Cliff Posted July 11, 2011 Share Posted July 11, 2011 Hi, I understand the requirement to use FDA approved tests to screen blood products. What I wanted to know is, are we allowed to use those same screening tests for diagnostic testing? If you could provide links guidance documents (or point me in the right direction) that would be very helpful. Thank you. Link to comment Share on other sites More sharing options...
SMW Posted July 11, 2011 Share Posted July 11, 2011 Some you can, some you can't. It all depends on the claims made in the particular manufacturer's instructions for use. Link to comment Share on other sites More sharing options...
clmergen Posted July 11, 2011 Share Posted July 11, 2011 From a quick lecture I had in SBB school, donor screening tests are approved by a different process at the FDA than are diagnostic tests. It has to do with sensitivity vs specificity. So if I remember correctly, if a manufacturer submits to both processes and gets approved twice, then yes we could use it. But as SMW stated, it depends on the manufacturer. Link to comment Share on other sites More sharing options...
clmergen Posted July 11, 2011 Share Posted July 11, 2011 Here is a link http://www.fda.gov/combinationproducts/jurisdictionalinformation/ucm121175.htm Link to comment Share on other sites More sharing options...
Cliff Posted July 12, 2011 Author Share Posted July 12, 2011 Terrific info, thanks. I think I have what I need now. Link to comment Share on other sites More sharing options...
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