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Materials Available from FDA Public Webinar About the “510(k) Premarket Review Process” and the “Use of Science in Regulatory Decision Making” Draft Reports
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
I don’t see the materials on CDRH’s webpage? Where?
The link to the webinar on the website now links to the audiofile. http://fda.yorkcast.com/webcast/Viewer/?peid=8fed89730ec045e9add6b222f8686a45
We will make that more clear on the website.
Anyone having any connection with medical devices would know there is a need for scientific evaluation and the 510(K) Process.
I don’t under stand it… Can you give me more information? Great article!!!