The organisation and the regulations of the US Food & Drug Administration (FDA) are frequently considered hard to comprehend. With regard to medical devices the CDRH runs a quite detailed website providing really interesting summaries as CDRHLearn. Surprisingly the site also offers "Tests" to review the learned subjects. Some Powerpoint presentations are also posted on the website, and, frequently also a video.
The following topics are offered as courses (selection):
and, also up-to-date (June 2011)
The "courses" planned for the future are also interesting. In addition to the topic "premarket approvals" it is also planned to issue something on CAPA (under the headline "Advanced Quality Systems"). We will keep you posted.
Conclusion: FDA's CDRHLearn website is really well structured and for that reason offers true assistance to better become familiar with medical devices.
Please also see the CDRH Learn Course List.
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)