Feb 18, 2014

US medical device market regulators have updated guidance first issued in 2012 on the FDA’s Pre-Submission feedback program for medical device manufacturers undergoing Investigational Device Exemptions (IDE), Premarket Approval (PMA), 510(k) premarket notification or other premarket reviews.

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 Type Meeting as Feedback Method? Timeframe for Meeting from Receipt of Submission
Pre-Submission Upon request 75 – 90 days
Informational Meeting Yes 90 days
Study Risk Determination No N/A
Agreement Meeting Yes 30 days, or within agreed upon timeframe
Determination Meeting Yes Date for meeting agreed upon within 30 days of request
Submission Issue Meeting Yes 21 days
Day 100 Meeting Yes 100 days from PMA filing date

Source: www.FDA.gov

According to the guidance, all Q-Subs must be submitted electronically either to the Center for Devices and Radiological Health or Center for Biologics Evaluation and Research, 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.

Stewart Eisenhart


  • Stewart Eisenhart