Proposed US FDA program targets medical device supply chain shortages

A new program proposed by the US Food and Drug Administration would bolster domestic supply chains for medical devices during public health emergencies, but would also entail additional compliance work for manufacturers.

The Resilient Supply Chain and Shortages Prevention Program (RSCSPP), proposed in FDA’s FY 2022 budget, would be established within FDA’s Center for Devices and Radiological Health (CDRH). According to the agency, the RSCSPP will improve US domestic medical device supply chains by investing money and resources in preventive measures, identifying potential shortfalls of devices and conducting ongoing surveillance and rapid interventions as needed.

“Funding for a permanent device shortages program at the FDA is critical to decrease or eliminate the risk of medical device supply chain shortages, and part of the agency’s overall investment in core FDA safety programs,” the agency states.

More data from medical device manufacturers

Although FDA has yet to publish specific components of the new program, one feature of the program that manufacturers should begin considering now pertains to “supply disruption notifications.”

Manufacturers of critical devices—PPE and ventilators, for example, in the case of the COVID-19 emergency—would be required to notify FDA if the potential for a shortage of such devices occurs. Such notifications would have to include device production volume data. Plus, manufacturers would have to implement and share supply chain-related risk management plans, as well as identify alternate device component suppliers and manufacturing sites that would come into play in the event of a supply shortage.

Although FDA has yet to formally lay out the RSCSPP or obtain authorization from the US Congress to launch the program, medical device manufacturers should be aware of these potential reporting requirements that for some firms may require substantial effort and internal resources to provide. Emergo by UL consultants will provide additional updates on the RSCSPP as they become available.

Learn more about US FDA medical device regulations at Emergo by UL:

• US FDA 510(k) consulting for medical device and IVD companies
• US FDA Emergency Use Authorization (EUA) registration for medical devices and IVDs
• Webinar: Medical device regulatory access during public health emergencies