The Medical Device Amendments Of 1976

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 … See more

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

Introduced concept of risk-based classifications for medical devices 1976: Medical Device Amendments to the FD&C Act Intended to provide reasonable assurance of the safety …

PMA Approvals | FDA - U.S. Food and Drug Administration

https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/pma-approvals

The Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act (the act) established three regulatory classes for medical devices. The …

Medical Device Regulation Act - Wikipedia

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

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

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

Jul 13, 2022

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 & Radiological Health Regulations Come …

https://www.fda.gov/about-fda/histories-product-regulation/medical-device-radiological-health-regulations-come-age

The 1976 amendments defined devices similarly to drugs, but noted that drugs cause a chemical reaction in the body, whereas devices do not. They called for all devices to be …

H.R.11124 - Medical Device Amendments 94th Congress …

https://www.congress.gov/bill/94th-congress/house-bill/11124

Describes such classification as follows: (1) Class I includes devices not purported to be for a use which is of substantial importance in supporting, sustaining, or preventing …

Legislative History of the Medical Device Amendments of …

https://www.ncbi.nlm.nih.gov/books/NBK209793/

The device legislation essentially applied the entire system of new-drug regulation to medical devices. Any device that was generally recognized as safe (GRAS) and generally recognized as effective (GRAE) was …

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 …