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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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