Medical Device Manufacturers Required To Report Shortages During Pandemic

The FDA's CDRH issued guidance, effective immediately, detailing new requirements for medical device manufacturers to notify it of shortages during the COVID-19 pandemic.

Historically, only drug manufacturers have been required to report shortages or discontinuances of their products to FDA. However, the newly passed CARES Act (Coronavirus Aid, Relief, and Economic Security Act) included new requirements for medical device manufacturers.


Specifically, manufacturers are now required to provide notice at least 6 months ahead of the discontinuance or interruption, for critical devices used during a declared public health emergency or devices deemed necessary by FDA. For more on the new requirements, read FDA's press release:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/notifying-cdrh-permanent-discontinuance-or-interruption-manufacturing-device-under-section-506j-fdc


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