Guidance for Industry and Food and Drug Administration Staff – FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmet…

For questions for the Center for Devices and Radiological Health
regarding this document contact the Premarket Notification (510(k))
Section at 301-796-5640.

For questions for the Center for Biologics Evaluation and
Research regarding this document contact the Office of
Communication, Outreach and Development at 1-800-835-4709 or
301-827-1800.

Contains Nonbinding
Recommendations

Preface

Public Comment

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and Drug Administration, 5630 Fishers Lane, rm. 1061, (HFA-305),
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Identify all comments with the docket number listed in the notice
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may not be acted upon by the Agency until the document is next
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Additional Copies

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send an e-mail request to
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guidance or send a fax request to 301-847-8419 to receive a hard
copy. Please use the document number (1615) to identify the
guidance you are requesting.

Copies of the guidance are also available from:

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Center for Biologics Evaluation and Research

Food and Drug Administration

1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448

Phone: 800-835-4709 or 301-827-1800

E-mail:
ocod@fda.hhs.gov

Internet:
http://www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatoryInformation/default.htm

Guidance for Industry and
Food and Drug Administration Staff

FDA and Industry Procedures for
Section 513(g) Requests for Information under the Federal Food,
Drug, and Cosmetic Act

Purpose

The purpose of this guidance is to establish procedures for
submitting, reviewing and responding to requests for information
regarding the class in which a device has been classified or the
requirements applicable to a device under the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) that are submitted in
accordance with section 513(g) of the FD&C Act, 21 U.S.C.
360c(g).

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.

Section 513(a) of the FD&C Act (21 U.S.C. 360c(a))
establishes three classes of devices based on the regulatory
controls needed to provide reasonable assurance of their safety and
effectiveness: class I (general controls), class II (special
controls in addition to general controls), and class III (premarket
approval in addition to general controls).

Under section 513(f) of the FD&C Act (21 U.S.C. 360c(f)),
post-amendments devices (devices that were not in commercial
distribution before May 28, 1976, the date the Medical Device
Amendments were enacted) are classified in Class III. However, FDA
may reclassify a post-amendments device (as Class I or II) or
determine that such a device is “substantially equivalent”
(SE)
¹ to either another post-amendments device that has been
classified into Class I or II or to a pre-amendments device for
which premarket approval is not required.
² Thus, a post-amendments device may be subject to
regulation as a Class I or II device in certain circumstances,
including when:

• the device is within a type of device that has been classified
  into class I or II and FDA has found the device to be SE to a
  device within such type;
• the device is within a type of pre-amendments device which is
  to be classified under section 513(b) of the FD&C Act (21
  U.S.C. 360c(b)) and FDA has found the device to be SE to a device
  within such type (an unclassified device type); or
• FDA has classified or reclassified the device type in class I
  or II in accordance with sections 513(f)(2) or 513(f)(3) of the
  FD&C Act (21 U.S.C. 360c(f)(2), (3)).

Pursuant to section 513(d) of the FD&C Act (21 U.S.C.
360c(d)), FDA promulgates classification regulations classifying
devices by generic type. A “generic type of device” is “a grouping
of devices that do not differ significantly in purpose, design,
materials, energy source, function, or any other feature related to
safety and effectiveness, and for which similar regulatory controls
are sufficient to provide reasonable assurance of safety and
effectiveness.” (See 21 CFR 860.3(i)). FDA has issued regulations
classifying the vast majority of pre-amendments devices (devices
that were in commercial distribution before May 28, 1976) by
generic type of device. See 21 CFR 860.84. Each classification
regulation, located at 21 CFR parts 862-892, indicates in which
class (I, II, or III) FDA has classified the device type. While the
great majority of device classifications codified in 21 CFR parts
862-892 are of pre-amendments devices, some of these
classifications are of post-amendments devices.

A. General Information

You can obtain information about device classification and
regulatory requirements applicable to a type of device in several
ways. FDA’s device regulations may be found at 21 CFR parts 800 –
898; the regulations classifying device types are located at 21 CFR
parts 862 – 892. The
CDRH classification resources on the CDRH web site can help you
quickly ascertain how your device type may be classified. You can
also obtain information about the regulatory requirements that may
apply to a particular type of device on FDA’s web site (see
resources below).

