Medical Device User Fee and Modernization Act (MDUFMA)
- Allows for user fees which will allow the FDA to make significant improvements in the medical device review program.
- Establishment inspections may be conducted by accredited persons (third-parties), and establish new regulatory requirements for reprocessed single-use devices. FDAAA changes the medical device establishment registration requirements, although both foreign and domestic drug manufacturers still must register establishments.
Read more about this topic: Food And Drug Administration Amendments Act Of 2007
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