Why You Should Attend: While a few clinical laboratories have cleared their tests through 510(k), the assertion of jurisdiction over LDTs by FDA has not been welcomed by most clinical laboratories, and has yet to be tested in the courts. This 1 hour session will explore the reasons FDA has for claiming such jurisdiction, and the objections to FDAs' position articulated by the clinical laboratory community, and others.
It will describe the current situation, which has FDA withdrawing their draft guidance, and Congress, in a 2013 law, calling for review of any new LDT guidance developed by FDA, prior to its issuance. Will FDA wait until this requirement sunsets in 2017? Presently, no new guidance appears to be on the books for 2014. Will FDA attempt to 'get around' the requirement by issuing guidance under a different name? This talk will describe the reasons for FDAs concern, the legal arguments pro and con FDAs assertion of jurisdiction, the position of IVD manufacturers of competitive products, the situation today, and some possible outcomes.
Areas Covered in the Session
Definition of medical device, (21 USC 321(h)) and how it has been interpreted by FDA and the courts
'Enforcement Discretion' and how it has been applied to LDT regulation
Extent of CLIA '88 authority over LDT performance
Role of US Congress in answering the question of FDA authority
International (EU) approach to LDTs