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Recommendations on FDA device reviews

The US FDA has issued two reports containing preliminary recommendations concerning plans to overhaul the way it clears medical devices for marketing

The US Food and Drug Administration (FDA) has issued two new reports containing preliminary recommendations related to the agency's plan to overhaul the way it clears medical devices for marketing.

The FDA's Center for Devices and Radiological Health (CDRH) issued one report on how  to "strengthen and clarify" the 510(k) premarket review process, which is intended for medical devices that do not need to undergo a full pre-market approval review, and another, related document evaluating CDRH's use of new scientific information in decision-making.

The assessments were conducted by two staff committees created by CDRH last year. The panels based the reviews on public meetings, open dockets, data analyses, and input from CDRH staff.

"In recent years, concerns have been raised both inside and outside of the FDA about whether the current 510(k) programme achieves its goals of making safe and effective devices available to the public while fostering innovation," the FDA explained.

"Concerns about the programme have centered on whether it allows devices to enter the market without sufficient safety and effectiveness evidence and whether a lack of predictability, consistency, and transparency is hindering device development."

Among many other suggestions, the reports recommend that CDRH consider requiring additional information as part of premarketing submissions, including "revising regulations to explicitly require 510(k) submitters to provide a summary of all scientific information known or that the submitter should reasonably know regarding the safety and effectiveness of the device under review." That information is not currently required.

The reports also recommend that CDRH develop a web-based network of outside experts to help agency staff evaluate new science without serving in an advisory capacity. In addition, CDRH is advised to update its 510(k) database to include additional information such as summaries of FDA review decisions, current labelling and photos.

Both reports can be downloaded in full from the FDA

5th August 2010

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