FDA Releases 510(k) Report and Plan of Action

Yesterday, the FDA’s Center for Devices and Radiological Health (CDRH) released a report summarizing public comments related to initial recommendations released in August 2010, as well as a plan containing 25 actions for implementation in 2011.

This information is central to several programs on 510(k) reform hosted recently by IHIF and the Indiana Medical Device Manufacturer’s Council (IMDMC). We will continue to follow this issue and provide updated information as it becomes available.

Please click here for a copy of the report.

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