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US FDA: 510(k)-Exempt Class II Devices Should Withdraw Applications

In line with the 21st Century Cures Act, US FDA has finalized a list of class II devices that will no longer need pre-market notification to get to market. Also, check out our updated Cures Act implementation table.

Sponsors of products on a final list of class II devices that are now exempt from 510(k) submissions should withdraw any submitted application, says US FDA. Complying with the 21st Century Cures Act passed last year, the agency has finalized a list of devices that will no longer need pre-market notification starting July 11.

Earlier this year FDA published a list of class II devices it was considering exempting from requiring 510(k)s including allergens used in immune system testing, drug tests for employers and denture supplies. The list included about a thousand device types, including some large representation of variations of similar devices. Stakeholders had until May 15 to comment on the list, but the final list is identical to the one proposed by the agency

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