FDA’s new draft guidance on selecting predicate devices for 510(k)

FDA’s new draft guidance on best practices for selecting predicate devices for 510(k) notifications!

As per the latest draft guidance issued by the US Food and Drug Administration (FDA), 4 “best practices” are mentioned for the process of selection of predicate device for a 510(k) program.

In accordance with the law, for all the eligible devices a manufacturer needs to submit a 510(k) notification at least 90 days before the device is introduced into interstate commerce for commercial distribution.

It is critical that the proposed device is substantially equivalent to the selected predicate device. Along with that, it is important that agency includes how the best practices were used to select the said predicate device in their 510(k) application.

You can also explore our article on 13 mistakes to avoid during 510(k) application.

List of best practices declared in the new draft guidance for selecting predicate device –

A predicate device must be cleared as per the well-established methods like FDA recognized voluntary consensus standards, an FDA guidance document, widely available and accepted method published in the public domain or scientific literature, or qualified medical device development tool.
Only a predicate device that meets or exceeds expected safety and performance standard must be selected. FDA recommends that while selecting a predicate device, the applicant must consider any reported medical device-related adverse event, malfunctions, or deaths that may have played a role in the safety and effectiveness of the predicate device.
FDA needs to be sure that there are no safety concerns with the selected device. Appropriate documentation must be added in the application if the selected predicate device comes with unmitigated use-related or design related safety issues.
Predicate devices without an associated design-related recall.

Included in the new draft guidance are the links to FDA and other databases to assist applicants in determining whether the proposed device meets all the best practices or not.

You will also find several examples that will reflect the best practices in play.

On top of all this, FDA also wants applicants to include 510(k) summaries in their application. These summaries must include the narrative explaining how they selected their predicate device & how best practices were used to support their submission.

Source

In case, you need assistance with your 510(k) submission, you can contact our experts at Elexes Medical Consulting.

Elexes Team

Elexes medical consulting is one of the leading regulatory & compliance consultant for several industries: Medical device, Pharmaceuticals, Cosmetics, Food, and Biologics.