1. Food and Drug Administration, Department of Health and Human Services. 21 CFR 809. Food and Drugs, Chapter I, Subchapter H, Medical Devices, In Vitro Diagnostic Products for Human Use. Final rule. [41 FR 6903, Feb. 13, 1976]
2. Health Care Financing Administration (now Centers for Medicare & Medicaid Services), Public Health Service. 42 CFR Parts 405, 410, 416–418, 440, 482–485, 488, 491, 493, and 494. Medicare, Medicaid, and CLIA programs; regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Final rule with comment period; 1992:7002–243.
3. Centers for Medicare & Medicaid Services, Centers for Disease Control and Prevention. 42 CFR Part 493. Medicare, Medicaid, and CLIA programs; laboratory requirements relating to quality systems and certain personnel qualifications. Final rule; 2003:3640–714.
4. Draft Guidance for Industry and FDA Staff. Commercially distributed in vitro diagnostic products labeled for research use only or investigational use only: frequently asked questions. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Biologics Evaluation and Research [Issued 1 June 2011] www.fda.gov/downloads/medicaldevices/deviceregulationandguidancedocuments/ucm071269.pdf . Accessed 27th Aug 2011.
5. Scott M, Nguyen D. Clinical laboratory compliance: something old something new. LabMedicine. 2009;40:428–35.