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eCFR :: 21 CFR Part 803 -- Medical Device Reporting
- https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-803
- (a) This part establishes the requirements for medical device reporting for device user facilities, manufacturers, importers, and distributors. If you are a device user facility, you must report deaths and serious injuries that a device has or may have caused or …
eCFR :: 21 CFR Part 803 -- Medical Device Reporting
- https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-803?toc=1
- The Code of Federal Regulations (CFR) is the official legal print publication containing the codification of the general and permanent rules published in the Federal …
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
- In the Federal Register of December 26, 2017 ( 82 FR 60922 ), the FDA issued a notification outlining the FDA's proposal to grant an alternative under 21 CFR 803.19 to permit …
eCFR :: 21 CFR Part 806 -- Medical Devices; Reports of …
- https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-806
- ( 1) Actions taken by device manufacturers or importers to improve the performance or quality of a device but that do not reduce a risk to health posed by the device or remedy a …
Medical Device Reporting | FDA
- https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/medical-device-reporting
- The Medical Device Reporting (MDR) Regulation requires medical device manufacturers, device user facilities and importers to establish a system that ensures the prompt …
CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=803
- CFR - Code of Federal Regulations Title 21. FDA Home. Medical Devices. Databases. The information on this page is current as of Jan 17, 2023. For the most up-to …
21 CFR Part 803 - MEDICAL DEVICE REPORTING
- https://www.law.cornell.edu/cfr/text/21/part-803
- 21 CFR Part 803 - MEDICAL DEVICE REPORTING CFR prev | next Subpart A - General Provisions (§§ 803.1 - 803.19) Subpart B - Generally Applicable Requirements for …
eCFR :: 21 CFR Chapter I Subchapter H -- Medical Devices
- https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H
- The Code of Federal Regulations (CFR) is the official legal print publication containing the codification of the general and permanent rules published in the Federal Register by the …
Medical Device Reporting for Manufacturers | FDA
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-reporting-manufacturers
- Center for Devices and Radiological Health This guidance document describes and explains the Food and Drug Administration’s (FDA, we, us) current regulation that addresses …
eCFR :: 21 CFR Part 806 -- Medical Devices; Reports of …
- https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-806?toc=1
- eCFR :: 21 CFR Part 806 -- Medical Devices; Reports of Corrections and Removals eCFR The Electronic Code of Federal Regulations Title 21 Displaying title 21, up to date as of …
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