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User fee refund guidance

This article was originally published in The Gray Sheet

Executive Summary

Manufacturers will receive a check within 30 days after FDA decides a user fee refund is warranted, according to a 1CBER/CDRH guidance dated Nov. 17 and posted Nov. 24. The document, entitled "Resolution of Disputes Concerning Payment or Refund of Medical Device User Fees Under MDUFMA," details key considerations and advises preferred methods for pursuing various types of user fee appeals. The guidance notes that "in most instances, FDA believes disputes...are best resolved through a request for internal review through the supervisory chain" rather than more formal actions such as a citizen's petition or public hearing...
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