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):

• An overview about the regulatory background
• "Authorisation aspects" (Premarket Notification Process - 510 (k))
• Clinical trials of medical devices
• Bioresearch Monitoring (BIMO; up-to-date from June 2011)
• An introduction to the software falling under CDRH regulations
• Information on 21 CFR 820 (Quality System Regulations)
• Information on recalls

and, also up-to-date (June 2011)

• News with regard to the Single Audit Programme (see also GMP-News from 1 December 2010)

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.

Author:
Sven Pommeranz
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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11/04/2012	PIC/S publishes Aide-Memoire on Inspection of Risk Management Systems