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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.”

Medical Device Innovations Report
Cutting-edge packaging technologies are transforming the medical device sector in PMMI’s “Innovation in Medical Device” report, featuring advanced materials, smart solutions, and evolving regulations. Editors share insights from nearly 300 PACK EXPO booth visits—each product deemed new and truly innovative—alongside video demonstrations of the equipment and materials on display.
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Medical Device Innovations Report
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Break out of the ordinary: see what’s new in life sciences packaging