by contacting a user facility, importer, or
other initial reporter; - Is in the possession of the manufacturer; or
- Can be obtained by analysis, testing, or other evaluation of
the device.
For additional instructions on how to complete the 3500A form,
refer to the document titled ”
Instructions for Completing Form FDA 3500A.
“
For additional guidance on the MDR regulation and the reporting
requirements, refer to the document titled ”
Medical Device Reporting for Manufacturers
.”
For Questions about Medical Device Reporting, including
interpretation of MDR policy:
- Call: (301) 796-6670 (voice)
- Email:
RSMB@fda.hhs.gov - Or write to:
- Food and Drug Administration
Center for Devices and Radiological Health
Reporting Systems Monitoring Branch
10903 New Hampshire Avenue
WO Bldg. 66, Room 3217
Silver Spring, MD 20993-0002
- Food and Drug Administration
7. Correcting Problems
A mobile medical app manufacturer may voluntarily take action at
any time or may be requested to take action by the FDA to correct
problems. Voluntary action is usually taken by device
manufacturers. Examples of the types of actions that a mobile
medical app manufacturer may be requested to take include, but are
not limited to:
- Inspecting the device for problems;
- Repairing the device;
- Adjusting settings on the device; and
- Upgrading software to reduce risk from a “bug” or unintended
response.
Under certain circumstances, FDA may initiate a request that a
manufacturer address a problem with a device through other means,
including by removal of the product from the market. When
recommending corrective action, the FDA intends to take into
account the essential role that certain mobile medical apps take as
an integral part of a larger patient care system.
Reporting Corrections to FDA:
In accordance with 21 CFR 806.10, mobile medical app
manufacturers are required to promptly report, within 10 working
days from the time the correction is initiated, to the FDA certain
actions concerning device corrections and removals for the mobile
medical app. Specifically, mobile medical app manufacturers are
required to report to FDA any corrections made to a mobile medical
app to reduce a risk to health posed by the mobile medical app or
to remedy a violation of the FD&C Act caused by the mobile
medical app which may present a risk to health.
The reporting requirement does not extend to all modifications
to mobile medical apps. For example, mobile medical app
manufacturers are exempt from reporting requirements under 21 CFR
806.1(b)
22
for certain actions that would improve the quality of a mobile
medical app but that would not reduce a risk to health posed by the
mobile medical app or remedy a violation of the FD&C Act. If
there is not a “risk to health” involved, a report to FDA is not
required, but the mobile medical app manufacturer must keep a
record of the correction.
More information about reporting requirements under 21 CFR Part
806 is available at:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/RecallsCorrectionsAndRemovals
.
For additional general information about medical device recalls,
visit:
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/default.htm
.
APPENDIX D – Additional Resources
-
Guidance for Industry and FDA Staff – Implementation of Medical
Device Establishment Registration and Device Listing
Requirements Established by the Food and Drug Administration
Amendments Act of 2007 -
Medical Device Reporting for Manufacturers
-
Guidance for the Submission of Premarket Notifications for
Medical Image Management Devices -
Guidance for the Content of Premarket Submissions for Software
Contained in Medical Devices - Devices; Current Good Manufacturing Practice (CGMP) Final
Rule; Quality System Regulation” (61 FR 52602–52662). The
Quality System regulation (Title 21 Code of Federal Regulations
Part 820) -
Design Control Guidance For Medical Device Manufacturers
-
General Principles of Software Validation; Final Guidance for
Industry and FDA Staff -
Guidance for Industry – Cybersecurity for Networked Medical
Devices Containing Off-the-Shelf (OTS) Software—
- Information for Healthcare Organizations about FDA’s ”
Guidance for Industry: Cybersecurity for Networked Medical
Devices Containing Off-The-Shelf (OTS) Software“
- IEC 60601-1-4:1996,
Medical electrical equipment, Part 1: General requirements
for safety, 4. Collateral Standard: Programmable electrical
medical systems. International Electrotechnical Commission, 1996.
- IEC 62304:2006,
Medical device Software – Software life cycle processes. International Electrotechnical Commission, 2006.
- IEC 61508:1998,
Functional safety of electrical/electronic/programmable
electronic safety-related systems.International Electrotechnical Commission, 1998.
- IEEE Std 1012-1986,
Software Verification and Validation Plans, Institute for Electrical and Electronics Engineers, 1986.
-
IEEE Standards Collection, Software Engineering
, Institute of Electrical and Electronics Engineers, Inc., 1994.
ISBN 1-55937-442-X. - ISO 8402:1994,
Quality management and quality assurance – Vocabulary.International Organization for Standardization, 1994.
