Medical Device Act Of 1976

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-based classification system ...

General Controls for Medical Devices | FDA

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

Medical Device Regulation Act - Wikipedia

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

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/

By Jeffrey K. Shapiro –. The Medical Device Amendments of 1976 (“MDA”), Pub. L. No. 94-295, 90 Stat. 539 (1976), are commonly described as the beginning of the …

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 …

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

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

Extends specified sections of such Act relating to labeling, inspection, and seizures to medical devices. Authorizes the Secretary to prohibit the introduction into interstate …

Safe Medical Devices Act: management guidance for …

https://pubmed.ncbi.nlm.nih.gov/10129209/

The Safe Medical Devices Act is an extension of the Medical Device Amendments of 1976, which imposed production, distribution, and sales rules on medical device manufacturers. …

Overview of the Safe Medical Devices Act of 1990

https://www.drugwatch.com/fda/safe-medical-device-act/

The Safe Medical Devices Act of 1990 was a critical step in the FDA’s longtime efforts to monitor the impact of faulty medical devices on public health. But …

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

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

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 …

Legislative History of the Medical Device …

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

Although it was not called this at the time, it was a risk-based statute that assigned devices to high-risk, medium-risk, and low-risk categories. In 1970–1976, the Senate Committee …