Regulatory aspects of total product life cycle

Ethan D Hausman1, Sousan S Altaie

  • 1Division 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

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