To amend the Federal Food, Drug, and Cosmetic Act to provide for clarification of requirements for the remanufacturing of medical devices, and for other purposes.
Clarifying Remanufacturing to Protect Patient Safety Act of 2022
This bill specifies that entities that remanufacture medical devices in a manner that could change the performance or safety specifications or the intended use of the device must register with the Food and Drug Administration as producers of medical devices and comply with related requirements.
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