Coronavirus Spurs FDA Plea for Stricter Oversight of Medtech Manufacturers

FDA chief Stephen Hahn yesterday called on Congress to require medtech manufacturers to notify the agency of impending device shortages or supply-chain disruptions.

The FDA does not have the same authorities for medical device shortages as it does for drugs and biological products, according to Hahn. Medtech manufacturers are under no legal obligation to notify the FDA of a potential shortage or to respond to agency requests about potential supply-chain disruption, he added.

The agency proposes:

• All medtech companies notify the it of an “anticipated meaningful interruption in the supply of an essential device.” The FDA defines essential devices as those that may be prone to potential shortage if there is a supply disruption.
• Requiring all essential device manufacturers to periodically update the FDA about the manufacturing capacity for the essential devices they produce.
• Authorizing the temporary importation of devices that it would otherwise exclude when the benefits of the device in mitigating a shortage outweigh the risks.

Source: https://www.massdevice.com/coronavirus-spurs-fda-plea-for-stricter-oversight-of-medtech-manufacturers/