1. In Vitro Diagnostics. U.S. Food and Drug Administration. Available from: https://www.fda.gov/medical-devices/products-and-medical-procedures/in-vitro-diagnostics.
2. Draft guidance for industry, Food and Drug Administration staff, and clinical laboratories, Framework for regulatory oversight of laboratory developed tests (LDTs). Food and Drug Administration. Center for Devices and Radiological Health. Rockville, MD, October 3, 2014.
3. Proposed rule: medical devices; laboratory developed tests;Food and Drug Administration,2023
4. Medical Device Amendments of 1976, PL 94-295, May 28, 1976, U. S. Statut. at Large 90 (1976) 539–583.
5. U.S. Senate, Committee on Labor and Public Welfare, Subcommittee on Health, Medical Device Amendments, Government Printing Office, Washington, 1973. Hearings on S. 2368, S. 1446, and S. 1337, September 14 and 17, 1973.