FDA Oversight of Laboratory-Developed Tests: Is It Necessary, and How Would It Impact Clinical Laboratories?

Abstract

In 2010 the US Food and Drug Administration (FDA)7 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/WorkshopsConferences/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. Changes in the LDT environment that have prompted the FDA to consider oversight include the increasing complexity of genetic and other ‘omics testing and the increasing number of diseases that can be diagnosed, monitored, or treated on the basis of LDT results. Because of this state of affairs, the FDA stated that the risk associated with LDTs is far greater today than in the past. Other reasons for oversight include the movement of LDTs from local hospital-based laboratories to national reference laboratories, and the existence of LDTs for analytes that currently have FDA-cleared tests in the marketplace. In addition, the FDA cites a change in business models for providing LDTs, in which corporations, instead of local hospitals and local pathologists, are responsible for providing LDTs for large numbers of patients all over the country. The clinical laboratory industry has expressed concern that FDA oversight of LDTs will be …