Medical Device Amendments 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

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 and...

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 …

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

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. …

Medical Device Reporting Regulation History | FDA

https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/medical-device-reporting-regulation-history

The statutory authority for the MDR regulation is section 519 (a) of the FD&C Act as amended by the Safe Medical Devices Act (SMDA) of 1990. The SMDA requires user …

Federal Register :: Medical Devices; Technical …

https://www.federalregister.gov/documents/2021/04/01/2021-06681/medical-devices-technical-amendments

ACTION: Final rule; technical amendments. SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is amending its medical device regulations to …

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 …

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 Medical Device Amendments of 1976 (“MDA”), Pub. L. No. 94-295, 90 Stat. 539 (1976), are commonly described as the beginning of the modern era of device …

Medical Device User Fee Amendments of 2017

https://www.fda.gov/media/165069/download

The Medical Device User Fee and Modernization Act (MDUFMA) was a law passed by ... III), and in 2017 with the Medical Device User Fee Amendments to the FDA …