FDA > CDRH > CDRH Learn
CDRH Learn
Welcome to CDRH Learn, FDA=92s Center for Devices and Radiological =
Health=20
(CDRH) Web page for industry education. CDRH is responsible for ensuring =
the=20
safety and effectiveness of medical devices and eliminating unnecessary =
human=20
exposure to man-made radiation from medical, occupational and consumer =
products.=20
We are committed to educating industry on the relevant policies and=20
regulations.
CDRH Learn is our latest innovative educational tool. It consists of =
a series=20
of training modules describing many aspects of medical device and =
radiological=20
health regulation, covering both premarket and postmarket issues. This =
tool is=20
intended to provide the medical device and radiological health industry =
with an=20
information resource that is comprehensive, interactive, and easily =
accessible.=20
Listed below are the courses CDRH currently offers. Additional online =
courses=20
are being developed and will be posted upon completion.
CDRH is in the process of developing post tests for each online =
course to=20
determine the effectiveness of the information. The tests will be posted =
as soon=20
as they are available.
Overview=20
of Regulatory Requirements: Medical Devices=20
Quality=20
System Regulation 21 CFR 820 Basic Introduction=20
Overview of the Premarket Notification Process =96 510(k)=20
510(k)=20
Overview=20
Slide=
=20
Presentation=20
(Post test coming soon)
Product=20
Codes Making the Connection=85
510(k)=20
Format Guidance, Including Standards Form, and Extensions/Clinical =
Trial=20
Form and 510(k)
Slide=20
Presentation=20
(Post test coming soon)
510(k)=20
Third Party Review=20
=93513(g)s=94=85=20
Including 513(g) User Fees=20
Overview of Radiological Health Requirements
The online training is accessible through the Internet by using:
standard Web browser=20
standard video/audio streaming player software (free)
To view the online video presentation: You will need =
Windows=20
Media Player 9.0 installed on your computer. You will also need:
Microsoft Windows 2000, Windows XP, or Macintosh OS X=20
Display resolution of 800 x 600 pixels or greater=20
Windows-compatible sound card=20
Microsoft Internet Explorer 6.0 SP1=20
Windows Media Player 9.0=20
Broadband Internet connection (256 Kbps & above)=20
Java Version 1.4.2 or later required for captioning support=20
Troubleshooting: If you have a pop-up blocker =
installed on your computer, the video windows may not open properly. =
Simply=20
disable the blocker while using this Web site. If the video does not =
play, it is=20
possible that your firewall is set up to block video/audio from coming =
through.=20
Contact your IT department for assistance and special configuration =
settings.=20
Disclosure:
The presenters are FDA/CDRH staff and therefore, as employees, have =
claimed=20
no interests, financial or otherwise, with medical device or =
radiation-emitting=20
products that may be shown in any of the presentations.
Updated November=20
21, 2008
CDRH Home Page | CDRH=20
A-Z Index | Contact CDRH =20
| Accessibility | =
DisclaimerFDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center=20
for Devices and Radiological Health / CDRH
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