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The FDA has issued draft guidance that would give certain Class I and Class II radiology and in vitro diagnostic devices a reprieve from the 510(k) clearance process.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

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