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Device Labeling | FDA - U.S. Food and Drug Administration

    https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling
    Guidance on Medical Device Patient Labeling - Final Guidance for Industry and FDA Staff (PDF - 333KB) Section 206 of the Medical Device User Fee and Modernization Act (MDUFMA) (New...

Guidance on Medical Device Patient Labeling | FDA

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

How to properly label a medical device according to the …

    https://mdrregulator.com/news/how-to-properly-label-a-medical-device-mdr-2017-745
    In order to correctly label the medical device, the manufacturer should provide the fallowing information on the packaging / label of the device: name or trade name of the product, an indication that the device is a …

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
    As appropriate, the labeling should state that the device (trade name) is "indicated" or "intended for use" (1) in the treatment, mitigation, prevention or diagnosis of a recognized …



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