A final list of 1,003 Class II medical device types exempted from premarket notification requirements under the 21st Century Cures Act, along with new product codes, has been released by the FDA. Companies that have pending 510(k) submissions for devices included on the list should discuss with the 510(k) lead reviewer if their device falls within the exemption's general limitations or if review needs to continue, the agency said.
List of Class II device types exempt from 510(k) requirements finalized by FDA
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