US FDA Updates Guidance on Feedback Mechanisms for Medical Device Registrants

All current and new FDA avenues for applicants seeking agency feedback during their registration processes are now referred to as “Q-Subs” for more efficient agency tracking, and include the following methods:

Q-Sub TypeMeeting as Feedback Method?Timeframe for Meeting from Receipt of Submission
Pre-SubmissionUpon request75 – 90 days
Informational MeetingYes90 days
Study Risk DeterminationNoN/A
Agreement MeetingYes30 days, or within agreed upon timeframe
Determination MeetingYesDate for meeting agreed upon within 30 days of request
Submission Issue MeetingYes21 days
Day 100 MeetingYes100 days from PMA filing date


According to the guidance, all Q-Subs must be submitted electronically either to the Center for Devices and Radiological Health (CDRH) or Center for Biologics Evaluation and Research (CBER), at which point the FDA will assign unique identification numbers to all Q-Subs.  Agency personnel will conduct acceptance reviews within 14 days for submitted Q-Subs; in instances where FDA reviewers determine that applications do not qualify as Q-Subs, they will issue Refuse to Accept (RTA) notices to applicants explaining their decisions.  Offering multiple regulatory feedback options seems like a good-faith effort on the FDA’s part to minimize unexpected registration setbacks for manufacturers. Hopefully the Q-Sub process itself doesn’t prove too complicated to be of any benefit for US market registrants.

REFERENCE:  Emergo Group; Stewart Eisenhart; 18 FEB 2014

Leave a Comment