Safe Medical Device Act of

This act requires healthcare facilities to report serious or potentially serious device-related injuries or illness of patients and/or employees to the manufacturer of the device. The FDA wants to obtain important information on device problems. The act applies to all inpatient facilities, ambulatory 

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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... 

Stat. 4511 (1990) Flannery EJ. The Safe Medical Devices Act of 1990 an overview. Food Drug Cosmetic Law J 1991 46 129. 

Recent legislation in the U.S.A., the Safe Medical Devices Act of 1990, has increased the range of types of devices required to go through the premarket approval process rather than the premarket notification (510k) process. This may be indicative of future FDA activity in the devices sector along the lines seen with pharmaceutical products. 

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. ... 

Adverse Events. The Safe Medical Devices Act of 1990 included a provision by which both users and manufacturers (and distributors) of medical devices are required to report adverse patient events that may be related to a medical device. Manufacturers must report to the FDA if a device (a) may have caused or contributed to a death or serious injury, or (b) malfunctioned in such a way as would be likely to cause or contribute to a death or serious injury if the malfunction were to reoccur. Device users are required to notify the device manufacturer of reportable incidents, and must also notify the FDA in case of a device-related death. In addition, the FDA established a voluntary program for reporting device problems that may not have caused an untoward patient event, but which may have the potential for such an occurrence under altered circumstances. 

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. 

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 Act, providing additional authority to the FDA for regulation of medical devices. 

The Safe Medical Devices Act requires reporting of medical devices that probably caused the death, serious filness, or injury of a patient. Postmarket surveillance on permanently implanted devices required with methods for tracing and locating patients depending on such devices. FDA is authorized to recall device product. 

III. Use of prevalidated and standardized packages Because software used in the regulated pharmaceutical industries is classified as medical devices it is possible for a vendor of a system to register that package under the Safe Medical Devices Act. The registration process includes submission of Copyright 2003 Marcel Dekker, Inc. 

From a regulatory viewpoint, a computer system used in research or production of a pharmaceutical or biological product is regulated as a medical device under the Safe Medical Device Act. 

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.)... 

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 ... 

USA. The Federal Food, Drug, and Cosmetic (FD C) Act provides that foods, drugs, cosmetics, and some medical devices are adulterated if they contain color additives that have not been proved safe to the satisfaction of the Food and Drug Administration for the particular use. A color additive is a dye, pigment, or other substance, whether synthetic or derived from a vegetable, animal, mineral, or other source, which imparts a color when added or applied to a food, drug, cosmetic, or the human body. 

The Australian community expects that medicines and medical devices in the marketplace are safe, of high quality, and of a high standard comparable to other countries. It is governed by the Therapeutic Goods Act of 1989, which came into effect in February 1991, to provide a national framework for the regulation of therapeutic goods ensuring the quality, safety, and efficacy of medicines. 

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