Medical Device Act Reporting

Medical Device Reporting (MDR): How to Report Medical …

https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems

Medical Device Reporting (MDR) is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to...

eCFR :: 21 CFR Part 803 -- Medical Device Reporting

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-803

You must submit a report to us, and a copy of this report to the manufacturer, as soon as practicable, but no later than 30 calendar days after the day that you receive or …

Medical Device Safety | FDA - U.S. Food and Drug …

https://www.fda.gov/medical-devices/medical-device-safety

Medical Device Safety The FDA monitors reports of adverse events and other …

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

eCFR :: 21 CFR Part 803 -- Medical Device Reporting

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-803?toc=1

eCFR :: 21 CFR Part 803 -- Medical Device Reporting The Electronic Code of Federal Regulations Title 21 Displaying title 21, up to date as of 2/14/2023. Title 21 was last …

CFR - Code of Federal Regulations Title 21 - Food and …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=803

§ 803.53 - If I am a manufacturer, in which circumstances must I submit a 5-day report? § 803.56 - If I am a manufacturer, in what circumstances must I submit a …

Safe Medical Devices Act: Reporting Requirements and …

https://www.omic.com/safe-medical-devices-act-reporting-requirements-and-risk-management-concerns/

The Safe Medical Devices Act of 1990 (SMDA) (Public Law 102-629) requires ambulatory surgery centers, hospitals, outpatient diagnostic centers and other user facilities to report …

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

Established several key postmarket requirements: registration of establishments and listing of devices with the FDA, Good Manufacturing Practices (GMPs), and reporting of …

What is Open Payments? | CMS

https://www.cms.gov/OpenPayments

Open Payments houses a publicly accessible database of payments that reporting entities, including drug and medical device companies, make to covered recipients like …