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FDA Seeks Public Views on Proposed 510(k) Plans

August 01, 2011

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The US Food and Drug Administration today said that it has opened a public comment period in response to a new report from the Institute of Medicine calling on the agency to make substantial changes to the way it reviews medical devices.

The FDA’s Center for Devices and Radiological Health will receive comments through Sept. 30 concerning the IOM report, “Medical Devices and the Public’s Health, The FDA 510(k) Clearance Process at 35.”

In the report, which was commissioned by FDA as part of a larger agency review process, IOM recommended that FDA should replace its current premarket approval process in favor of a hybrid model that would emphasize post-market review and rely less on the similarities between proposed medical devices and others that have already been approved.

Today, FDA stated that the opening of the public comment period does mean that it endorses the IOM recommendations and that it will not adopt any of those recommendations before the end of the comment period.

Upon the release of the report, CDRH Director Jeffrey Shuren released a response arguing that the 510(k) process is not broken and that activities are already underway and more are in development to revamp the program to make it more effective.

“FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs,” Shuren said in a statement Friday.

“While FDA has not yet had the opportunity to fully evaluate this report,” the agency stated today in its public docket announcement, “[it] does recognize the strong public interest in the comprehensive assessment of the 510(k) process and the IOM report.”