Advertisement
News
Advertisement

FDA Issues New Guidance on Medical Device User Fee Refunds and Exceptions

Tue, 04/02/2013 - 1:44pm
Mass Device

The FDA outlines cases in which a manufacturer can expect a refund of the user fees paid for the FDA's review of a medical device.

FDA logo

The FDA issued new guidance this month detailing cases in which a medical device manufacturer may be eligible for a refund of the user fee paid for agency review.

The federal watchdog agency described user fee protocols for both 510k and premarket approval applications, laying out the general guidelines the FDA will follow in determining whether the applicant may be able to request a user fee refund.

Topics

Advertisement

Share this Story

X
You may login with either your assigned username or your e-mail address.
The password field is case sensitive.
Loading