Safe Medical Device act

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... 

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. 

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. 

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. 

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. 

Medical Device Incident Reporting under the Safe Medical Devices Act (SMDA)... 

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. 

For those readers not familiar with the premarket requirements for medical devices it is generally, but not always, true that a Class I device may be marketed without prior FDA clearance. A Class II device typically requires prior FDA clearance, known as a 510(k). This is usually true as long as the device can be shown to be substantially equivalent to a device previously cleared by FDA for the same indicated use, or for which there is a preamendment device with similarities. The requirement to continuously compare a new product to one on the market in 1976 was modified in 1990 with the Safe Medical Devices Act (SMDA). The regulations have been modified to focus on whether devices are either considered to be safe and thus manageable with special controls , or whether their safety might be an issue if certain unanticipated risk factors have evolved with expanded use. For this reason it is imperative to conduct an early regulatory assessment for any new product, no matter how similar it may seem to an existing product. 

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