FDA to Begin Revamping the 510(k) Medical Device Review Program

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In September 2009, the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) established both the 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making to address a myriad of concerns over whether the operation of the 510(k) program was in fact predictable for medical device manufacturers, facilitated medical device innovation, and protected public health and safety. In August 2010, the working group and task force issued preliminary reports recommending a total of 55 changes to the 510(k) program. The FDA invited public and industry comment on the reports.

On January 19, 2011, the FDA announced that during the comment period it received feedback on each of the 55 recommendations; some of the recommendations received broad support, some received support with a suggested modification or caveat, and on some there were significant reservations. As a result, the FDA further announced that it planned to begin implementing 25 of the recommendations on which there was support, or support with some modification, focusing initially on recommendations that, per the FDA, will have the greatest impact on either fostering medical device innovation, enhancing regulatory predictability, or improving patient safety. Several of the remaining recommendations are being referred to the Institute of Medicine for feedback. Some will be implemented at a later point, after further consideration or modification. Click here to read the full FDA report.

Please see full advisory below for more information.

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