Medical Device Act 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 ...

Medical Device Regulation Act - Wikipedia

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

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 …

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. ...

An Introduction to FDA’s Regulation of Medical Devices

https://www.fda.gov/media/123602/download

• 1976: Medical Device Amendments to Federal Food, Drug, and Cosmetic Act (FD&C Act) • Subsequent Laws • 2002 - present: User Fee Programs

Medical Device & Radiological Health Regulations Come …

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

The long legal journey toward medical device regulation and radiological health protection--and ultimately the 1976 Medical Device Amendments--begins with the Pure Food and …

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 …

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 …

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 …

GovInfo | U.S. Government Publishing Office

https://www.govinfo.gov/content/pkg/STATUTE-90/pdf/STATUTE-90-Pg539.pdf

GovInfo | U.S. Government Publishing Office