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Medical Devices / Regulatory Affairs

FDA Issues Final Rule on Reclassification of Devices

Dec. 19, 2018
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The FDA issued a final rule streamlining its classification procedures for medical devices and allowing for changing classifications by administrative orders rather than the rulemaking process

The final rule follows up on a proposal issued in 2014 that uses authority granted under the Food and Drug Administration Safety and Innovation Act of 2012. The agency makes clear it can reclassify any higher-risk class III device to either class I or class II.

In the case of reclassification proceedings based on new information and proceedings calling for PMAs for a pre-FDASIA class II device, the agency must convene a classification panel and obtain panel recommendations on classifications.

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