FDA Issues 8 Guidances on Device User Fees, MDUFA IV Goals & Pre-Submissions
By Michael Mezher -
Published 03 October 2017
The US Food and Drug Administration (FDA) has issued seven new or updated guidances offering advice to medical device makers on its user fee programs and how FDA and industry actions impact the performance goals set by the fourth iteration of the Medical Device User Fee Amendments (MDUFA IV).
Categories: News, US, FDA, Medical Devices, Submission and registration
Tags: Guidance, MDUFA IV, User Fees, FDA Review Clock, Pre-Submissions, 510(k), PMA, De Novo