• 
  Product Classification Database
• 
  510(k) Database
• 
  Premarket Approval Database
• 
  Class I and Class II Devices Exempt from 510(k)
  Requirements
• 
  Device Guidance Documents
• Division of Small Manufacturers International and Consumer
  Assistance

  800-638-2041 or 301-796-7100, or by email at
  dsmica@cdrh.fda.gov

• Office of
  Combination Products, 301-796-8930, or by email at
  combination@fda.gov
• 
  Information regarding particular types of devices regulated by
  CBER.

If the resources listed above do not address your question, you
may contact the premarket review branch chiefs for more
information. Contact information for the Office of Device
Evaluation (ODE) is available at
the CDRH Management Directory By Organization (ODE). Contact
information for the Office of In Vitro Diagnostics Evaluation and
Safety (OIVD) is available at
the CDRH Management Directory By Organization (OIVD). Contact
information for CBER is available at
Contacts in the Center for Biologics Evaluation & Research
(CBER).

B. Section 513(g) Request for Information

Section 513(g) of the FD&C Act (21 U.S.C. 360c(g)) provides
a means for obtaining the agency’s views about the classification
and the regulatory requirements that may be applicable to your
particular device. This provision states:

Within sixty days of the receipt of a written request of any
person for information respecting the class in which a device has
been classified or the requirements applicable to a device under
this Act, the Secretary shall provide such person a written
statement of the classification (if any) of such device and the
requirements of this Act applicable to the device.

Section 513(g) governs requests “for information respecting the
class in which a device has been classified or the requirements
applicable to a device under [the] Act.” Submissions that do not
request such information are outside the scope of section
513(g).

If, based solely on the information provided with a 513(g)
Request for Information, the product at issue does not appear to be
a “device” within the meaning of section 201(h) of the FD&C Act
(21 U.S.C. 321(h)), FDA will so inform the requester in our
response. If, based solely on the information provided with the
request, the product does appear to be a “device” within section
201(h) of the FD&C Act, FDA will generally provide the
following information regarding device classification and
applicable FDA regulatory requirements:

• the agency’s assessment, based on the information submitted in
  the request, as to the generic type of device (e.g., classification
  regulation) that the requester’s device appears to be within (if
  any);
• the class of devices within that generic type (and if there is
  more than one class within that generic type, the particular class
  within which the requestor’s device appears to fall);
• whether a PMA, 510(k), or neither is required in order to
  market devices of the particular class within that generic
  type;
• other requirements applicable to devices of the particular
  class within that generic type;
• whether a guidance document has been issued regarding the
  exercise of enforcement discretion over the particular class of
  devices within that generic type;
• whether additional FDA requirements may apply, such as those
  applicable to radiation-emitting products.

FDA does not review data related to substantial equivalence or
safety and effectiveness in a 513(g) Request for Information. FDA’s
responses to 513(g) Requests for Information are not device
classification decisions and do not constitute FDA clearance or
approval for marketing. Classification decisions and clearance or
approval for marketing require submissions under different sections
of the FD&C Act. The most common method of seeking a
classification decision is to submit a premarket notification in
accordance with section 510(k) of the FD&C Act (see 21 CFR part
807, subpart E – Premarket Notification Procedures).

FDA’s response to a 513(g) Request for Information will
not address the specific types of nonclinical, animal, or clinical
testing appropriate to support clearance or approval of a marketing
application (when required). You may send a pre-submission to the
Document Control Center for review by the appropriate review branch
to receive more specific information about your specific testing
recommendations (for CDRH, see
IDE Approval Process; for CBER, use contact information
supplied on the 513(g) Request for Information response letter
).

A 513(g) response does not constitute final Agency action, but
provides responsive information based on the information provided
by the requestor.

C. Formal Jurisdictional Determinations within FDA

If it is unclear to you which Center has jurisdiction over your
product, including any combination product for which the lead
Center has not yet been determined, it may be appropriate to
contact the Office of Combination Products (OCP) to discuss your
product’s jurisdiction and whether to submit a formal Request for
Designation (RFD) under section 563 of the FD&C Act ( 21 U.S.C.
360bbb-2) rather than submitting a 513(g) Request for Information.
The RFD process is used to obtain a formal agency determination
concerning the classification of a product as a drug, device,
biological product, or combination product subject to section
503(g) of the FD&C Act ( 21 U.S.C. 353(g)),
³ and/or respecting which agency component(s) will
regulate the product.

Contact information for OCP and comprehensive information on how
to write an RFD can be found at Combination
Products.

A 513(g) Request for Information must be submitted in writing
and should be identified as a 513(g) Request for Information.

