James A. Boiani, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Bloomberg Health Law & Business, in “FDA Moves to Modernize Medical Devices Premarket Program,” by Nyah Phengsitthy. (Read the full version – subscription required.)

Following is an excerpt:

The Food and Drug Administration released a trio of guidances Wednesday aimed at modernizing a process regulating medical devices.

The agency published three draft guidances to improve the predictability, consistency, and transparency of the Premarket Notification 510(k) Program, which allows manufacturers to say that their devices can be marketed through FDA regulation.

The draft guidances recommend practices for selecting a predicate device for the program, situations when clinical data may be necessary in a 510(k) submission, and evidentiary expectations for 510(k) submissions for implanted devices, according to the FDA.

“In light of this increasing technological complexity, clinical data are increasingly necessary in a 510(k) submission to support substantial equivalence,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

Safe and Effective

A 510(k) is a premarket submission made to FDA by manufacturers to demonstrate that their device to be marketed is as safe, effective, and substantially equivalent to a legally marketed device. Submitters must compare their device to one or more similar legally marketed devices and make and support their claims, the FDA said.

The draft guidances also help fulfill commitments from the FDA’s five-year agreement with the medical device industry signed into law last year, the agency said in a statement.

Manufacturers might push back on regulation and the additional review layer, despite it being a draft guidance, said James Boiani, attorney at Epstein Becker & Green.

“Some companies will like the additional certainty this provides, others will dislike it because it could lead to some lack of flexibility,” Boiani said.

“Even if it’s not legally binding, they’re trying to make an industry standard for, this is how you evaluate the best predicate that’s going to be the safest for people to use,” he said.

The agency is accepting comments on the guidances until Dec. 6.

“We intend to finalize these three guidances and use other opportunities to continue to strengthen and modernize other aspects of the 510(k) Program to help deliver safe, effective and high-quality medical devices to patients,” Shuren said in the statement.

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