1. What is the FDA Q-submission program?
Q-submission FDA program refers to the system that tracks the collection of interactions with the FDA. It helps manufacturers of Medical Devices and in vitro diagnostics (IVDs) to obtain feedback from the FDA regarding Regulatory processes and requirements for the product during its development.
2. What is the difference between a Pre-submission and a Q-submission?
Pre-submissions or Pre-subs are a subset of Q- subs. They are only interchangeable when referring to Pre-subs. Other types of Q-subs, as per the updated final guidance released in 2019, are:
- Submission Issue Requests (SIRs)
- Study Risk Determination
- Informational Meetings
Other Q-sub types are technically submitted under the Q-sub process but have their guidance documents -PMA Day 100 Conference, Agreement and Decision under the United States Food and Drug Administration Modernization Act (FDAMA) Meetings, breakthrough device program submissions, Safer Technologies Progam (SteP) and accessory classification requests.
3. Is it mandatory to have a Pre-sub meeting with FDA before a Premarket notification?
The program is completely voluntary on the part of the submitter. However, early interaction with the FDA on device design, technology characteristics, predicate device, and its substantial equivalence for careful consideration of FDA’s feedback may improve the quality of subsequent submissions, transparency, shorten total review times, and facilitate the development process for your device.
4. What is the FDA Q-submission fee?
The FDA does not charge any fee for any Q-submission meeting.
5. What are the contents of a Q-sub application for requesting a meeting?
First and foremost, all the Q-sub documents must be in the English language. The content for Q-submission as per the Q-submission guidance includes:
- Cover letter
- Contact information
- Q-sub type (only one Q-sub type to be included in each submission)
- A draft agenda proposing topics to be presented and estimated time for each agenda item
- Meeting format (in-person or teleconference)
- Three or more dates or times when you’re available to meet
- Planned attendees, including their position, title, or affiliation
- Product description
- Proposed indications for use
- Regulatory History
6. How many Pre-Subs can I submit for a single submission?
There is no limitation on the number of pre-submissions for a single device submission. However, you cannot do more than one pre-submission at the same time. You need to wait for FDA’s feedback for the previous pre-submission before doing the next pre-submission
7. What is the next step if the FDA rejects my Pre-submission request?
If the acceptance review by the FDA determines that the request does not qualify as a Pre-submission, the submitter will receive a notification of this decision with the reasons for refusal.
The submitter may respond to a Refuse to Accept (RTA) notification by submitting additional information to the Document Control Centre (DCC), which will be logged in as an amendment to the Q-Sub. Within 15 days of receiving the newly submitted information, FDA staff will conduct the acceptance review again. The subsequent acceptance review will assess whether the new information makes the submission complete according to the Acceptance Checklist.
8. Does Pre-sub guarantee approval or clearance of submissions?
Review of information in a Pre-Sub does not guarantee approval or clearance of future submissions. Additional questions may be raised during the review of the future submission when all information is considered as a whole, or if new information has become available since the Pre-Sub.
9. Does the FDA modify its feedback on Pre-sub under any circumstances?
Modifications to FDA’s feedback will be limited to situations in which the FDA concludes that the feedback given previously is not addressing important new issues that have emerged since the time of the FDA Pre-Submission, and that is materially relevant to a determination of a reasonable assurance of safety and/or effectiveness, substantial equivalence, or other relevant Regulatory decision.
10. Is submission of meeting request for a Pre-sub same for single entity devices and combination products?
Requests for meetings regarding a combination product should be submitted to the lead center for the product, following that center’s corresponding processes. Accordingly, Q-submissions should only be submitted for device-led combination products assigned to Center for Drug Evaluation and Research (CDRH) or to the Center for Biologics Evaluation and Research (CBER). If the classification or center assignment for a medical product is unclear, the submitter should submit an RFD or Pre-RFD to the Office of Combination Product (OCP), and then submit their meeting request to the center determined to be the lead center.
In case of any more queries and assistance for Q-submissions or device registration in the U.S., you can reach out to a Regulatory expert like Freyr.
Stay informed, and stay compliant!