Med Devices and the FDA: Extended Deadline, Worker Safety

In extending UDI compliance dates for low-risk products, FDA cited challenges related to COVID-19. CDRH also issued recommendations for personnel safety in med device manufacturing.

Udi

The FDA issued an immediately-in-effect guidance on Jul. 1, 2020 on its policy regarding compliance dates for class I and unclassified devices that are not implantable, life-supporting, or life-sustaining. 

The guidance cited coronavirus as one reason for the extension, noting that “for those labelers that have not already implemented UDI requirements for class I and unclassified devices, preparing to implement UDI requirements while addressing the challenges related to Coronavirus Disease 2019 (COVID-19) could be very difficult and could divert resources from COVID-19 response efforts. To the extent this policy helps labelers remain focused on public health needs related to COVID-19, we believe the policy is further consistent with the public health.”

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