After some delay, the Government Accountability Office has drafted a report on FDA's 510(k) submissions program, which some expect will recommend reforms to the Class II, medium-risk category of devices.

Industry reps have speculated that 510(k) reform legislation that may put more devices in the higher-risk pre-market approval (PMA) category could be introduced in Congress next year.

"We do have some reason to believe there's a lot of interest in products that were grandfathered - these are products that were on the market before the 1976 Medical Devices Amendments Act," AdvaMed's Elizabeth Pika Sharp said.

"We also know that there are some members of Congress that are concerned with the subjective nature - as they call it - of the 510(k) process."

According to GAO Health Care Director Marcia Crosse, the draft report is under review within GAO before it goes to FDA for comment.

"That report could spur some to propose changes to the 510(k) process, so we expect that to be a potentially vigorous debate," AdvaMed government affairs director Brett Loper said.

The report, mandated by the FDA Amendments Act and technically due to Congress on Sept. 27, will not be released in November as previously hoped, Crosse said (¹ Also see "GAO 510(k) Report May Recommend Splitting Up Class II, Industry Predicts" - Medtech Insight, 29 September, 2008., p. 5).

However, GAO did brief House Energy and Commerce Committee and Senate HELP Committee staffers on Oct. 1 on the report's contents. An Energy and Commerce aide said the committee is reviewing recommendations from the briefing.

Once FDA receives the draft report, it will have about two weeks to review and comment on it, Crosse said. GAO was waiting on additional data from FDA, which it received in early November, and so "we're finally now able to begin moving forward," she explained.

Possible 510(k) reform provisions could conceivably move through as part of import safety legislation, AdvaMed's Loper said.

Legislation on 510(k) reform could also originate with Rep. Rosa DeLauro, D-Conn., chair of the House Appropriations subcommittee responsible for FDA. "It's something that we're looking at," a DeLauro spokeswoman said. "It would appear that this process could need some reform."

- Jessica Bylander (j.bylander@elsevier.com)

GAO Drafts 510(k) Report; Talk Grows Of Pre-Market Reform Legislation In ’09

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