For submissions to CDRH, two copies of the request should be
sent to:

U.S. Food and Drug Administration

Center for Devices and Radiological Health

Document Mail Center – WO66-G609

10903 New Hampshire Avenue

Silver Spring, Maryland 20993-0002

For submissions to CBER, two copies of the request should be
sent to:

CBER 513(g) Coordinator

Quality Assurance Staff (HFM 4)

c/o Document Control Center (HDM-99)

Center for Biologics Evaluation and Research

1401 Rockville Pike, Suite 200N

Rockville, MD 20852

User Fees

The Act, as amended by the FDA Amendments Act of 2007 (FDAAA)
(Public Law 110-85), requires FDA to collect user fees for 513(g)
Requests for Information. See section 738(a)(2)(A)(ix) of the
FD&C Act (21 U.S.C. 379j(a)(2)(A)(ix)). FDA may not accept your
513(g) for review until you have paid all fees owed, including all
required establishment registration fees. See section 738(f)(1) of
the FD&C Act (21 U.S.C. 379j(f)(1)). When FDA has received all
fees owed, our review of your 513(g) Request for Information will
begin as of that date.

As explained above, if the submission does not request
information respecting the class in which a device has been
classified and/or the requirements applicable to a device under the
Act, it is not a Request for Information governed by section 513(g)
of the Act. Such requests do not require a response from FDA. FDA
intends to refund any user fee submitted with a request that is not
governed by section 513(g) of the FD&C Act.

For additional information on user fees for 513(g) requests for
information see the guidance document “User Fees and Refunds
for 513(g) Requests for Information.”

The 513(g) Request for Information should contain the
following:

• a cover letter,
• a description of the device,
  ⁴
• a description of what the device is to be used for, and
• any proposed labeling or promotional material for the device
  and, as applicable, any labeling or promotional material of a
  similar, legally marketed device, if available.

Cover Letter

Your cover letter should identify your request as a
“513(g) Request for Information.” Your cover letter
should include:

• the date of the request,
• the name of the device,
• your specific question(s) concerning the class in which a
  device has been classified and/or the regulatory requirements
  applicable to a device,
• the requestor’s name, address, telephone number, fax
  number, and email address,
  ⁵ and
• the 513(g) requestor’s signature.

Description of the Device

As applicable, the description of the device should include:

• a list of materials and components used in/with the
  device,
• photographs, engineering drawings, and/or samples of the
  device,
  ⁶
• a summary of the device’s operational principles,
• a description of the type and amount of energy to be used or
  delivered by the device, and
• a description of similar devices in commercial distribution in
  the United States , if available.

Device Uses

You should include the following information:

• the disease or condition with respect to which the device is to
  be used
• prescription versus over-the-counter use,
• part of the body or type of tissue applied to or interacted
  with,
• frequency of use,
• physiological purpose (e.g., removes water from blood,
  transports blood, etc.),
• patient population; and
• any other labeling information related to the patient use of
  the device.

Labeling

You should provide any proposed labeling, including proposed
promotional material for the device or any labeling or promotional
material of a similar, legally marketed device. If no proposed
labeling is available for the described device or for a similar
legally marketed device, this should be noted in the cover
letter.

Additions to a 513(g) Request for
Information

Once FDA has received your 513(g) Request for Information and
user fee, you may not modify that 513(g) request by subsequently
adding a new question, use, or technology. We would consider the
addition of a new question, use, or technology to a pending Request
for Information to be a new 513(g) request subject to an additional
user fee, to which we intend to respond separately.

Upon receipt of the 513(g) Request for Information and the
necessary user fee, the Document Control Center (DCC) will assign a
submission number to the 513(g) Request for Information and forward
the request to a review branch in ODE or OIVD for consideration.
The DCC will send an “acknowledgement of receipt” letter to the
submitter of the 513(g) Request for Information. The 513(g) Request
for Information will generally be accepted for review by a branch
in ODE or OIVD. Staff from ODE or OIVD and other Offices within
CDRH with appropriate scientific and regulatory expertise will
review the information provided, meet as necessary, and draft a
response for signature by the Director, ODE or Director, OIVD. The
response should be responsive to the regulatory question(s) asked
in the 513(g) Request for Information.

