USA Regulatory ServicesAt MedReg, we help medical device manufacturers prepare FDA Q-Submission requests to obtain feedback on regulatory, scientific, clinical, and nonclinical questions before a planned FDA submission.
What is Q-Submission
Pre-Submission provides the opportunity for a submitter to obtain FDA feedback prior to an intended premarket submission. The request should include specific questions regarding review topics relevant to a planned marketing submission.
Types of Q-Submission with timeframe
- Pre-Submission
- Meeting with written feedback provided in advance
- Written Feedback: 70 days or 5 days prior to scheduled meeting, whichever is sooner
- Meeting: Date based on mutual agreement (typically day 60-75)
- Written Feedback Only: 70 days
- Submission Issue Request (SIR)
Meeting or Written Feedback:
- If SIR is received within 60 days of an applicable FDA letter: 21 days as resources permit
- If SIR is received more than 60 days after an applicable FDA letter: 70 days as resources permit
- Study Risk Determination
Formal Letter: 90 days
- Informational Meeting
Meeting: 90 days
- PMA Day 100 Meeting
Meeting: 100 days from the PMA filing date
Q-Submission Processes
- Submission Content
Q-Submission should be written in English language. It includes cover letter, device description, Proposed indication for use, meeting information, method of feedback, regulatory history, etc.
- FDA Submission Tracking
Q-submission submitted to CDRH whether it is original, Supplement or Amendment. CDRH will assign a number for tracking the submission.
- Meeting Information
Meetings allow for an open discussion and exchange of technical, scientific, and regulatory information that can help to build a common understanding of FDA’s views on clinical, nonclinical, or analytical studies related to an IDE, Accessory Classification Request, or marketing submission.
