title: FDA marketing claims, and the practitioner.
abstract: The Food and Drug Administration (FDA) is the federal agency that is tasked with regulating market entry for medical devices. The laws that govern this process are codified in the Federal Food Drug and Cosmetic Act (the Act) and the regulations are based on this law. The medical device amendments to the Act were instituted in 1976, instituting the methods for classification of medical devices and the format for the premarket review of devices. Information for practitioners on how medical devices come to market, what data are required, how specific claims are cleared, and how the practitioner can give input to the system are critical for the further development of safe and effective medical devices.
authors.affiliation: Center for Devices and Radiological Health, Office of Device Evaluation, Food and Drug Administration, Rockville, MD, USA.
authors.forename: Susan
authors.initials: S
authors.lastname: Runner
mesh_terms: D018795:Device Approval; D004869:Equipment Safety; D006801:Humans; D040541:Marketing / Q000331:legislation & jurisprudence; D011356:Product Labeling; D011358:Product Surveillance, Postmarketing; D014481:United States; D014486:United States Food and Drug Administration