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Recent Final Medical Device Guidance Documents | FDA

    https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/recent-final-medical-device-guidance-documents
    Jan 12, 2023

Medical Devices | FDA - U.S. Food and Drug Administration

    https://www.fda.gov/Medical-Devices
    Public Health Emergency Updates. Stay up to date as we continue to keep up our ongoing mission of protecting public health and spurring medical device innovation. "Our center …

Guidance Documents (Medical Devices and Radiation …

    https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products
    1 (800) 638-2041. (301) 796-7100. [email protected]. Information-Medical Devices / Radiation Products. Division of Industry and Consumer Education. CDRH-Center for …

Devices Guidances | FDA

    https://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/devices-guidances

    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 …

    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
      The following steps may be helpful when trying to determine if a product is regulated by the FDA as a medical device. Step 1: Determine if your product meets the …

    Guidance - MDCG endorsed documents and other guidance

      https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en
      Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices. April 2022. MDCG 2021-24 Search for available …

    HSA | Guidance documents for medical devices

      https://www.hsa.gov.sg/medical-devices/guidance-documents
      Guidance documents for medical devices. Here is the list of guidance documents with relevant forms and templates to help you meet the regulatory …

    MDR Guidance Documents - Medical Device Regulation

      https://www.medical-device-regulation.eu/mdr-guidance-documents/
      MDCG 2020-4 Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions EC …



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