- ISO 9000-3:1997,
Quality management and quality assurance standards – Part 3:
Guidelines for the application of ISO 9001:1994 to the
development, supply, installation and maintenance of computer
software. International Organization for Standardization, 1997.
- ISO 9001:1994,
Quality systems – Model for quality assurance in design,
development, production, installation, and servicing.International Organization for Standardization, 1994.
- ISO 13485:1996,
Quality systems – Medical devices – Particular requirements
for the application of ISO 9001.International Organization for Standardization, 1996.
- ISO/IEC 12119:1994,
Information technology – Software packages – Quality
requirements and testing,Joint Technical Committee ISO/IEC JTC 1, International
Organization for Standardization and International
Electrotechnical Commission, 1994. - ISO/IEC 12207:1995,
Information technology – Software life cycle processes,Joint Technical Committee ISO/IEC JTC 1, Subcommittee SC 7,
International Organization for Standardization and International
Electrotechnical Commission, 1995. - ISO/IEC 14598:1999,
Information technology – Software product evaluation,Joint Technical Committee ISO/IEC JTC 1, Subcommittee SC 7,
International Organization for Standardization and International
Electrotechnical Commission, 1999. - ISO 14971-1:1998, Medical Devices – Risk Management – Part 1:
Application of Risk Analysis. International Organization for
Standardization, 1998. - The draft guidance ”
Radio-Frequency Wireless Technology in Medical Devices“.
70 FR 824 at 890 (January 5, 2005) Federal Register Notice [Docket
No 1998N-0046],
http://edocket.access.gpo.gov/2005/pdf/05-155.pdf.
76 FR 8637 (Feb. 15, 2011), Final Rule.
See, for example,
Content of a 510(k)
— (“Accessories to classified devices take on the same
classification as the “parent” device. An accessory such as
software that accepts input from multiple devices usually takes on
the classification of the “parent” device with the highest risk,
i.e., class.”); Final Rule, Medical Devices, Medical Device Data
Systems, 76 Fed. Reg. 8637, 8643-8644 (Feb. 15, 2011).
Products that are built with or consist of computer and/or software
components or applications are subject to regulation as devices
when they meet the definition of a device in section 201(h) of the
FD&C Act. That provision defines a device as “…an instrument,
apparatus, implement, machine, contrivance, implant, in vitro
reagent…..”, that is “…intended for use in the diagnosis of disease
or other conditions, or in the cure, mitigation, treatment, or
prevention of disease, in man…” or “…intended to affect the
structure or any function of the body of man or other animals…”
Thus, software applications that run on a desktop computer, laptop
computer, remotely on a website or “cloud,” or on a handheld
computer may be subject to device regulation if they are intended
for use in the diagnosis or the cure, mitigation, treatment, or
prevention of disease, or to affect the structure or any function
of the body of man. The level of regulatory control necessary to
assure safety and effectiveness varies based upon the risk the
device presents to public health. , (See Appendix B for
examples).
“The words ‘intended uses’ or words of similar import … refer to
the objective intent of the persons legally responsible for the
labeling of devices. The intent is determined by such persons’
expressions or may be shown by the circumstances surrounding the
distribution of the article. This objective intent may, for
example, be shown by labeling claims, advertising matter, or oral
or written statements by such persons or their representatives. It
may be shown by the circumstances that the article is, with the
knowledge of such persons or their representatives, offered and
used for a purpose for which it is neither labeled nor advertised.
The intended uses of an article may change after it has been
introduced into interstate commerce by its manufacturer. If, for
example, a packer, distributor, or seller intends an article for
different uses than those intended by the person from whom he
received the devices, such packer, distributor, or seller is
required to supply adequate labeling in accordance with the new
intended uses. But if a manufacturer knows, or has knowledge of
facts that would give him notice that a device introduced into
interstate commerce by him is to be used for conditions, purposes,
or uses other than the ones for which he offers it, he is required
to provide adequate labeling for such a device which accords with
such other uses to which the article is to be put.” 21 CFR
801.4.
“The term ‘labeling’ means all labels and other written, printed,
or graphic matter (1) upon any article or any of its containers or
wrappers, or (2) accompanying such article.” Section 201(m) of the
FD&C Act, 21 U.S.C. § 321(m).
Regulatory definitions of the term “manufacturer” or “manufacture”
appear in 21 CFR Parts 803, 806, and 807. The Medical Device
Reporting regulation defines manufacturer to mean: “any person who
manufactures, prepares, propagates compounds, assembles, or
processes a device by chemical, physical, biological, or other
procedure. The term includes any person who either: (1) Repackages
or otherwise changes the container, wrapper, or labeling of a
device in furtherance of the distribution of the device from the
original place of manufacture; (2) Initiates specifications for
devices that are manufactured by a second party for subsequent
distribution by the person initiating the specifications; (3)
Manufactures components or accessories that are devices that are
ready to be used and are intended to be commercially distributed
and intended to be used as is, or are processed by a licensed
practitioner or other qualified person to meet the needs of a
particular patient; or (4) Is the U.S. agent of a foreign
manufacturer.” 21 CFR 803.3.
