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eCFR :: 21 CFR Part 821 -- Medical Device Tracking …
- https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-821
- Effective tracking of devices from the manufacturing facility, through the distributor network (including distributors, retailers, rental firms and other commercial enterprises, device …
Medical Device Tracking | FDA
- https://www.fda.gov/medical-devices/postmarket-requirements-devices/medical-device-tracking
- Please note that 21 CFR 821 does not contain the current list of devices to be tracked. The list may be found in the guidance document referenced above and at the bottom of this …
eCFR :: 21 CFR Part 821 -- Medical Device Tracking …
- https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-821?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 Register by the …
21 CFR Part 821 - MEDICAL DEVICE TRACKING …
- https://www.law.cornell.edu/cfr/text/21/part-821
- 21 CFR Part 821 - MEDICAL DEVICE TRACKING REQUIREMENTS | CFR | US Law | LII / Legal Information Institute. LII. Electronic Code of Federal Regulations (e-CFR) Title …
CAPA Medical Device Tracking | FDA
- https://www.fda.gov/capa-medical-device-tracking
- Ask the Management Representative (or designee) whether the firm manufactures or imports any device subject to the Medical Device Tracking Regulation (21 CFR Part …
CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=821&showFR=1
- (c) A manufacturer of a tracked device shall establish a written standard operating procedure for the collection, maintenance, and auditing of the data specified in …
CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=821
- § 821.4 - Imported devices. Subpart B - Tracking Requirements § 821.20 - Devices subject to tracking. § 821.25 - Device tracking system and content …
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 manufacturer or importer, you must report deaths and serious injuries that your device has or may have caused or contributed to, you must report certain device …
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 …
eCFR :: 21 CFR 821.30 -- Tracking obligations of …
- https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-821/subpart-C/section-821.30
- § 821.30 Tracking obligations of persons other than device manufacturers: distributor requirements. ( a) A distributor, final distributor, or multiple distributor of any tracked …
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