Upon receipt of the 513(g) Request for Information and the
necessary user fee, the Document Control Center (DCC) will forward
the submission to the CBER 513(g) Coordinator who will assign a
submission number to the 513(g) Request for Information. The CBER
513(g) Coordinator will then review the 513(g) Request for
Information for completeness, confirm the request is for
information respecting the class in which a device has been
classified and/or the requirements applicable to a device under the
FD&C Act, and send an “acknowledgement of receipt” letter to
the submitter of the 513(g) Request for Information. The 513(g)
Request for Information will generally be assigned to one of the
product review offices for consideration. Staff from the assigned
product review office and other personnel within CBER with
appropriate scientific and regulatory expertise will review the
information provided, meet as necessary, and draft a response for
signature by the director of the assigned product review office.
The response should be responsive to the regulatory question(s)
asked in the 513(g) Request for Information.

VII. Responding to a 513(g) Request for Information in CDRH or
CBER

Our response to a 513(g) Request for Information will be
responsive to the questions posed in the request. We intend to
issue our response within 60 days of receipt. Our response will
generally fall into one of the following categories indicating
that, based solely on the information provided in the 513(g)
Request for Information; it appears that the product you have
identified is:

• a device within the meaning of section 201(h) of the FD&C
  Act, and
• • appears to be a an unclassified pre-amendments device type and
    therefore is subject to the 510(k) requirement;
  • appears to be a post-amendments device type that has not yet
    been re-classified and therefore is subject to the PMA requirement;
    or
  • appears to be a device that is a classified device type. We
    will generally identify the generic type of device (e.g.,
    classification regulation) that your device appears to be within,
    the class of devices within which your device appears to fall, and
    the type of submission, if any, required in order to market devices
    of the particular class within that generic type:
  • • Class I or II subject to the 510(k) requirement;
    • Class I or II exempt from the 510(k) requirement;
    • Class III subject to the 510(k) or PMA requirements; OR
• not a device,
• • but may be another type of product regulated by FDA. In this
    case, we would provide you with contact information for another
    component within FDA; or
  • and appears not to be a product for which FDA has jurisdiction;
    OR
• a combination product where it is not clear which Center has
  primary jurisdiction. If you would like to discuss further the
  assignment of this product, we recommend you contact the Office of
  Combination Products.

Ifyour 513(g) Request for Information is incomplete and we are
unable to provide information regarding classification and/or
applicable requirements because you have not submitted sufficient
information to us, we intend to contact the submitter and request
additional information. If FDA does not receive a response within
30 days of our request, we may consider a 513(g) to be withdrawn.
In this instance, FDA may issue a notice of withdrawal.

This guidance contains information collection provisions that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C.
3501-3520).

The time required to complete this information collection is
estimated to average 12 hours per response, including the time to
review instructions, search existing data sources, gather the data
needed, and complete and review the information collection. Send
comments regarding this burden estimate or suggestions for reducing
this burden to:

510(k) Staff, Program Operations Staff, Office of Device
Evaluation, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver
Spring, MD 20993.

This guidance also refers to currently approved collections of
information found in FDA regulations. The collections of
information in 21 CFR 807 subpart E have been approved under OMB
control number 0910-0120; the collections of information in 21 CFR
part 814 have been approved under OMB control number 0910-0231; the
collections of information in 21 CFR part 801 have been approved
under OMB control number 0910-0485; and the collections of
information in 21 CFR 860.123 have been approved under OMB control
number 0910-0138.

¹
Substantial equivalence is defined at section 513(i) of the
FD&C Act (21 U.S.C. 360c(i)). FDA generally evaluates
substantial equivalence on the basis of a premarket notification
submitted pursuant to section 510(k) of the FD&C Act (21 U.S.C.
360(k)). Certain devices are subject to a statutory exemption from
the 510(k) premarket notification requirement (see
sections 510(l) and (m) of the FD&C Act).

² A
pre-amendments device for which premarket approval is not required
could be a pre-amendments device that has been classified into
Class I or Class II, a pre-amendments device that has been
classified into Class III but for which a regulation under section
515(b) of the FD&C Act (21 U.S.C. 360e(b)) requiring the
submission of an application for premarket approval (PMA) has not
yet been issued, or a pre-amendments device that has not yet been
classified.

³
Combination product is defined at 21 CFR 3.2(e).

⁴ A 513(g)
Request for Information should seek classification information
and/or regulatory requirements for a single product and may include
multiple uses of the product. Requests for classification
information and regulatory requirements for multiple products
should be divided up so that a separate Request for Information and
user fee are submitted for each product.

⁵ You
should provide the contact information for a single point of
contact. The contact information should be associated with the
person submitting the Request for Information as the term person is
defined in section 201(e) of the FD&C Act.

⁶ Any
sample device can be returned at the request of the submitter.

SOURCE