Q-Submission Meeting

Overview

US FDA has various mechanisms to facilitate interaction with the Agency regarding various applications that can be submitted for medical devices of varied risk classes. The early engagement with the Agency is facilitated through request for feedback or a meeting with the US FDA under the “Q-Submission Program”. This program enables interaction with the FDA on study and data considerations to improve quality of submissions, reduced review timelines and avoidance of unnecessary pre-clinical or clinical studies.

The applicants with an intention to apply for below listed applications may opt for a Q-Submission Meeting before making actual submissions -

• Investigational Device Exemption (IDE) Applications
• Premarket Approval (PMA) Applications
• Humanitarian Device Exemption (HDE) Applications
• Evaluation of Automatic Class III Designations (De Novo requests)
• Premarket Notification (510(k)) Submissions
• Clinical Laboratory Improvement Amendments (CLIA) Waiver by Applications (CW)
• Dual 510(k) and CLIA Waiver by Application Submissions (Duals)
• Accessory Classification Requests

The Q-submission meeting can be taken up in-person or through tele-conference. Based on the intended outcome from the interaction, there are different types of Q-Submission meetings for the applicant to choose from, such as:

• Pre-Submission Meetings (Pre-Subs)
• Submission Issue Requests (SIRs)
• Study Risk Determinations
• Informational Meetings

The device manufacturers find the whole process of Q-submission pathway overwhelming and challenging, owing to below listed reasons –

• Determining the objective and expected outcome from the meeting
• Presenting appropriate device information
• Framing correct set of questions
• Evaluation of available types of meeting and making the right choice
• Choosing appropriate method of feedback