The U.S. FDA’s Center for Devices and Radiological Health (CDRH) has issued a guidance explaining how medical device manufacturers are required to notify it of equipment shortages during the COVID-19 pandemic—a notable change.
Unlike drugmakers, device makers are not typically required to report shortages or discontinuances of their products to FDA; however, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) added new shortage reporting requirements for device makers. Specifically, Section 3121 of the CARES Act amends the Federal Food, Drug, and Cosmetic Act to require device makers to notify FDA of supply interruptions or permanent discontinuations for critical devices used during a declared public health emergency or devices for which information about shortages is deemed necessary by FDA.
Manufacturers are required to provide notice at least six months ahead of the discontinuance or interruption, or as soon as practicable if providing the notice within six months is not possible.
In its guidance, FDA calls on device makers to voluntarily provide additional details beyond the requirements of the CARES Act “to better ensure FDA has the specific information it needs to help prevent or mitigate shortages during the COVID-19 public health emergency.”
Read the full article on Regulatory Focus.