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Previous Blogs

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Regulatory Affairs FDA Guidances and Regulations Medical Devices 510(K)
The FDA released four final guidances pertaining to the 510(K) program

By Di Wu

十二月 17, 2019

The FDA’s Center for Devices and Radiological Health (CDRH) released four final guidance documents on Thursday, Sept. 12, which provides the FDA’s current thinking on the Special 510(K) program, the Abbreviated 510(K) program, how to format Traditional and Abbreviated 510(K)s and the new Refuse to Accept policy for 510(K).

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