Responding to growing concerns over the effectiveness and consistency of FDA’s 510(k) Premarket Notification process, the agency’s Center for Devices and Radiological Health (CDRH) recently released two reports (Volume I and Volume II) that offer broad recommendations on how to reform the device clearance process. The reports were developed by an internal 510(k) working group and the Task Force on the Utilization of Science in Regulatory Decision Making. Both reports focus on the need for FDA to ensure public safety while creating a predictable regulatory environment that fosters innovation.
The first report focuses on strengthening the premarket notification process, while the second examines the role science plays in CDRH’s decision-making. The proposed reforms, which have the potential to affect 90% of devices that enter the market, include splitting the Class II device category into “a” and “b” subsets, solidifying FDA’s authority to rescind 510(k)s, and modifying the “de novo” classification process for moderate risk devices.
“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. “The agency is ready to make necessary improvements to support device innovation while assuring patients receive safe and effective devices.”

FDA is holding a 60-day comment period to receive input on the proposed changes, all of which it emphasizes are strictly preliminary. Shuran said, however, that following the comment period, “some of the recommendations could actually be implemented within a matter of weeks or months.”

[Source: Hearing Industries Association]