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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
- Welcome to FDA's information about medical device approvals. The following information is available: Recently Approved Devices that include some of the newest medical technology available ...
2020 Device Approvals | FDA
- 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
- CDRH 2022 Annual Report. Accomplishments for 2022, including the Pandemic Response, MDUFA V, Device Innovation, over-the-counter (OTC) hearing aid final rule, and device …
Step 3: Pathway to Approval | FDA
- https://www.fda.gov/patients/device-development-process/step-3-pathway-approval
- The pathway to approval for a medical device depends on its risk classification. Device Application Process. Because there is so much variation in the classification of devices, …
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 …
Devices Approved in 2023 | FDA
- https://www.fda.gov/medical-devices/pma-approvals/devices-approved-2023
- This page lists all medical devices approved through the CDRH Premarket Approval process (PMA) in 2023. For access to the approval packages for PMA …
Medical devices | European Medicines Agency
- https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
- The Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746) changed the European legal …
Importing Medical Devices | FDA
- https://www.fda.gov/industry/importing-fda-regulated-products/importing-medical-devices
- Importing FDA medical device. Medical device classification, pre-market submission, medical device registration and listing, 510(k), PMA, medical device labeling
Medical devices - World Health Organization
- https://www.who.int/health-topics/medical-devices
- A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related …
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