Medical Device Labeling Requirements

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 this chapter discuss ...

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 …

eCFR :: 21 CFR Part 801 -- Labeling

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801

Subpart B. Labeling Requirements for Unique Device Identification. 801.20 – 801.57. § 801.20. Label to bear a unique device identifier. § 801.30. General exceptions from the …

Quality System Regulation Labeling Requirements | FDA

https://www.fda.gov/medical-devices/device-labeling/quality-system-regulation-labeling-requirements