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.”

The guidance explains that, at this time, the FDA does not intend to enforce the following requirements before September 24, 2022:

  • UDI labeling (21 CFR 801.20 & 801.50)
  • Direct Mark (21 CFR 801.45)
  • GUDID Data Submission (21 CFR 830.300)
  • Standard Date Format (21 CFR 801.18) 

Download the guidance here: https://www.fda.gov/media/110564/download

Worker safety

CDRH recognized the need for reducing risk of COVID-19 exposure among medical device manufacturing personnel. The Center issued 10 recommendations for worker safety in device production environments, including engineering controls such as physical barriers and administrative controls (e.g. reducing the number of employees at a facility at one time).

View the full list here: Protecting the Health and Safety of Medical Device Manufacturing Personnel During COVID-19

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