FDA Taking Steps to Prevent Future Medical Device Shortages

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Knobbe Martens

The medical device industry experienced significant supply chain disruptions during the COVID-19 pandemic.  Such disruptions caused shortages of PPE, ventilators, diagnostic testing, and other medical devices.  As Janet Woodcock, M.D., the Acting Commissioner of Food and Drugs, acknowledges in her July 21, 2021 statement:

“the pandemic has exposed great weaknesses in the medical device supply chain and its dependence on foreign medical devices.”

Woodcock also explains the steps being taken by the FDA to avoid such shortages in the future.  One step includes a request for $21.6 million to fund a new Resilient Supply Chain and Shortages Prevention Program (RSCSPP).  This funding request is part of the FDA’s request for $97 million to support its core safety programs.  Woodcock explains “the funding will provide, for the first time, resources to establish a permanent program for U.S. supply chain resilience for medical devices.”  RSCSPP’s goal is to prevent and mitigate the supply chain issues like those experienced during the pandemic while reducing dependence on foreign medical devices.

Additionally, the FDA is looking to expand its authority to prevent future shortages.  The FDA seeks broader authority “to obtain supply disruption notifications for critical devices.”  Authority has also been requested “to require manufacturers to develop and share risk management plans.”  The FDA plans to work with Congress to ensure the FDA has the resources and authority needed to advance these initiatives.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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