FDA 510(k) Exemption Guidance 2026: Five New Product Codes Exempted

Medical Device Global Market Access · Jun 10, 2026 · 4m

The US FDA issued a final guidance on June 4, 2026, immediately exempting five unclassified medical device product codes from 510(k) premarket notification requirements. This episode details the guidance, 'Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements,' explaining which manufacturers are affected, the scope of the FDA's enforcement discretion, and the critical regulatory obligations—like QMSR, registration, and listing—that remain in effect. We outline practical steps for regulatory teams to adapt their market access strategies in response to…