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Remanufacturing and Servicing Medical Devices | FDA

    https://www.fda.gov/medical-devices/quality-and-compliance-medical-devices/remanufacturing-and-servicing-medical-devices
    Draft GuidanceThe distinction between "remanufacturing" and "servicing" is important to under…Papers and Reports1. Servicing Discussion Paper: Strengthening Cybersecurity Practices A… See more

Product Returns and Replacements - Patient Services

    https://www.medtronic.com/us-en/patients/patient-services/product-returns-replacements.html
    I need to replace or return an external device (e.g., CareLink remote monitor, programmer, insulin pump, or new product) RETURNING AN EXPLANTED PRODUCT A device that …

Classify Your Medical Device | FDA

    https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device
    For Class III devices, a premarket approval application (PMA) will be required unless your device is a preamendments device (on the market prior to the passage of the medical …

Recalls, Corrections and Removals (Devices) | FDA

    https://www.fda.gov/medical-devices/postmarket-requirements-devices/recalls-corrections-and-removals-devices
    Overview. A recall is a method of removing or correcting products that are in violation of …

Overview of Medical Device Classification and …

    https://www.fda.gov/about-fda/cdrh-transparency/overview-medical-device-classification-and-reclassification
    Reclassification of Medical Devices Preamendments Devices A preamendments device is one that was in commercial distribution before May 28, 1976, the date the Medical Device …

How to Determine if Your Product is a Medical Device | FDA

    https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device
    Step 1: Determine if your product meets the definition of a medical device per Section 201 (h) of the Food, Drug & Cosmetic Act. Step 2: Determine if an appropriate …

Medical Device Accessories | FDA

    https://www.fda.gov/medical-devices/classify-your-medical-device/medical-device-accessories
    The UDI requirements apply to all medical devices per 21 CFR 801.20, including medical device accessories, unless an exception or alternative applies or was …

Medical Device Recalls | FDA

    https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls
    If you wish to find information on a recall, or a correction or removal action that has not yet been classified, you can search the Medical Device Recalls Database. Please …

What are Medical Devices? - News-Medical.net

    https://www.news-medical.net/health/What-are-Medical-Devices.aspx
    A medical device is any appliance, apparatus, software, material, or other articles, which may be used in isolation or combination (as defined by the manufacturer) …

Payment Credits for Replaced Medical Devices That …

    https://oig.hhs.gov/reports-and-publications/workplan/summary/wp-summary-0000085.asp
    Payment Credits for Replaced Medical Devices That Were Implanted Certain medical devices are implanted during inpatient or outpatient procedures. Such devices may …



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