What are FDA's requirements regarding medical devices? The FDA itself gives a partial answer to this good question. At the end of last year and at the beginning of this year, the FDA has been making an extensive update of its online training available on CDRH's (Center for Devices and Radiological Health) medical devices homepage. There, you can find courses about the regulatory basis requirements, the premarket notification process - 510(k) and medical devices clinical trials as well as recalls but also video and printable slide presentations. A separate chapter also deals with "GMP for Medical Devices" (21 CFR 820, QSR). Very courageous individuals can even pass a test at the end of the presentations.
For further information please see the CDRH Learn Course List.
Compiled by Sven Pommeranz
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)