title: Introduction to the Food and Drug Administration (FDA) regulatory process.
abstract: FDA oversight of medical devices, including in vitro diagnostic devices (IVDs or laboratory tests), in the United States was a direct result of the passage of the Medical Device Amendments of 1976. This law introduced a series of general controls for medical devices including registration and listing, requirements for production using good manufacturing practices, and requirements for post-market reporting of device failures. This produced for the first time a menu of laboratory tests on the market, a system to ensure these were produced consistently over time, and a mechanism for FDA to identify problems with device use and to work with companies to ensure corrective action. This law also introduced the requirement for premarket review of new versions of old devices and of fundamentally new medical devices.
authors.affiliation: Office of In Vitro Diagnostic Device Evaluation and Safety, Food and Drug Administration, Rockville, MD, USA. jospeh.hackett@fda.hhs.gov
authors.forename: Joseph L
authors.initials: JL
authors.lastname: Hackett
authors.forename: Steven I
authors.initials: SI
authors.lastname: Gutman
mesh_terms: D000818:Animals; D015415:Biomarkers; D019411:Clinical Laboratory Techniques / Q000592:standards; D018795:Device Approval; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000592:standards; D020543:Proteome; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015415:Biomarkers; D020543:Proteome