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Device Approvals, Denials and Clearances | FDA

    https://www.fda.gov/medical-devices/products-and-medical-procedures/device-approvals-denials-and-clearances
    A PMA is an application submitted to FDA to request approval to market. Unlike premarket notification, PMA approval is to be based on a determination by FDA that the PMA contains sufficient...

2021 Device Approvals | FDA - U.S. Food and Drug …

    https://www.fda.gov/medical-devices/recently-approved-devices/2021-device-approvals
    Aug 1, 2022

2020 Device Approvals | FDA - U.S. Food and Drug …

    https://www.fda.gov/medical-devices/recently-approved-devices/2020-device-approvals
    Jan 14, 2022

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

    https://www.fda.gov/Medical-Devices
    Approvals and clearances, information on medical devices by type Digital Health Center of Excellence Cybersecurity, mobile medical apps, wireless medical devices, AI/ML in …

2021 Device Approvals | FDA - U.S. Food and Drug …

    https://cacmap.fda.gov/medical-devices/recently-approved-devices/2021-device-approvals
    2021 Device Approvals | FDA 2021 Device Approvals The products listed in this section include some of the newest medical technology from the year 2021. The …

Medical Device Databases | FDA

    https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases
    Apr 6, 2022

Premarket Approval (PMA) | FDA

    https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-approval-pma
    The regulation governing premarket approval is located in Title 21 Code of Federal Regulations (CFR) Part 814, Premarket Approval of Medical Devices. A Class …

How to Get FDA Approval for Medical …

    https://www.perforce.com/blog/alm/how-get-fda-approval-medical-devices
    How to Get FDA Approval for Medical Devices 1. Know Your Device’s Classification. You should know your device’s classification before the development …

Devices Approved in 2020 | FDA

    https://cacmap.fda.gov/medical-devices/pma-approvals/devices-approved-2020
    This page lists all medical devices approved through the CDRH Premarket Approval process (PMA) in 2020. For access to the approval packages for PMA originals and …



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