- Source: Medical Device User Fee and Modernization Act
- Medical Device User Fee and Modernization Act
- Federal Food, Drug, and Cosmetic Act of 1938
- Health technology
- Sculptra
- History of the Food and Drug Administration
- Prescription Drug User Fee Act
- FDA Center for Devices and Radiological Health
- Verification and validation
- Food and Drug Administration Safety and Innovation Act
- Single use medical device reprocessing
The Medical Device User Fee and Modernization Act (MDUFA) authorizes the Center for Devices and Radiological Health (CDRH) to collect user fees from medical device manufacturers. It is reauthorized every 5 years.
In the years preceding enactment of MDUFMA, the FDA's medical device program suffered a long-term, significant loss of resources that undermined the program's capacity and performance.
History
User fees
References
External links
Official website, FDA