Although they do say:
"... the FDA's draft guidance provides for exemptions for tests applicable to rare diseases and for tests offered within health care facilities or health care systems when there is no FDA-approved test available."
I would say this is good news for consumers, who are increasingly exposed to suspect and misleading tests sold directly over the web or via 'alternative' practitioners.
Stuart
-----Original Message-----
From: Clinical biochemistry discussion list [mailto:[log in to unmask]] On Behalf Of Barth Julian (LEEDS TEACHING HOSPITALS NHS TRUST)
Sent: 06 January 2015 16:54
To: [log in to unmask]
Subject: FDA and in-house tests
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http://0-jama.jamanetwork.com.wam.leeds.ac.uk/article.aspx?articleid=2089188
For those of us who provide in-house testing, this is a disappointment.
If only all commercially available assays were good!
Julian
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