USA – Exemptions for Unclassified Devices: CDRH Updates Guidance

The US Food and Drug Administration (FDA) on Friday updated a guidance from 2015 describing its intent to exempt certain unclassified medical devices from premarket notification requirements.

“Until the publication of a final rule exempting these devices from 510(k), FDA does not intend to enforce compliance with 510(k) requirements for these devices. FDA does not expect manufacturers to submit 510(k)s for these devices during this time period,” the guidance says…