Without mandated reporting, medical device supply chain is blurry: FDA officials warn

FDA officials are warning that medical device shortages could worsen now that the public health emergency has expired because with its end a requirement for medical device companies to notify the agency of shortages also ceased. 

In a May 22 article published in HealthAffairs, two officials from the FDA's Center for Devices and Radiological Health, Suzanne Schwartz, MD, and Tammy Beckham, DVM, PhD, detailed their concerns regarding the resiliency of the medical device supply chain.

During 2020 under the CARES Act, this division of the FDA was given authority to enforce manufacturers to report any supply chain disruptions through 506J notifications. Now that this act has expired along with the PHE, medical device manufacturers' obligation to report supply chain issues is only voluntary. 

"This means that the CDRH has an incomplete picture of potential shortages, making it harder for us to proactively build resilience in the medical device supply chain," they wrote. 

With a more blurry picture of what the medical device supply chain looks like, they warn that critical devices like catheters, ventilators, test equipment and syringes can place patient lives at risk. 

As such, they urge for legislative enforcement of mandatory reporting and risk analysis for manufacturers in order to proactively work toward prevention of future shortages.

"The CDRH is prepared to work with manufacturers to implement lessons learned during the COVID-19 PHE," they wrote. "We are committed to pursuing a least burdensome approach to 506J notifications for only the most critical devices, and only for circumstances that are likely to lead to a meaningful disruption in the supply of the device."

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