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- W4231973411 abstract "For the past nine years, the Office of Device Evaluation of the FDA's Center for Devices and Radiological Health has been working on the mammoth task of sorting all the medical devices that were on the market as of 1976 into three classes and regulating their use. According to Robert L. Sheridan, the office's associate director, about half the job is completed. The office has designated 16 medical disciplines and written final regulations for thousands of devices, from the simplest to the most complex, used in nine of those disciplines. Regulations have been proposed for the remaining seven. At the same time, the office's 190 employees—about 110 scientists and 80 administrative and secretarial staff—continue to process about 9,000 documents per year dealing with new devices. They review proposed clinical investigations and decide whether a new device can legally go to market. We produce paper here, Sheridan says. We're a manufacturing" @default.
- W4231973411 created "2022-05-12" @default.
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- W4231973411 date "1985-10-25" @default.
- W4231973411 modified "2023-09-27" @default.
- W4231973411 title "Medical devices sorted into classes, regulated" @default.
- W4231973411 doi "https://doi.org/10.1001/jama.254.16.2245" @default.
- W4231973411 hasPublicationYear "1985" @default.
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