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FDA 513(g) Request

The 513(g) Request is a fast and effective way to obtain FDA information on product classification and applicable regulatory requirements, applicable to products whose classification is not clear or where existing classification is in doubt. The following information will be provided in FDA response: (1) FDA's assessment, based on the information submitted in the request, as to the generic type of device (e.g., classification regulation) that the requester's device appears to be within (if any); (2) the class of devices within that generic type (and if there is more than one class within that generic type, the particular class within which the requestor's device appears to fall); (3) whether a PMA, 510(k), or neither is required in order to market devices of the particular class within that generic type; (4) other requirements applicable to devices of the particular class within that generic type; (5) whether a guidance document has been issued regarding the exercise of enforcement discretion over the particular class of devices within that generic type; (6) whether additional FDA requirements may apply, such as those applicable to radiation-emitting products.

Service process Official Dees Time Distribution Related Services


FDA (FY 2019)

Fee (USD)

513(g) request for classification information


FY 2019: from 1 October 2018 to 30 September 2019

Review Content

FDA Official Timeframe (Day)

Review of 513(g) Request


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

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