Medical Device Regulation Act

:* *Class II - Performance Standards* for devices considered as moderate risks for human use. ::Medical device has insufficient information to provide reasonable assurance of the safety and effectiveness of the device. Medical device cannot be classified as a class I device because the controls authorized are insufficient to provide reasonable assurance of the safety and effectiveness of the device. Medical device has sufficient information to establish a performance standard and it is necessary to establish a performance standard for the device. :* *Class III - Premarket Approval* for devices considered as high risks for human use. ::Medical device cannot be classified as a class I device because insufficient information exists to determine that the controls authorized are sufficient to provide reasonable assurance of the safety and effectiveness of the device. 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 of human health, or presents a potential unreasonable risk of illness or injury, is to be subject, premarket approval to provide reasonable assurance of its safety and effectiveness. **Classification Panels for Medical Devices** :* Classification panels are to determine which devices intended for human use should be subject to the requirements of *class I - general controls*, *class II - performance standards*, or *class III - premarket approval*. :* Classification panels are to provide notice to the manufacturers and importers of medical devices intended for human use. :* Manufacturers and importers are to prepare for the application of such requirements and to report medical devices intended for human use manufactured or imported by them. :* Panel appointments shall consist of members with adequately diversified expertise in such fields as biological and physical sciences, clinical and administrative medicine, engineering, and other related professions. Persons who are qualified by training and experience to evaluate the safety and effectiveness of medical devices or possess skills in the use of, experience in the development, manufacture, or utilization of such medical devices. :* No individual who is in the regular full-time employment of the United States and engaged in the administration of this Act may be a member of any medical device classification panel. ## References ## References 1. 94th U.S. Congress. (December 11, 1975). ["H.R.11124: Medical Device Amendments"](http://thomas.loc.gov/cgi-bin/bdquery/z?d094:HR11124:). *Library of Congress THOMAS*. 2. 94th U.S. Congress. (May 28, 1976). ["S.510: 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."](https://www.congress.gov/bill/94th-congress/senate-bill/510). 3. ["Gerald R. Ford: "Statement on Signing the Medical Device Amendments of 1976.," May 28, 1976"](http://www.presidency.ucsb.edu/ws/index.php?pid=6069). *University of California - Santa Barbara*. 4. Office of the Federal Register. ["Federal Food, Drug, and Cosmestic Act of June 25, 1938, Public Law 75-717, 52 Stat 1040"](https://research.archives.gov/description/299847). *U.S. National Archives and Records Administration*. 5. Rados, Carol. (January–February 2006). ["The Medical Device Amendments of 1976"](https://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/MedicalDeviceandRadiologicalHealthRegulationsComeofAge/). *U.S. Food and Drug Administration*. 6. (1994). "Surviving the Dalcon Shield IUD: Women v. The Pharmaceutical Industry". *Teachers College Press*. 7. Swann, Ph.D., John P. ["Regulating Cosmetics, Devices, and Veterinary Medicine After 1938"](https://www.fda.gov/AboutFDA/WhatWeDo/History/Origin/ucm055137.htm). *U.S. Food and Drug Administration*. ::callout[type=info title="Wikipedia Source"] This article was imported from [Wikipedia](https://en.wikipedia.org/wiki/Medical_Device_Regulation_Act) and is available under the [Creative Commons Attribution-ShareAlike 4.0 License](https://creativecommons.org/licenses/by-sa/4.0/). Content has been adapted to SurfDoc format. Original contributors can be found on the [article history page](https://en.wikipedia.org/wiki/Medical_Device_Regulation_Act?action=history). ::