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WASHINGTON – The Food and Drug Administration is considering measures to strengthen and clarify a premarket review process for medical devices that do not need to undergo a full premarket approval review.

Under the proposal for the accelerated review process, called the 510(k) program, the FDA would issue guidance to clarify which devices can use the process. The agency is also considering creating a subset category for devices that would require more data in order to obtain approval.

In recent years, concerns have been raised both inside and outside of the FDA about the safety and effectiveness of the current 510(k) program. The process has also been criticized for producing unpredictable, inconsistent and nontransparent results, thus hindering device development.

The recommendations are based in part on assessments of the program commissioned by the FDA in 2009. FDA staff committees evaluated public input, data analyses and input from the staff of the agency’s Center for Devices and Radiological Health collected over the course of several months.

“Taken together, these preliminary reports show a smarter FDA – an agency that recognizes both sides of our mission to protect and promote public health,” said CDRH Director Jeffrey Shuren, M.D. “The agency is ready to make necessary improvements to support device innovation while assuring patients receive safe and effective devices.”

- Kimberly Atkins

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