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Device Labeling | FDA - U.S. Food and Drug Administration
- https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling
- Device Labeling Introduction to Medical Device Labeling Label vs. Labeling The U.S. Food and Drug Administration (FDA) develops and administers regulations under authority granted by...
Labeling - Regulatory Requirements for Medical Devices …
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/labeling-regulatory-requirements-medical-devices-fda-89-4203
- This publication explains label and labeling regulations and requirements for medical devices. The Food and Drug Administration has many labeling-related requirements to …
Labeling Requirements for Specific Devices | FDA
- https://www.fda.gov/medical-devices/general-device-labeling-requirements/labeling-requirements-specific-devices
- Labeling Requirements for Specific Devices | FDA Labeling Requirements for Specific Devices (21 CFR 801.405 to 801.437) Certain devices require specific labeling which …
eCFR :: 21 CFR Part 801 -- Labeling
- https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801
- ( 1) A device identifier - a mandatory, fixed portion of a UDI that identifies the specific version or model of a device and the labeler of that device; and ( 2) A production …
Guidance on Medical Device Patient Labeling | FDA
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-medical-device-patient-labeling
- When translating the professional label into lay language, take care to ensure that it does not alter the intent of the indications, contraindications, warnings and precautions, or …
CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=801&showFR=1
- Sec. 801.15 Medical devices; prominence of required label statements; use of symbols in labeling. (a) A word, statement, or other information required by or under …
Labeling Requirements - Misbranding | FDA
- https://www.fda.gov/medical-devices/general-device-labeling-requirements/labeling-requirements-misbranding
- The FDA Modernization Act of 1997 (FDAMA) repealed the restriction in Section 301 (l) of the FFDCA, which prohibited reference to FDA approval in the labeling or advertising of …
CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=801.18
- Whenever the label of a medical device includes a printed expiration date, date of manufacture, or any other date intended to be brought to the attention of the user …
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