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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 Software as a...

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

Recently-Approved Devices | FDA

    https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/recently-approved-devices
    Humanitarian Device Exemptions (HDE): Listing of devices that have been approved to treat or diagnose a disease or condition that affects fewer than 4,000 individuals in the …

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 …

Devices Approved in 2023 | FDA

    https://www.fda.gov/medical-devices/pma-approvals/devices-approved-2023
    Devices Approved in 2023 Devices Approved in 2023 Share Tweet Linkedin Email Print This page lists all medical devices approved through the CDRH …

A Breakdown of New FDA Approved Medical Devices in …

    https://www.goodrx.com/classes/medical-supplies-and-devices/fda-approved-devices-2021
    The FDA’s Center for Devices and Radiological Health (CDRH) is responsible for reviewing new submissions for medical devices. The CRDH approved or …

Recognized Consensus Standards - Food and Drug …

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm
    Databases This database provides the most up-to-date list of voluntary consensus standards to which FDA will accept a Declaration of Conformity. After FDA …



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