Medical devices marketed in the United States are subject to the regulatory controls in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the regulations in Title 21- Code of Federal Regulations (21 CFR) Parts 1-58, 800-1299.
Medical devices that emit radiation are also subject to regulations for radiation-emitting electronic products cited in 21CFR Parts 1000-1050.
Some requirements apply to medical devices before they are marketed (premarket requirements), and other apply to medical devices after they are marketed (postmarket requirements).
Premarket Requirements
You must follow the steps below prior to marketing a medical device in the United States:
- Step One: Classify Your Device
- Step Two: Choose the Correct Premarket Submission
- Step Three: Prepare the Appropriate Information for your Premarket Submission to the FDA
- Step Four: Send your Premarket Submission to the FDA and Interact with FDA Staff during Review
- Step Five: Complete the Establishment Registration and Device Listing
Step One: Classify Your Device
The first step in preparing a device for marketing is to find the federal regulation that classifies your device. A medical device is defined by law in the section 201(h) of the FD&C Act, and the classification, which may be found in the Code of Federal Regulations, determines the regulatory path and regulatory requirements for your device.
While the FDA will officially classify your medical device when reviewing your premarket submission, it is helpful for you to identify the classification. This will allow you to select the correct regulatory submission path and become aware of the level of regulatory control that is necessary to assure the safety and effectiveness of the medical device.
Medical devices are categorized into one of three classes, based on the degree of risk they present. These classes are as follows:
- Class I – Lowest Risk
An example of a Class I device is a manual toothbrush. Class I devices are subject to general controls. - Class II – Moderate Risk
Examples of Class II devices are male condoms and non-invasive blood pressure monitors. Class II devices are subject to general controls and special controls. - Class III – Highest Risk
An example of Class III device is a heart valve. Class III devices are subject to general controls and premarket approval.
To find the classification regulation of your device, see:
Notes:
- For help determining whether a product is a medical device, refer to Device – Not a Device.
- If your product is a combination product – a medical device plus another FDA-regulated product (e.g. drug, biologics, etc.), you should contact FDA’s Office of Combination Product (OCP) by e-mail at: combination@fda.gov. Based on your product’s primary mode of action, OCP will tell you which FDA Center that you need to contact in order to market your product.
- Even if your medical device does not require a premarket submission, it is your responsibility to make sure you have the correct classification for your device.
Step Two: Select the Correct Premarket Submission
After the device classification, you then select the premarket submission required for that regulation. The most common types of premarket submissions include:
- 510(k) (Premarket Notification)
- PMA (Premarket Approval)
- De Novo (Evaluation of Automatic Class III Designation)
- HDE (Humanitarian Device Exemption)
510(k)
Some Class I and most Class II devices require a 510(k). In a 510(k), the sponsor must demonstrate that the new device is “substantially equivalent” to a predicate device in terms of intended use, technological characteristics, and performance testing, as needed. For information on how to prepare and submit a 510(k), see Device Advice Premarket Notification [510(k)].
Some Class I and Class II devices are exempt from 510(k) if they do not exceed the limitations of exemption stated in 21 CFR xxx.9, where xxx refers to 21CFR 862-892. For example, an elastic bandage classified under 21CFR 880.5075 is exempt from premarket notification, provided that it does not exceed the exemption limitations stated in 21CFR 880.9.
PMA
Most Class III devices require a PMA. A PMA is the most stringent type of premarket submission. Before the FDA approves a PMA, the sponsor must provide valid scientific evidence demonstrating reasonable assurance of safety and effectiveness for the device’s intended use.
For information on how to prepare and submit a PMA, see Device Advice Premarket Approval (PMA).
De Novo
De Novo provides a means for a new device, without a valid predicate, to be classified into Class I or II if it meets certain criteria.
