miércoles, 25 de febrero de 2015

FDA "CDRH Learn" Website Updated!

FDA's Center for Devices and Radiological Health's (CDRH’s) innovative multi-media industry education website, “CDRH Learn”, has recently been updated to better meet your regulatory educational needs. We’re excited to tell you about new modules we’ve added and some improvements that will help you better navigate the CDRH Learn website!

New Design/Layout and Major Category Headings
The categories and sections of CDRH Learn have been modified to be more intuitive to the topic areas. The major sections are:
  • "Start Here/The Basics!" - a great place to start and get an overview of the regulations
  • "How to Study and Market Your Device" - covers topics about clinical trials and marketing applications such as 510(k)s, de novos, and IDEs
  • "Postmarket Activities" - covers topics to help you maintain regulatory compliance after your medical device is legally marketed, such as quality systems, exporting, recalls and medical device reporting
  • "Unique Device Identification" - addresses the UDI program, an emerging policy that will affect all medical devices over the next few years
  • "Specialty Technical Topics" - covers a range of cross-cutting and specific policy topics, such as software and home use
  • "Radiation-Emitting Products" – includes information about regulations governing radiation-emitting and electronic products, including medical and non-medical products
  • "In Vitro Diagnostics" - addresses topics specific to the regulation of IVDs
  • "Industry Basics Workshop - November 4, 2014" - a complete recording of a 5-hour online workshop, including 5 separate regulatory presentations and live Q+A segment.

Updated Content
We recently completed a comprehensive review of existing modules. As a result, we updated old content and added some new modules. So the content that you'll find on CDRH Learn is now current and up-to-date. Check out our new modules that address topics you've requested!

CDRH Learn is now mobile friendly! You can download modules on your smart phone, tablet, or other portable device.   Now you can access educational modules any time, 24/7.

We look forward to continuing to work toward meeting your educational needs. Our web resources exist to help you navigate the medical device regulatory requirements. So don’t forget to consult our other resource, Device Advice, a comprehensive text-based website with over 1500 pages of information. As always, we welcome your feedback and suggestions!

Thank you,

Division of Industry and Consumer Education (DICE)
Center for Devices and Radiological Health
check out our DICE Homepage

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