Context: The US Food and Drug Administration (FDA) announced it will exercise authority over laboratory-developed tests (LDTs). Laboratory-developed tests have traditionally been developed and offered in laboratories as a service to patients and regulated under the Clinical Laboratory Improvement Amendments of 1988 (Clinical Laboratory Improvements Act). Laboratories now face potential dual regulatory oversight from both the Centers for Medicare and Medicaid Services (CMS) and the FDA. The College of American Pathologists (CAP) constructed a proposal to minimize redundancy of agency oversight and burden to laboratories. Modifications to the proposal continue while the laboratory community awaits release of the guidance documents that will stipulate FDA requirements.
Objective: To describe the historical context framing the entry of FDA into the oversight of LDTs and outline the CAP LDT Proposal in its current form.
Data sources: PubMed review of published literature; United States Constitution; and online information resources from the National Institutes of Health, FDA, and US Government.
Conclusion: The College of American Pathologists is a leader in laboratory quality and has unique insights into the benefits and risks to patients presented by LDTs. Continued dialog with officials from the FDA and CMS will promote public and private collaborative efforts to assure innovation of diagnostic testing, public information, and patient safety for clinical diagnostic testing.