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The interesting question it poses, as I suspect that broader implications have not been realised (with various consolidation and networks of labs) is about testing using non-CE marked devices being performed at one location on behalf of another, so it may impact on labs which are within a health institutions, as service may be provided by a different entity to the one receiving the service. Interesting times dj From: Clinical biochemistry discussion list [mailto:[log in to unmask]] On Behalf Of Hart, Tanya Sent: 04 August 2014 12:41 To: [log in to unmask] Subject: Re: FDA proposal on regulation of lab developed tests My impression is that the FDA have concerns about "alternate" testing at independent labs. For example they say: "The FDA is aware of faulty LDTs that could have led to: patients being over- or undertreated for heart disease; cancer patients being exposed to inappropriate therapies or not getting effective therapies; incorrect diagnosis of autism; unnecessary antibiotic treatments; and exposure to unnecessary, harmful treatments for certain diseases such as Lyme disease." http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm407296.htm So perhaps the more important UK parallel would be enforcement of the existing rules on CE marking which, as I understand it, ought to apply to labs that aren't part of health institutions. Tanya Dr Tanya Hart Clinical Biochemist Department of Clinical Biochemistry Poole and Royal Bournemouth Hospitals ________________________________ From: Clinical biochemistry discussion list [mailto:[log in to unmask]] On Behalf Of David James Sent: 04 August 2014 12:01 To: [log in to unmask]<mailto:[log in to unmask]> Subject: FDA proposal on regulation of lab developed tests For those interested, the FDA has just given notice about oversight/reporting of laboratory developed tests (link below) - parallel in UK is that it would bring tests currently given exemption (in-house provided to that health institution) under oversight..............see BIVDA audit of in house testing http://www.bivda.co.uk/Portals/0/Documents/Policy%20and%20Media/Inhouse%20audit%20Aug%2013.pdf http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/UCM407409.pdf dj This message contains confidential information and is intended only for the individual named. 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