FDA will demand more comprehensive data from a growing subset of 510(k) submissions, CDRH Director Daniel Schultz suggested at a recent industry meeting.

Pre-market notifications, or 510(k)s, are often the most efficient way for a manufacturer to get a device on the market, because they usually require less clinical data than a pre-market approval application. About 95% of devices go to market via the 510(k).

"This is a process and program that has really served industry well, the agency well and the American people well over the last 30 years," Schultz said March 13 at AdvaMed's annual meeting in La Quinta, Calif.

But Schultz acknowledged that many devices entering the market by proving substantial equivalence to a predicate device are "really very close to the edge in terms of whether they are 510(k) or PMA."

In some cases, a product's intended use is similar but not quite the same as a predicate device that forms the basis of a 510(k) submission, Schultz said. In other instances, the technology itself is distinguishable from the prior product.

In those cases, the agency will be asking for as much data as necessary, he said. "If that means that sometimes people are going to come in and say 'you are raising the bar,' so be it," he said. "As technology advances, to expect us to have a regulatory system locked into 1976 is frankly absurd."

Schultz's comments to AdvaMed members come as the 510(k) program is under public scrutiny. Public Citizen and other consumer advocacy groups criticized the program last year during congressional hearings leading up to passage of the FDA Amendments Act (¹ Also see "Scrutinizing 510(k)s: Critical Voices Get Heard In Congress" - Medtech Insight, 16 July, 2007., p. 6).

The bill ultimately included a requirement for the Government Accountability Office to study "the appropriate use" of 510(k)s, which industry reps privately worry could lay the foundation for statutory changes that would increase the burdens of these submissions.

"In order for you and me to go out and make a good case that this is really a risk-based program that provides rapid access ... but also safeguards the American public, we are going to need to be able to make the case that the 510(k) process is flexible" enough to handle devices that only require minimal information to prove substantial equivalence and also products that need more data, Schultz said.

- David Filmore (d.filmore@elsevier.com)

FDA Device Chief Issues Caution On 510(k)s: Data Requests Could Get Steeper

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