Safe Medical Device Amendments

Other expansions of FDA s authority include the Dmg Price Competition and Patent Term Restoration Act of 1984, commonly known as the 1984 Amendments or the Waxman-Hatch Act, which was passed to attain quicker marketing of safe, effective, and less expensive generic dmgs and the Safe Medical Device Amendments of 1990, which was passed to correct perceived weaknesses in the implementation of the 1976 Device Amendments. Congress further expanded FDA authority over nutrition labeling and health and nutrient content claims on food labels with the Nutrition Labeling and Education Act of 1990. 

Safe Medical Device Amendments, requiring more extensive testing of devices. 1992 Prescription Drug User Fee Act. Established the payment of fees for the filing of applications (e.g., IND, NDA, PLA, etc.)... 

Congress expanded FDA s authority in 1962 with the Dmg Amendments of 1962, which stipulated that, before a dmg could be marketed, it must be shown to be effective as well as safe. In 1976, Congress similarly expanded FDA s authority over medical devices with the Medical Device Amendments. 

The Safe Medical Devices Act of 1990, a major revision to the 1976 amendments, among other revised requirements provided two major mechanisms for bringing an IVD medical device to market premarket notification and premarket approval. The act is administered by the FDA s Center for Devices and Radiological Health, of which the Division of Clinical Laboratory Devices (DCLD) is a part. The premarket notification process is used for devices that can be classified... 

Medical devices were first made subject to FDA regulation under the FD C Act of 1938. At that time, the statute included no requirement for premarket testing or approval. Congress enacted the Medical Device Amendments of 19766 to require pre-market notification for all medical devices, and pre-market approval for some old and new devices for which there is no adequate assurance of safety and effectiveness. The 1976 Amendments established a broad new array of statutory requirements and enforcement provisions. This new regulatory approach was supplemented by the Safe Medical Devices Act of 1990 3 and further refined by the Medical Device Amendments of 1992,61 Food and Drug Administration Modernization Act of 1997,6 jj g Medical Devise User Fee and Modernization Act... 

On the national level, oversight is generally restricted to medical devices, and not on operational matters. Federal jurisdiction of medical devices falls under the purview of the Department of Health and Human Services, Public Health Service, Food and Drug Administration (FDA), Center for Devices and Radiological Health. Under federal law, medical devices are regulated under the Medical Device Amendments of 1976 and the Radiation Control for Health and Safety Act of 1968. Additional regulatory authorization is provided by the Safe Medical Devices Act of 1990, the Medical Device Amendments of 1992, the FDA Reform and Enhancement Act of 1996, and the Food and Drug Administration Modernization Act of 1997. ... 

In modern times, in 1970 the U.S. Congress passed the Occupational Safety and Health Act (OSHA), which is considered an important milestone in regard to health and safety in the United States. Two subsequent milestones specifically concerned with medical devices in the United States are the Safe Medical Device Act of 1990 and the Medical Device Amendments in 1976. 

Device Safety. The Medical Device Amendments of 1976 required manufacturers of medical devices to obtain EDA approval of their devices by demonstrating that they would be safe and effective for their designated uses. An abbreviated approval process allowed a manufacturer to avoid the requirements for full approval if EDA concluded that its device was substantially equivalent to an existing device that was either EDA-approved or in existence prior to 1976. 

The FDA of the U.S. Department of Health and Human Services (DHHS) administers the regulatory controls for the Food, Drug, and Cosmetic Act of 1906 and the 1976 and 1990 amendments, which provide approval for commercial distribution of safe and effective medical devices. The 1976 amendments directed the FDA to regulate medical devices under control levels that are necessary to ensure safety and effectiveness. In order to achieve this task, the Medical Device Law under the amendments required the FDA to issue regulations placing all medical devices on the market at that time into one of three regulatory classes ... 

Provides concise information on the safe and effective use of medicines, medical devices, and methods of diagnosis and treatment. Also provides notifications of recently approved new and changed medicines and amendments to the Interchangeable Multi-source Medicines list. Provided free to prescribers and pharmacists, and available on subscription. Published three to four times a year by Medsafe, Ministry of Health, Level 18, Grand Plimmer Tower, 2-6 Gilmer Terrace, PO Box 5013, Wellington, New Zealand. Copies of all articles are included on the Medsafe web site. 

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