FDA seeks to exempt certain devices from 510(k) process

12/22/2011 | AuntMinnie.com (free registration)

The FDA has issued draft guidance that would give certain Class I and Class II in vitro diagnostic and radiology devices a reprieve from the 510(k) clearance process. The FDA will use discretion in applying submission guidelines for those devices as it finalizes the proposed exemptions and classification downgrades.

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