RAC Exam - Devices US Questions With Complete Answers!!

Regulations - interpret laws and describe how they will be enforced guidance document - used to convey FDA's current thinking or enforcement priorities - not legally binding Sherley Amendment - prohibited labeling medicines with false therapeutic claims intended to defraud the purchaser Pure Food and Drug Act of 1906 - prohibited misbranded and adulterated foods, drinks and drugs from entering interstate commerce FD&C Act - 1938 - repealed 1906 law and sherley amendment - manufacturers were required to provide scientific proof new drugs were safe for their intended use before being placed on the market; cosmetics and medical devices regulated; prohibited adding poisonous substances to food unless unavoidable or required in production; FDA given authority to bring federal court injunctions, product seizures, and criminal prosecutions Public Health Service Act of 1944 - gave FDA authority over biological products (vaccines and serums) Durham-Humphrey Amendment of 1951 - clarified what constituted a prescription vs over the counter drug - required "Caution" statement Food Additives Amendment of 1958 - established criteria for food to be considered adulterated, mislabeled or harmful Kefauver-Harris Amendment of 1962 - requires proof of safety and efficacy before a drug can be marketed in the USMedical Device Amendments of 1976 - established three classes of medical devices based on the necessary degree of control to ensure safety and efficacy, each requiring a different level of regulatory scrutiny; also made provisions for ER&L and GMP Orphan Drug Act of 1983 - provided 7 years of market exclusivity and incentives for development of orphan drugs for rare diseases Safe Medical Devices Act of 1990 - device user facilities must report device-related deaths and serious injuries to FDA and manufacturer defined medical device instituted device tracking Drug Price Competition and Patent Restoration Act of 1984 - (Hatch-Waxman Act) established process for approving drugs based on comparison to an already approved product Biologics Price Competition and Innovation Act of 2010 - established process for approving biosimilar products based on similarity to an FDA-approved biological product Prescription Drug User Fee Act - establishes collection of user fees from companies submitting applications for certain drug and biological products, annual fee for each establishment and each drug product marketed. Medical Device User Fee and Modernization Act - collect user fees from medical device companies submitting applications to FDA - subject to reauthorization every 5 years Food and Drug Administration Safety and Innovation Act - extended FDA's authority to collect user fees from generic drug and biologics industries FDAMA - provided additional authority for drug and biologic postmarketing studies, monitoring, requiring "notice of change" to modify device or study protocolscodified expedited review policy, clarified humanitarian device provisions, and allowed FDA to recognize other national or international standards directed FDA to take "least burdensome approach"