BIOE-225 Lecture Notes - Lecture 1: Toothpaste, Sunscreen, Federal Register
27 Aug 2018
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Fda: oversees, food (except meat & poultry) Other worldwide agencies: europe: directorate general for health and consumers; medical devices sector of european. Fda organization: office of the commissioner, office of foods and veterinary medicine, office of global regulatory operations and policy, office of medical products & tobacco, office of operations. Intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Intended to affect the structure or any function of the body (food is excluded: drug, recognized by an official pharmacopoeia or formulary. Intended for use as a component of a medicine but not a device or a component, part or accessory of a device. Includes biological products - generally covered by same laws & regulations, but there are differences in manufacturing processes. Potentially pose a significant risk of illness/injury to patient. Requires pre-market approval (pma) before device can be sold. Includes the submission of clinical data to support claims: class ii.
