Medical Device Makers Must Report When They Stop Making Stuff
Published Date: 1/7/2025
Notice
Summary
The FDA has released updated rules for medical device makers about telling the agency if they stop or pause making certain devices. This new guidance lists which devices need mandatory notifications and lets companies share supply problems anytime, even without a health emergency. These changes help keep important medical devices available and give manufacturers clear deadlines to avoid surprises.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Manufacturers Must Notify FDA for Listed Devices
Manufacturers of devices on the FDA’s finalized “506J Device List” must notify FDA in accordance with section 506J of the Federal Food, Drug, and Cosmetic Act when they permanently discontinue or interrupt manufacturing of those devices. The guidance announcing this requirement was published in the Federal Register on January 7, 2025 and the 506J Device List is available on FDA’s website.
Voluntary Supply Notices Allowed Anytime
The FDA clarifies that manufacturers may submit voluntary notifications about supply chain issues at any time, even if there is no declared public health emergency. This option is intended to help FDA learn about potential problems earlier and may help prevent or mitigate device shortages.
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