For information on how to prepare and submit a De Novo request, please refer to these resources:
HDE
HDE provides a regulatory path for Class III devices that are intended to benefit patients with rare diseases or conditions. In order for a device to be eligible for an HDE, a sponsor must obtain designation as a Humanitarian Use Device (HUD), which is granted through application to FDA’s Office of Orphan Products Development (OOPD).
For information on how to request Humanitarian Use Designation, see Designating Humanitarian Use Device (HUD).
For information on how to prepare and submit an HDE application, please refer to these resources:
- 21CFR 814, Subpart H
- Humanitarian Device Exemption
Step Three: Prepare the Appropriate Information for the Premarket Submission
Once you have selected the correct premarket submission type, you must prepare the appropriate information that will be needed. In this section, we identify resources for assistance and information to consider when preparing your premarket submission.
Resources
The FDA has developed several types of resources to help you prepare your premarket submission. These include the following:
- Device Advice — comprehensive Web-based regulatory assistance
- To prepare a 510(k), please see Premarket Notification [510(k)]
- To prepare a PMA, please see Premarket Approval (PMA)
- CDRH Learn — video-based series of teaching modules, seminars, and recorded webinars that cover a variety of policy and guidance efforts
- CDRH Pre-Submission Program — prospective applicants of future premarket submissions may request feedback from the FDA through this program. Information about this resource may be found in the FDA guidance Request for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff. We encourage you to read our online information and other available resources prior to submitting any request for feedback.
Information to Consider When Preparing your Premarket Submission
Design Controls: All Class II and Class III devices must be designed in accordance with Design Controls under the Quality System Regulation (21 CFR 820.30). Some Class I devices are exempted from Design Controls. For guidance on Design Controls, please see: Design Control Guidance for Medical Device Manufacturers.
Nonclinical Testing: The types of information and testing required to market your device are determined by the device classification, mechanisms of operation, technological characteristics, and labeling. Nonclinical testing performed in support of a premarket submission for a medical device must comply with the Good Laboratory Practices (GLPs) in 21 CFR 58.
Clinical Evidence: PMAs, HDEs and some 510(k)s and De Novos require clinical evidence. Prior to initiating a clinical study, the study sponsor may need to obtain approval of an Investigational Device Exemption (IDE) by the FDA. The study will also need to be approved by the appropriate Institutional Review Board (IRB). Clinical studies must comply with all applicable IDE regulations and Good Clinical Practices (GCPs). For additional information on the IDE and GCP regulations, see Device Advice Investigational Device Exemption (IDE).
Labeling: The labeling for a device must be written according to labeling regulations and included in your premarket submission. For additional information, see Device Labeling.
Step Four: Send Your Premarket Submission to the FDA and Interact with FDA Staff during Review
Once you have assembled the appropriate information necessary for your Premarket Submission, you send your submission to the FDA and interact with FDA staff during review.
User Fees: There is a user fee associated with the submission of a 510(k) or a PMA. For more information on user fees, please see Premarket Notification (510(k)) Review Fees and PMA Review Fees respectively.
eCopy: Premarket submissions must include an electronic copy (eCopy) on a compact disc (CD), digital video disc (DVD), or a flash drive. For detailed information on eCopy, please see eCopy Program for Medical Device Submissions.
Administrative Filing Review: After a premarket submission is received, the FDA conducts an administrative review to assess whether the submission is sufficiently complete to be accepted for substantive review. Please see the Refuse to Accept Policy for 510(k)s or PMA Acceptance and Filling Review Policy.
Interactive Review: While a submission is under review, FDA staff communicates with applicants to increase the efficiency of the review process. Please see: Types of Communication During the Review of Medical Device Submissions.
Step Five: Complete Establishment Registration and Device Listing
A device facility must register its establishment and list its devices with the FDA. Information about how to register and list may be found at Device Registration and Listing.
If a device requires premarket clearance or premarket approval prior to marketing (i.e., the medical device is not exempt), the device firm must wait until it receives FDA clearance or approval before registering and listing.
Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote clearance or approval of the establishment or its products by the FDA.
