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eCFR :: 21 CFR Part 801 -- Labeling
- https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801
- 801.20 – 801.57. § 801.20. Label to bear a unique device identifier. § 801.30. General exceptions from the requirement for the label of a device to bear a unique device identifier. § 801.35. Voluntary labeling of a device with a unique device identifier. § 801.40. Form …
Device Labeling | FDA - U.S. Food and Drug Administration
- https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling
- Labeling regulations pertaining to medical devices are found in the following Parts of Title 21 of the Code of Federal Regulations (CFR). General Device …
General Device Labeling Requirements | FDA
- https://www.fda.gov/medical-devices/device-labeling/general-device-labeling-requirements
- The general labeling requirements for medical devices are contained in 21 CFR Part 801. These regulations specify the minimum requirements for all devices. Later sections in …
eCFR :: 21 CFR 820.120 -- Device labeling.
- https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820/subpart-K/section-820.120
- Each manufacturer shall control labeling and packaging operations to prevent labeling mixups. The label and labeling used for each production unit, lot, or batch shall be …
CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=801
- The information on this page is current as of Jan 17, 2023. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). …
eCFR :: 21 CFR 801.150 -- Medical devices; processing, …
- https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-E/section-801.150
- Following sterilization, and until such time as it is established that the device is sterile and can be released from quarantine, each pallet, carton, or other designated unit is …
eCFR :: 21 CFR Part 201 -- Labeling
- https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-201
- Labeling of medical gas containers. Appendix A to Part 201 Examples of Graphic Enhancements Used by FDA : ... The Electronic Code of Federal Regulations (eCFR) is a …
Quality System Regulation Labeling Requirements | FDA
- https://www.fda.gov/medical-devices/device-labeling/quality-system-regulation-labeling-requirements
- Various sections of the QS regulation have an impact on labeling: Section 21 CFR 820.80 (b) requires the inspection and testing of incoming materials including labeling; and 21 …
eCFR :: 21 CFR Part 201 -- Labeling
- https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-201?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 …
Code of Federal Regulations (CFR) | FDA
- https://www.fda.gov/medical-devices/overview-device-regulation/code-federal-regulations-cfr
- Most of FDA's medical device and radiation-emitting product regulations are in Title 21 CFR Parts 800-1299. These final regulations codified in the CFR cover various aspects of …
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