Fda Medical Device Annual Report

CDRH 2021 Annual Report | FDA - U.S. Food and Drug …

https://www.fda.gov/about-fda/cdrh-reports/cdrh-2021-annual-report

To highlight this work, CDRH released its 2021 Annual Report, which outlines the Center's programmatic accomplishments through December 2021, including the COVID-19 …

CDRH 2022 Annual Report | FDA

https://www.fda.gov/about-fda/cdrh-reports/cdrh-2022-annual-report

The FDA’s Center for Devices and Radiological Health (CDRH) released its 2022 Annual Report to highlight the Center’s programmatic accomplishments through …

Annual Reports for Approved Premarket Approval …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/annual-reports-approved-premarket-approval-applications-pma

This guidance document describes the information required to be submitted in annual reports under 21 CFR 814.84 (b), additional information requirements that may be …

Instructions for Completing the Medical Device Reporting …

https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/instructions-completing-medical-device-reporting-annual-user-facility-report-form-fda3419

Instructions for Completing the Medical Device Reporting Annual User Facility Report, Form FDA 3419 Under 21 CFR Part 803, the MDR regulation requires that user facilities …

PMA Postapproval Requirements | FDA

https://www.fda.gov/medical-devices/premarket-approval-pma/pma-postapproval-requirements

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

FDA Guidance: Medical Device Reporting for User Facilities (PDF Only) (PDF - 313KB) For Questions about Medical Device Reporting, including interpretation of MDR policy: Call: …

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=803.33

You must submit your annual report to FDA, CDRH, Medical Device Reporting, P.O. Box 3002, Rockville, MD 20847-3002. Your annual report must include: …

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

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

If you are a device user facility, you must report deaths and serious injuries that a device has or may have caused or contributed to, establish and maintain adverse event files, …

Mandatory Reporting Requirements: Manufacturers, …

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

The Medical Device Reporting (MDR) regulation ( 21 CFR Part 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report …

IDE Reports | FDA - U.S. Food and Drug Administration

https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-reports

Every six months the sponsor must submit to FDA a current list of the names and addresses of all investigators participating in a significant risk device investigation. [21 CFR 812.150 …