On April 12, the FDA released draft guidance discussing an expansion of its Abbreviated 510(k) program for medical devices. This new guidance would allow a submitter to establish substantial equivalence by demonstrating that a new medical device meets certain performance criteria, rather than by submitting direct comparison testing against a predicate device. The intention of the Expanded Abbreviated 510(k) program is to increase the efficiency and efficacy of the 510(k) program for device manufacturers, the reviewing agency, and healthcare professionals and patients alike.
What Is the Expanded Abbreviated 510(k) Program?
Under the 510(k) program, a medical device can be cleared by the FDA if it is found to be substantially equivalent to a predicate device. This guidance aligns with Congress’s amendment in section 513(i)(1)(D) of the FD&C Act to ensure that FDA considers the least burdensome means of demonstrating substantial equivalence.
This guidance addresses the prong of the substantial equivalence analysis that requires a submitter to demonstrate that, despite technological differences, its medical device is as safe and effective as a legally marketed device.
Under the Abbreviated 510(k), a submitter may use conformity to FDA standards, guidance, or special controls to demonstrate some of the performance characteristics necessary to support a finding of substantial equivalence. The Expanded Abbreviated 510(k) program, announced in this guidance, would allow the user to demonstrate all of the performance characteristics to establish substantial equivalence.
Establishing Substantial Equivalence with Performance Criteria
Traditionally, the way to show substantial equivalence between new devices and predicate devices is direct comparison testing. This is, of course, costly to perform. This new guidance allows the FDA to review data showing that the new device meets or exceeds the level of performance of appropriate predicate device(s). Thus, a submitter could demonstrate conformance to objective performance criteria established in FDA guidance, FDA-recognized consensus standards, and/or special controls. By meeting these identified performance criteria, a submitter could demonstrate the new device is at least as safe and effective as the legally marketed device pursuant to sections 513(i)(1)(A)(ii)(I) and 513(i)(1)(D) of the FD&C Act.
There are some caveats. To utilize this method: (1) the new device’s indications for use and technological characteristics must not raise different questions of safety and effectiveness as the predicate, (2) the performance criteria must align with the performance criteria of the predicate device, and (3) the new device must meet the performance criteria.
If you have questions whether your new device is appropriate for this Expanded Abbreviated 510(k), you can directly ask the FDA through the Q-Submission program, [1] and the FDA should provide an answer without the need to review any data.
What Data to Submit to Establish Performance Criteria
There are three types of submissions that may be required to demonstrate your new device meets the relevance performance criteria:
- A declaration of conformity to the standard;[2]
- A summary report; and
- Underlying data demonstrating the new device meets the FDA-identified performance criteria.
The declaration of conformity is required in all cases. Where the performance criteria and testing methodologies used are from an FDA-recognized standard, then the declaration of conformity should be sufficient for the FDA’s review.
A summary report will be necessary where the performance criteria are established by guidance and/or special controls.
Finally, the submitter must provide the underlying data if the guidance, special control, or standard does not identify specific testing methodologies.
This guidance is a step in the right direction in terms of improving and expediting medical device clearance for all parties involved. Clearly, for medical device manufacturers, this type of submission is less burdensome and costly. In turn, there will be less encumbrance on the FDA and this may result in shorter review times, although the program will be just as robust. Finally, the guidance benefits healthcare professionals and patients, who will have more safe and effective devices from which to choose as well as knowledge that a new device meets a transparent set of performance criteria.
[1] See “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff – Guidance for Industry and Food and Drug Administration Staff,” available at https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm311176.pdf.
[2] See “Required Elements for a Declaration of Conformity to a Recognized Standard (Screening Checklist for All Premarket Notification (510(k)) Submissions)” available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm142706.htm.
