Fda Medical Device Fees

Medical Device User Fees | FDA

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/medical-device-user-fees

Federal law authorizes FDA to charge a fee for medical device product review. These fees apply to Premarket Notifications (510 (k)s), Premarket Approval Applications (PMAs), Product Development ...

Medical Device User Fee Rates for Fiscal Year 2022

https://www.federalregister.gov/documents/2021/08/02/2021-16408/medical-device-user-fee-rates-for-fiscal-year-2022

Device Registration and Listing | FDA

https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing

For assistance with registration and listing status, please contact the CDRH Registration and Listing Help Desk at: Phone: 301-796-7400. Email: …

Who Must Register, List and Pay the Fee | FDA

https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee

Establishments that are involved in the production and distribution of medical devices intended for commercial distribution in the United States (U.S.) are required to register …

Payment Process | FDA - U.S. Food and Drug …

https://www.fda.gov/medical-devices/device-registration-and-listing/payment-process

Check made payable to Food and Drug Administration (must be in U.S. dollars and drawn on a U.S. Bank) Write the FDA post office box number ( PO Box 70961) on the check. …

FDA Announces New Medical Device User Fees for FY 2023

https://www.registrarcorp.com/fda-announces-new-medical-device-user-fees-for-fy-2023/

The U.S. Food and Drug Administration (FDA) has announced the Fiscal Year (FY) 2023 fees under the Medical Device User Fee Amendments (MDUFA). The fiscal …

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 …

Medical Device User Fee Amendments of 2017

https://www.fda.gov/media/165069/download

the FDA Amendments Act (MDUFA II), in 2012 with the Medical Device User Fee Amendments to the Food and Drug Administration Safety and Innovation Act (MDUFA …

FDA User Fee Programs | FDA - U.S. Food and Drug …

https://www.fda.gov/industry/fda-user-fee-programs

Complete Form FDA 3914 (User Fee Payment Transfer Request) to request a transfer of user fees paid to the FDA as directed by the Food, Drug, and Cosmetic Act …