FDA Courses and Tests now available online
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)
Related GMP News
25.06.2025Is Knowledge Management a Part of the Pharmaceutical Quality System?
11.06.2025Swissmedic differentiates GMP Scope for Manufacturing and Preparation for Administration
28.05.2025A View on the EU Critical Medicines Act to secure Pharma Supply Chains
20.05.2025Summary Data on Registration and Listing of Cosmetic Facilities and Products
07.05.2025FDA is extending its Quality Management Maturity Programme
30.04.2025FDA Warning Letter on missing Audit Trails and Raw Data Review