Medical Device Amendments 1976 Provisions

General Controls for Medical Devices | FDA

https://www.fda.gov/medical-devices/regulatory-controls/general-controls-medical-devices

General Controls are the basic provisions (authorities) of the May 28, 1976 Medical Device Amendments (hereafter referred to as the Amendments) to the Food, Drug and Cosmetic Act, that provide the FDA with the means of regulating devices to ensure their safety and effectiveness. The General Controls in the Ame… See more

Medical Device Regulation Act - Wikipedia

https://en.wikipedia.org/wiki/Medical_Device_Regulation_Act

A History of Medical Device Regulation and Oversight in …

https://www.fda.gov/medical-devices/overview-device-regulation/history-medical-device-regulation-oversight-united-states

1976: Medical Device Amendments to the FD&C Act Intended to provide reasonable assurance of the safety and effectiveness of medical devices Created a three-class, risk …

The Medical Device Amendments of 1976 | Medicolegal …

https://www.cambridge.org/core/journals/medicolegal-news/article/medical-device-amendments-of-1976/31F49F8FF2658795113F8D9432291BA1

On May 28 1976 President Ford signed the Medical Device Amendments of 1976 (Amendments) to the Federal Food Drug and Cosmetic Act (FDCA) which …

The 1976 Medical Device Amendments: A Step in …

https://www.jstor.org/stable/26658558

The Medical Device Amendments were passed in 1976 to fill what was widely viewed as a great regulatory void. Unlike drugs, the FDA prior to 1976 could not review medical …

Text of S. 510 (94th): Medical Device Amendments …

https://www.govtrack.us/congress/bills/94/s510/text

The Title 21 amendments were signed into law on May 28, 1976 by the 38th President of the United States Gerald R. Ford. The U.S. legislation enacted in 1976 …

TOPN: Medical Device Amendments of 1976 | US Law

https://www.law.cornell.edu/topn/medical_device_amendments_of_1976

In theory, any law -- or individual provisions within any law -- passed by Congress should be classifiable into one or more slots in the framework of the Code. On the other hand, …

The Medical Device Amendments of 1976: The Statute That Went …

https://www.thefdalawblog.com/2013/06/the-medical-device-amendments-of-1976-the-statute-that-went-awry/

The MDA decreed that FDA would review all types of medical devices existing in 1976 and by regulation place them in Class I, II or III. See 90 Stat. 540-41. Class I …

Medical Device Amendments (1976 - S. 510) - GovTrack.us

https://www.govtrack.us/congress/bills/94/s510

The Medical Device Regulation Act or Medical Device Amendments of 1976 was introduced by the 94th Congress of the United States. Congressman Paul G. Rogers …

Medical Device Amendments of 1976 - OUP Academic

https://academic.oup.com/ajhp/article/33/12/1308/5213116

The Medical Device Amendments of 1976 are discussed with particular reference to the history of device regulation, classification of devices, performance …