FDA Issues Draft Guidance on Best Practices for Selecting Predicate Devices for 510(k) Notifications

This draft guidance is one of three documents the FDA released in its effort “to continue to modernize the 510(k) Program.”[1] The new draft guidance recommends four “best practices” to employ when selecting a predicate device used to support a 510(k) submission.

Under the law, for eligible devices[2], a manufacturer must submit a 510(k) notification at least 90 days before introducing its device into interstate commerce for commercial distribution. The proposed device must be found by the FDA to be substantially equivalent to a “predicate device” – which is an already legally marketed device.[3] The agency then “clears” the device for marketing.

In the new draft guidance, FDA is now providing four best practices for selecting the predicate device — and the agency wants applicants to include in their 510(k) notification how the best practices were used to select their predicate device.[4] In brief, these best practices are the following:

1. Predicate devices cleared “using well-established methods” including FDA-recognized voluntary consensus standards, an FDA guidance document, a qualified medical device development tool, or a widely available and accepted method published in the public domain or in the scientific literature.
2. Predicate devices that meet or exceed expected safety and performance standards. FDA recommends that in selecting a predicate device, the applicant consider any reported medical device-related adverse events, malfunctions, or deaths that may have played a role in the safety and effectiveness of the predicate device.
3. Predicate devices without unmitigated use-related or design-related safety issues. Here the FDA wants to be sure that there are no emerging signals or safety communications on the predicate device.
4. Predicate devices without an associated design-related recall.

The draft guidance provides links to FDA and other databases to assist applicants in determining whether their proposed devices meet these best practices. It also provides illustrative examples “that are intended to exemplify how the best practices … can be used.”

As part of the use of the best practices, FDA now also wants applicants to include in their 510(k) Summaries[5] a narrative explaining how they selected their predicate device(s) and how the best practices were used to support the submission.

If you have questions concerning this new guidance, please contact the Food, Drug, Medical Device & Cosmetic team at ArentFox Schiff.

[1] The other documents released by the FDA at the same time are draft guidances on Recommendations for the Use of Clinical Data in 510(k) Notifications and Evidentiary Expectations for 510(k) Implant Devices.

[2] In general, a 510(k) Notification is required for devices intended for human use for which a premarket approval application (PMA) is not required, unless the device is exempt from the 510(k) requirements under the Federal Food, Drug, and Cosmetic Act.

[3] A legally marketed device is one that was legally marketed prior to May 28, 1976 [the date of the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act], a device that has been reclassified from class III to class II or I, or a device which has previously found to be substantially equivalent through the 510(k) notification process.

[4] An applicant may use multiple predicate devices to help demonstrate substantial equivalence in certain circumstances, such as when features from two or more predicate devices are combined in the proposed new device for the same intended use.

[5] A 510(k) notification must include either a “510(k) Summary” or a “510(k) Statement”, which is released to the public following clearance of the 510(k) notification. FDA “encourages” 510(k) Summaries rather than “510(k) Statements to facilitate transparency and to provide a brief discussion of the nonclinical tests submitted, referenced, or relied on in the notification.