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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 Advice - Introduction to labeling requirements for medical devices, including advertising, over the counter, exemptions, in vitro diagnostics, investigational devices, quality system ...

Guidance on Medical Device Patient Labeling | FDA

    https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-medical-device-patient-labeling
    This guidance serves a dual purpose: (1) to assist manufacturers in their development, and (2) to assist Center reviewers in their review and evaluation of medical device patient …

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 …

eCFR :: 21 CFR Part 801 -- Labeling

    https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801
    (a) The appropriate FDA Center Director may grant an exception or alternative to any provision listed in paragraph (f) of this section and not explicitly required by statute, for …

Device Labeling Guidance #G91-1 (Blue Book Memo) | FDA

    https://www.fda.gov/regulatory-information/search-fda-guidance-documents/device-labeling-guidance-g91-1-blue-book-memo
    Regulations applicable to medical devices provide that the inclusion of any of the following representations in device labeling constitutes misbranding of the device: 21 CFR 801.6 - …

Medical Device Labeling - Food and Drug …

    https://www.fda.gov/media/94062/download
    Medical Device Labeling FDA Small Business Regulatory Education for Industry (REdI) Silver Spring, Maryland September 29, 2015 Eric Richardson, M.S. Branch Chief (Acting), …

FDA Label Search

    https://labels.fda.gov/
    The drug labels and other drug-specific information on this Web site represent the most recent drug listing information companies have submitted to the Food and Drug …



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