Before committing to a medical device submission, many companies want to know where FDA stands. Is the testing plan adequate? Will the clinical study design hold up? Is this even the right regulatory pathway? These questions are far easier to settle early than halfway through a review.
That’s what the Q-Submission (Q-Sub) Program is for. Taking part is voluntary. FDA may answer in writing, hold a meeting with you or use some other format, depending on the request.
This guide covers the main Q-Sub types, what to put in a request and what happens after you submit it.
Q-Submission Meetings
The Q-Sub Program brings together several kinds of interactions related to medical device submissions. Some result in written feedback, some involve a meeting with FDA reviewers, and others take a different form altogether.
The Pre-Submission (Pre-Sub) is the best-known example. Here, a company puts specific questions about its planned submission to FDA, and FDA replies in writing. If the company requests it, a meeting can follow, either in person or virtually.
Not every Q-Submission leads to a meeting, though, and the types don’t all serve the same purpose. The right choice depends on what kind of input you actually need from FDA.
Types of FDA Q-Submissions
Each Q-Sub type has its own role. Some help you get FDA’s input before filing a medical device application. Others deal with questions raised during an ongoing review, or simply give you a chance to brief FDA on your plans.
Here are the main types.
Pre-Submission (Pre-Sub)
A Pre-Sub is how you get FDA’s feedback ahead of certain applications, including 510(k), De Novo, Premarket Approval (PMA) and Investigational Device Exemption (IDE) applications.
Your request should pose specific questions about the planned submission. Typical topics include biocompatibility, bench testing, cybersecurity and clinical study design.
FDA responds with formal written feedback, and you can ask for a meeting to talk it through.
Pre-Subs are especially valuable when you want FDA’s view before running planned tests. FDA also recommends using a Pre-Sub to discuss a Predetermined Change Control Plan (PCCP) before you include one in a premarket submission.
Also Read: 510(k) Registration with US FDA
Submission Issue Requests (SIRs)
An SIR lets you discuss how you intend to resolve certain issues FDA has raised in a letter.
Say you’ve received an Additional Information request during a 510(k) review, or a Major Deficiency letter during a PMA review. An SIR gives you a way to run your proposed approach past FDA, either through written feedback or a meeting.
Two limits are worth keeping in mind. FDA won’t use an SIR to pre-review a completed response, and submitting one doesn’t extend your deadline for the formal response.
Study Risk Determinations
Sponsors, clinical investigators and Institutional Review Boards (IRBs) can use this route to ask FDA how risky a planned medical device clinical investigation is.
FDA may decide that the study involves:
- Significant risk (SR)
- Nonsignificant risk (NSR)
- A study exempt from most Investigational Device Exemption (IDE) requirements
For non-exempt investigations, the sponsor makes the first call on whether the study is significant or nonsignificant risk and presents that assessment to the IRB.
The final determination rests with FDA. It makes that decision when an IDE is submitted, or when the sponsor, clinical investigator or IRB asks it to.
Informational Meetings
An Informational Meeting lets you share your device development plans without expecting formal feedback.
It may be worth requesting one when the device’s technology differs substantially from existing products. The same goes for companies expecting to make several submissions over the next 6–12 months.
It gives FDA reviewers an early look at the device and where its development is heading. They may ask questions to clarify things. Don’t expect formal feedback, though; that isn’t what this meeting is for.
PMA Day 100 Meetings
This meeting gives applicants a chance to discuss where their original Premarket Approval (PMA) application stands in review.
You can request it in the original PMA cover letter or through a separate Q-Submission.
Going with a separate Q-Sub? Then FDA recommends getting the request in no later than 70 calendar days after receipt of a PMA accepted for filing (or after the amendment that enables the PMA to be filed).
Unless FDA and the applicant settle on a different schedule, the meeting generally takes place within 100 calendar days of the PMA filing date.
On the agenda: any deficiencies FDA has identified, how they might be corrected and the steps left in the review.
Other Submission Types Tracked Under the Q-Submission Program
Beyond the five interaction types above, FDA also uses the Q-Sub Program to track certain requests linked to other medical device programs. Separate guidance and procedures apply to each one.
Agreement and Determination Meetings
Eligible device developers can use these meetings to discuss clinical study requirements with FDA, or to reach agreement on certain investigational plans.
Breakthrough Devices Program
FDA tracks Breakthrough Device Designation Requests through the Q-Sub Program, along with certain interactions for devices that already hold breakthrough designation.
Safer Technologies Program (STeP)
Requests for entry into STeP fall under the program, as do certain interactions on device development and clinical protocols for devices already accepted into it.
Accessory Classification Requests
Manufacturers use these to seek the right classification for a medical device accessory.
A request may involve an existing accessory type or a new one. FDA has a specific procedure for each. For a new accessory type, FDA recommends submitting the request together with the parent device’s premarket submission.
Each of these programs handles requirements and review a little differently. Go by the guidance written for the one you’re using.
Why Use the Q-Submission Program?
Through the program, you can take a specific regulatory or scientific question straight to FDA reviewers. What you get back varies with the type of interaction.
Take a Pre-Sub. You might ask about planned testing, a clinical study or the submission itself. The answers may bring concerns to light before your studies are finished or your main submission is drafted. There’s room to discuss your proposed approach too, and to factor in what FDA recommends. Getting that input early may make the later submission easier to prepare, with fewer avoidable changes.
