FDA oversight of laboratory-developed tests: is it necessary, and how would it impact clinical laboratories?

In 2010 the US Food and Drug Administration (FDA) stated that it would issue guidance on its oversight of laboratory-developed tests (LDTs), and in July of that year the FDA held a public meeting to receive feedback on a risk-based application of LDT oversight (http:// www.fda.gov/MedicalDevices/NewsEvents/Workshops Conferences/ucm212830.htm). The FDA acknowledged that LDTs have been in existence since the Medical Device Amendments of 1976 and that historically they had exercised enforcement discretion with respect to oversight. In 2010, however, the FDA stated that the complexity and risk associated with newer LDTs were such that oversight was necessary and that the FDA has “the statutory authority to assure that devices, including LDTs, are safe and effective for their intended use.” Indeed, the FDA notice cites a 2008 report from the Secretary’s Advisory Committee on Genetics, Health and Society (SACGHS) that recommended that the FDA address genetic LDTs because of its experience in evaluating laboratory tests.