Home > Service > FDA 510K (Excluding Establishment Registration and Device Listing of the Product Covered by the Contract)
FDA 510K (Excluding Establishment Registration and Device Listing of the Product Covered by the Contract)

FDA, short for Food and Drug Administration, an international medical evaluation authority, was empowered by the United States Congress (the federal government) to serve as the highest law enforcement agency engaged in the regulation of food, drugs, medical devices, electromagnetic radiation emitting devices (ERED), vaccines, blood and biological products, animal food & feeds and veterinary products, cosmetics and tobacco products.

FDA regulates medical devices through the Center for Devices and Radiological Health (CDRH), which supervises medical device manufacturers, packers and distributors to conduct business activities under the premise of abiding by laws. Medical devices, ranging in nature and complexity from simple medical gloves to complex pacemakers, are all under FDA supervision. FDA divides medical devices into classes I, II and III, taking into account the intended purpose of the devices and their inherent risks (the higher the classification, the stricter the regulation).

Service process Official Fees Time Distribution Related Services

FDA (FY 2020)

Fee (USD)

Annual Establishment Registration Fee


510(k) premarket notification   submission


FY 2020: from 1 October 2019 to 30 September 2020


Review Content

FDA Official Timeframe (Day)

Review of 510(k) documents


Review of establishment registration




FDA 510K

FDA De Novo Request

FDA 513(g) Request

FDA PMA (Premarket Approval)

FDA MD Pre-Submission

FDA Device Listing

FDA Establishment Registration and Device Listing (510(k) exempt)

U.S. Medical Device Agent

Company Profile
Our services
Contact us
+49 30 5059 0627+49 30 8186 5124
Copyright © 2023 Osmunda Medical Device Service Group              粤ICP备05082100号-3