USFDA Guidance: Four Finalized User Fees and Refunds related Medical Devices Guidelines

USFDA's Center for Devices and Radiological Health and Center for Biologics Evaluation and Research finalized and released four Medical Devices Guidelines yesterday (05 October 2022).

1. Guidance on: User Fees for 513(g) Requests for Information

A 513(g) request is an opportunity for medical device manufacturers to obtain information from the FDA about the classification and regulatory requirements of a product.

The aim of this guidance document is to assist FDA staff and regulated industries in understanding 513(g) fees.

Guidance on: User Fees and Refunds

According to the Medical Device User Fee Amendments of 2022 (MDUFA V), FDA can collect user fees for reviewing premarket submissions received on or after October 1, 2022, including premarket notifications (510(k)s), for Premarket Approval Applications and Device Biologics License Applications, De Novo Classification Requests.

2. For (510(k)s):

This guidance document covers:

(1) the types of 510(k)s that require user fees,

(2) exceptions to user fees, and

(3) actions that may result in refunds of user fees.

3. For Premarket Approval Applications and Device Biologics License Applications

This guidance document covers:

(1) the types of PMAs and BLAs subject to device user fees;

(2) exceptions to user fees; and

(3) the actions that may result in refunds of user fees that have been paid.

4. For De Novo Classification Requests

This guidance document covers:

(1) the types of De Novo requests are subject to user fees;

(2) exceptions to user fees; and

(3) the actions that may result in refunds of user fees that have been paid.