Other Q-Sub types work differently. An SIR deals with issues raised in certain FDA letters. An Informational Meeting is for sharing development plans, with no formal feedback expected.
None of this guarantees FDA clearance or approval. It is still up to the company to decide how to act on FDA’s feedback and to meet the requirements for any later submission.
Requirements for an FDA Q-Submission
Whatever the type, your Q-Submission should make its purpose obvious to FDA.
Start with a cover letter that includes the submitter’s contact details. Is someone else handling communication with FDA? Add their details too.
Clearly state which Q-Sub type you’re submitting. FDA generally recommends one Q-Sub type per request. Some types offer a choice of feedback options; if yours does, mention the one you want.
A meeting request also needs:
- a draft agenda;
- your preferred meeting format;
- three or more dates and times that would work for you; and
- who will attend (names or roles).
Beyond that, the content changes with the Q-Sub type.
Pre-Subs need context. Reviewers have to grasp what the device is and what you’re asking from the material in front of them. So, depending on the request, you might send the device description and intended use, plus any previous regulatory history, testing information and related supporting material.
Be precise with the questions. FDA’s advice is to keep a Pre-Sub focused and not pile too many major topics into a single request.
What else goes in varies from one type to another. A Study Risk Determination request has to come with the proposed clinical study protocol. An SIR, on the other hand, should keep to the issue FDA already raised and the points that are still unclear to you.
Two things apply across the board: the submission goes in English, and it has to meet the requirements for the Q-Sub type you picked.
How to Apply for an FDA Q-Submission: Step by Step
Each Q-Sub type has its own particulars. In broad terms, though, the process runs as follows.
1. Pick the Q-Sub type that fits
First, work out what you actually want from FDA. Feedback ahead of a future submission may point to a Pre-Sub. Resolving review issues, getting a study risk determination or arranging an informational meeting each call for a different type.
2. Put the request together
FDA will need to understand both the device and your questions. Depending on the type, the package may include the device description, intended use, regulatory background, testing information and supporting documents.
3. Select the submission format
FDA accepts different electronic submission routes depending on the Q-Sub type.
For Pre-Submissions, an eCopy is required unless you use the voluntary PreSTAR option.
For several other types, including Submission Issue Requests, Study Risk Determinations, Informational Meetings and PMA Day 100 Meetings, eCopy is voluntary. FDA also offers PreSTAR on a voluntary basis for several Q-Sub types.
4. Submit the Q-Submission
Use the FDA route that applies to your format and Q-Sub type. Supported electronic CDRH submissions go through the CDRH Portal, which also lets submitters track certain submission types once FDA has received them.
5. Go through FDA’s feedback (and prepare for the meeting, if there is one)
For some Q-Sub types, written feedback arrives before the meeting. Go through it closely. The meeting time is better spent on questions the written response left open.
After a Pre-Sub meeting, the submitter must draft the meeting minutes and send them to FDA as an amendment within 15 days.
6. Carry the feedback into your next step
FDA feedback does not require a company to follow a particular approach, but a later related submission should explain how the earlier feedback was addressed or why a different approach was taken.
Also Read: Medical Device Registration Process in USA by US FDA
FDA Q-Submission Timelines
FDA’s target timeline depends on the type of Q-Submission.
- Pre-Submission: written feedback is generally provided within 70 calendar days. If a meeting is requested, FDA provides written feedback at least 5 days before the meeting and no later than day 70. Meetings are typically scheduled around days 70–75.
- Submission Issue Request: FDA aims to provide feedback or hold the meeting within 21 days when the SIR is submitted within 60 days of the applicable FDA letter, as resources permit. If submitted later, the target is 70 days.
- Study Risk Determination: FDA generally provides its determination within 90 days.
- Informational Meeting: the target is generally 90 days.
- PMA Day 100 Meeting: held within 100 days of the PMA filing date.
These are FDA target timeframes and can vary depending on the request and circumstances.
Does FDA Charge Fees for Q-Submissions?
Not for a Pre-Submission. FDA currently charges no user fee for it, as it sits within the voluntary Q-Submission Program.
That said, later submissions aren’t necessarily free. You’ll pay a user fee for most 510(k)s, PMAs and De Novo requests, and for some other premarket submissions as well. Any fee is tied to that later submission, not to the Pre-Sub.
There can be other costs, of course. Your own team’s time goes into preparing a Q-Submission, and so does the fee for any consultant you hire. Neither of these is an FDA user fee.
When Can FDA Q-Submission Consulting Support Help?
Using a consultant is not an FDA requirement. Some companies bring one in anyway, for example when preparing their first Q-Sub or working on a novel device. Typical help includes choosing the Q-Sub type and wording the questions so FDA can answer them clearly. Consultants can also organise supporting information, prepare the team for the meeting and help interpret FDA’s feedback when planning the next step.
Conclusion
Used well, a Q-Submission lets a device company put specific questions to FDA, sort out review issues and get feedback before taking the next regulatory step. Since the right Q-Sub type depends on the purpose of the interaction, it pays to prepare focused questions, provide the relevant background and follow FDA’s current submission requirements.
For support with U.S. medical device regulatory strategy, FDA interactions and submission planning, explore Artixio’s United States Regulatory Services.
