Regulatory aspects of total product life cycle.
Total Product Life Cycle (TPLC) is a conceptual framework for assessing any product or service (medical or otherwise). This article will address how the Center for Devices and Radiological Health of the U.S. Food and Drug Administration utilizes TPLC in a regulatory paradigm. TPLC will help guide the regulation of market-driven evolution of medical devices and radiation-emitting products from conception, through pre-market development, to widespread market use, and finally to obsolescence and replacement by subsequent generations of products.
Hausman
Ethan D
ED
Division of Chemistry and Toxicology Devices, Office of In Vitro Diagnostic Device Evaluatoina nd Safety, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Rockville, Maryland 20850, USA. exh@cdrh.fda.gov
Altaie
Sousan S
SS
D000818:Animals; D001709:Biotechnology / Q000331:legislation & jurisprudence*; D006801:Humans; D008018:Life Cycle Stages; D040541:Marketing / Q000331:legislation & jurisprudence; D013673:Technology Assessment, Biomedical / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration