FDA Drops Proposed Premarket Notification Exemptions for Class II Devices

May 6, 2021

The FDA has decided not to go forward with a Trump-era policy that would have exempted 83 class II medical devices from premarket notification requirements.

The agency said the basis for the proposed exemptions was “flawed” and that the Department of Health and Human Services issued the notice before consulting with the agency. In reversing the policy, the FDA said the determinations in the proposal were based solely on a tally of adverse events in the agency’s Manufacturer and User Facility Device Experience database (MAUDE).

Adverse events reported in MAUDE alone are an inappropriate basis for exemptions because adverse events may be under reported for certain devices and may not necessarily reflect the risk of injury, the agency noted.

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