Medical Device Flashcards
Federal Food, Drug, and Cosmetic Act - FD&C Act
- Also Medical Device definition was introduced. Checked only for adulteration and misbranding
FD&C Act as amended by the Food and Drug
Administration Modernization Act - FDAMA
1997
21 CFR 807
Establishment Registration and Device Listing, Premarket Notification - 510(k)
21 CFR 812
Investigational Device Exemptions - IDE
21 CFR 814
Premarket Approval - PMA
21 CFR 860
Medical Device Classification Procedures
Pure Food and Drugs Act
1906
Medical Device Amendments
- Safety and effectiveness;
regulations for establishment registration and device listing;
Good Manufacturing Practices (GMPs) for medical devices;
medical device reporting (MDR); and guidelines on policy, procedures and industry responsibilities for field corrections and removals
21 CFR 820
Quality System Regulation (QSR)
Intercenter Agreement (31 October 1991)
CBER has responsibility for devices related to blood and cellular products
Safe Medical Devices Act
1990
Medical Device Amendment
1992
Medical Device User Fee and Modernization Act - MDUFMA
2002
Food and Drug Administration Amendments Act - FDAAA
2007
Food and Drug Administration Safety and Innovation Act - FDASIA
2012
