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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
- (a) The regulations in this part implement section 519(e) of the Federal Food, Drug, and Cosmetic Act (the act), which provides that the Food and Drug Administration may require a manufacturer to adopt a method of tracking a class II or class III device, if the device …
Medical Device Tracking | FDA
- https://www.fda.gov/medical-devices/postmarket-requirements-devices/medical-device-tracking
- Device tracking is required for the useful life of the device. The types of devices subject to a tracking order may include any Class II or Class III device: the failure of which would...
eCFR :: 21 CFR Part 821 -- Medical Device Tracking …
- https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-821?toc=1
- Device tracking system and content requirements: manufacturer requirements. Subpart C. Additional Requirements and Responsibilities. 821.30. § 821.30. Tracking obligations …
CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=821
- § 821.25 - Device tracking system and content requirements: manufacturer requirements. Subpart C - Additional Requirements and Responsibilities …
eCFR :: 21 CFR 821.25 -- Device tracking system and …
- https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-821/subpart-B/section-821.25
- § 821.25 Device tracking system and content requirements: manufacturer requirements. ( a) A manufacturer of a tracked device shall adopt a method of tracking for each such …
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 21 - …
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 …
CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=821&showFR=1
- (a) The regulations in this part implement section 519(e) of the Federal Food, Drug, and Cosmetic Act (the act), which provides that the Food and Drug Administration …
CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=821.30
- Sec. 821.30 Tracking obligations of persons other than device manufacturers: distributor requirements. (a) A distributor, final distributor, or multiple …
eCFR :: 21 CFR 821.20 -- Devices subject to tracking.
- https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-821/subpart-B/section-821.20
- Table of Contents eCFR Content § 821.20 Devices subject to tracking. ( a) A manufacturer of any class II or class III device that fits within one of the three criteria within § 821.1 (a) …
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