FDA’s regulation requiring reports of corrections and removals
defines manufacturer to mean: “any person who manufactures,
prepares, propagates, compounds, assembles, or processes a device
by chemical, physical, biological, or other procedures. The term
includes any person who: (1) Repackages or otherwise changes the
container, wrapper, or labeling of a device in furtherance of the
distribution of the device from the original place of manufacture
to the person who makes final delivery or sale to the ultimate user
or consumer; (2) Initiates specifications for devices that are
manufactured by a second party for subsequent distribution by the
person initiating the specifications; or (3) Manufactures
components or accessories which are devices that are ready to be
used and are intended to be commercially distributed and are
intended to be used as is, or are processed by a licensed
practitioner or other qualified person to meet the needs of a
particular patient.” 21 CFR 806.2 (g).
Under FDA’s establishment and registration regulation,
registration and listing requirements apply to anyone engaged in
the manufacture, preparation, propagation, compounding, assembly,
or processing of a device, activities that are defined to include:
“the making by chemical, physical, biological, or other procedures
of any article that meets the definition of device in section
201(h) of the act. . . . includ[ing] the following activities: (1)
Repackaging or otherwise changing the container, wrapper, or
labeling of any device package in furtherance of the distribution
of the device from the original place of manufacture to the person
who makes final delivery or sale to the ultimate consumer; (2)
Initial importation of devices manufactured in foreign
establishments; or (3) Initiation of specifications for devices
that are manufactured by a second party for subsequent commercial
distribution by the person initiating specifications.” 21 CFR
807.3(d).
See 21 CFR 803.3 (definition of manufacturer) &
807.20(a)(2).
See 21 CFR 820.3(c).
See 21 CFR 807.65(a) & 820.1(a).
Medical purpose magnifiers are classified devices and regulated
either under 21 CFR 886.5840 – Magnifying spectacles (“devices that
consist of spectacle frames with convex lenses intended to be worn
by a patient who has impaired vision to enlarge images”), or under
21 CFR 886.5540 – Low-vision magnifiers (“a device that consists of
a magnifying lens intended for use by a patient who has impaired
vision. The device may be held in the hand or attached to
spectacles”).
The FDA’s review of these products indicates that the majority of
these other mobile apps that may meet the definition of a medical
device have functionality either to automate common medical
knowledge available in the medical literature or to allow
individuals to self-manage their disease or condition. Many of
these mobile medical apps also automate common clinician’s
diagnostic and treatment tasks using simple general purpose tools,
including spreadsheets, timers, or other general computer
applications, by performing logging and tracking. For example,
mobile medical apps that: log, track, and graph manually-entered
(keyed in) data that lead to reminders or alarms; act as data
viewers for patient education; organize, store, and display
personal health data, such as lab results, doctor visits, dosages,
calories consumed, etc.; or allow for general dose over the counter
(OTC) lookups and use drug labeling to provide information that is
typically available on a drug label, e.g., acetaminophen dosage for
children and adults.
See
21 CFR part 820.
See Final Rule, Current Good Manufacturing Practice (CGMP); Quality
System Regulation, 61 FR 52602 (October 7, 1996).
See
fns. 3 and 4.
This means that the FDA intends to exercise its discretion to
decline to pursue enforcement actions for violations of the
FD&C Act and applicable regulations by a manufacturer of a
mobile medical app, as specified in this guidance. This does not
constitute a change in the requirements of the FD&C Act or any
applicable regulations.
To meet this criterion, the mobile medical apps need not be
physically connected to the regulated medical device.
21 CFR 806.10 and 806.20.
Under 21 CFR 807.3(c), ”
Establishment”
is defined as “a place of business under one management at one
general physical location at which a device is manufactured,
assembled, or otherwise processed.”
See
21 CFR part 807.
See 21 CFR part 803.
Under 21 CFR § 806.1(b), the following actions are exempt from the
reporting requirements of part 806:
(1) Actions taken by device manufacturers or importers to improve
the performance or quality of a device but that do not reduce a
risk to health posed by the device or remedy a violation of the act
caused by the device.
(2) Market withdrawals as defined in § 806.2(h).
(3) Routine servicing as defined in § 806.2(k).
(4) Stock recoveries as defined in § 806.2(l).
SOURCE