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Safe Medical Device Amendments of 1990; Long title: An Act to amend the Federal Food, Drug, and Cosmetic Act to make improvements in the regulation of medical devices, and for other purposes. Enacted by: the 101st United States Congress: Effective: November 28, 1990: Citations; Public law: 101-629: Statutes at Large: 104 Stat. 4511 ...
Medical Device Amendments of 1976; Long title: An Act to amend the Federal Food, Drug, and Cosmetic Act to provide for the safety and effectiveness of medical devices intended for human use, and for other purposes. Enacted by: the 94th United States Congress: Effective: May 28, 1976: Citations; Public law: 94-295: Statutes at Large: 90 Stat ...
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 ...
The 2002 Medical Device User Fee and Modernization Act (MDUFA) first granted FDA the authority to collect user fees from industry to help the FDA improve efficiency, quality, and predictability of medical device submission reviews; the medical device user fee program has been reauthorized several times with the most recent in 2022.
Medical Device Regulation Act of 1976 in the United States This page was last edited on 23 September 2022, at 12:50 (UTC). Text is available under the Creative ...
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The 800 series are for medical devices: 803 Medical device reporting; 814 Premarket approval of medical devices [3] 820 et seq. Quality system regulations (analogous to cGMP, but structured like ISO) [4] 860 et seq. Listing of specific approved devices and how they are classified; The 900 series covers mammography quality requirements enforced ...
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