Home > Transparency Posts > Materials Available from FDA Public Webinar About the “510(k) Premarket Review Process” and the “Use of Science in Regulatory Decision Making” Draft Reports

Materials Available from FDA Public Webinar About the “510(k) Premarket Review Process” and the “Use of Science in Regulatory Decision Making” Draft Reports

September 22, 2010 Leave a comment Go to comments

Did you miss the FDA webinar discussion on the draft reports about the 510(k) process and the use of science in regulatory decisions?  

The webinar was discussed in a August 26, 2010 blog post.  An audiofile of the discussion, along with the background materials,  is available on the CDRH website.  You can listen to the discussion here

FDA is soliciting comments from the public on the draft reports via www.regulations.gov, docket number FDA-2010-N-0348, until October 4, 2010.

Afia Asamoah, Transparency Initiative Coordinator

  1. Jill
    September 23, 2010 at 2:27 pm

    I don’t see the materials on CDRH’s webpage? Where?

  2. January 28, 2011 at 4:30 pm

    Anyone having any connection with medical devices would know there is a need for scientific evaluation and the 510(K) Process.

  3. abiti da cerimonia uomo
    March 14, 2012 at 4:50 pm

    I don’t under stand it… Can you give me more information? Great article!!!

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