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The 1990 Safe Medical Device law originated after an eight-year U.S. congressional inquiry of the Medical Device Amendments of 1976. The 1976 legislation deviated the clarification and proper evaluation of competitive or "substantial equivalence" medical devices. [4]
Medical device cannot be classified as a class II device because insufficient information exists for the establishment of a performance standard to provide reasonable assurance of its safety and effectiveness of the device. Medical device is to be for use in supporting or sustaining human life, of substantial importance in preventing impairment ...
A GAO follow-up study in 1989 concluded that despite full implementation of the Medical Device Reporting (MDR) regulation, serious shortcomings still existed. Under the Safe Medical Devices Act of 1990 (SMDA), device user facilities must report device-related deaths to the FDA and the manufacturer, if known. The facilities must also report ...
Medical devices first came under comprehensive regulation with the passage of the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C), [9] which replaced the earlier Pure Food and Drug Act of 1906. The FD&C allowed the FDA to perform factory inspections and prohibited misbranded marketing of cosmetic and therapeutic medical devices. [10]
Health technology is defined by the World Health Organization as the "application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures, and systems developed to solve a health problem and improve quality of lives". [1]
To establish a reference range, the Clinical and Laboratory Standards Institute (CLSI) recommends testing at least 120 patient samples. In contrast, for the verification of a reference range, it is recommended to use a total of 40 samples, 20 from healthy men and 20 from healthy women, and the results should be compared to the published reference range.
The practice of reusing medical devices labeled for only one use began in hospitals in the late 1970s. [8] After a thorough review by the U.S. FDA in 1999 and 2000, [8] the agency released a guidance document for reprocessed SUDs that began regulating the sale of these reprocessed devices on the market, [9] under the condition that third-party reprocessors would be treated as the manufacturer ...
Single-use medical devices include any medical equipment, instrument or apparatus having the ability to only be used once in a hospital or clinic and then disposed. The Food and Drug Administration defines this as any device entitled by its manufacturer that it is intended use is for one single patient and one procedure only. [ 1 ]