The Lure of the FDA Q-Sub Meeting:
When (and When Not) to Call for One

Part 1: Timing considerations

Jim Kasic, CEO & Chairman, Boulder iQ

Ah. The Q-Sub. The FDA loves Q-Sub meetings, manufacturers love to get FDA input and they’re free. What’s the issue?

There is no issue – when product developers use the program well. That entails knowing when to call for a Q-Sub meeting, and knowing how to utilize the program to speed the development process and time to market.

Also known as the Pre-Submission Program, or Q-Sub for short, the FDA’s Pre-Submission Program gives manufacturers of medical device and in vitro diagnostic devices a way to get feedback on the regulatory process and requirements for their devices. The Q-Sub program began with the Pre-IDE feedback system of the mid-1990s. The FDA then launched the Pre-Submission Program and expanded PreIDE‑ communications in 2013. In 2019, the FDA broadened the scope of the Q-Sub process further.

Timing considerations for a Q-sub meeting

One of the most commonly asked questions and most frequently discussed topics in the development process is about when to do a Q-Sub meeting. Do it too early, and a manufacturer will not have enough information to get truly helpful answers from the FDA. Do it too late, and the manufacturer could face serious setbacks in getting a product to market, because they’ve learned they’ll need to make key adjustments in the development process.

Consider calling for a Q-Sub meeting when: 

You know you will need specific information on your product classification before you complete your regulatory submission for any Class I, II or III device.

FDA input can be especially useful for devices that incorporate new technologies, or that are “first of a kind” devices. You may gain valuable information to tweak your development process and to streamline the regulatory submission process. In fact, the FDA actively encourages device manufacturers to use the Q-Sub process because doing so helps the final submission’s overall quality. However, Q-Sub meeting information is not binding, and should never be confused with a 513(g), which is a binding decision on a product classification code.

You have well-thought-out, specific questions.

Because the FDA welcomes Q-Subs, they like to know what is going on in device development, and because Q-Sub meetings are free, developers sometimes want to jump in with a barrage of questions. Particularly if the questions are ones the manufacturer could answer itself, this becomes a grand waste of time. It also sends the message to the FDA that the device developer has not been thorough in its preparation and organization.
Remember that the FDA maintains all materials presented for and at the meeting in a company file. They will refer to that file in any other communications or submissions, so it’s important to be clear, consistent and professional in any Q-Sub meeting.

You are ready, willing and able to dedicate time and effort to proper preparation.

Preparing for a Q-Sub meeting is time-consuming and challenging. Here at Boulder iQ, we will typically take 20-60 hours over two to three months to assemble, organize and present the right background information and questions for an effective, valuable Q-Sub meeting.

First, the FDA needs the right kind and amount of background on a company and a product to provide good, comprehensive responses to questions. As passionate as a developer may be about its product, it is important to avoid weighing down the FDA with information. Providing too much can be confusing. The result is inability to answer questions and referrals to a myriad of documents that may or may not be helpful.

Then, the company needs to develop good, on-topic questions. While every situation is unique, it is usually best to ask no more than four very well-thought-out questions. Asking questions that are too general simply wastes time. Types of questions that fall under this category might be along the lines of:

    • What kind of testing do we need to do?
    • What’s the reimbursement code?
    • Is my device a 510(k) device?
    • What materials should we use?

On the other hand, if the company asked the following types of questions, chances are extremely high that responses would be on target, helpful – and let the company quickly adjust as necessary to meet its roadmap.

    • We think that the technology we are using means that our device will fall into a (specified) code for the following reasons. Does the FDA agree? If not, please comment.
    • We think that we will need to perform (x, y, z) testing for the following reasons. Does the FDA agree? If not, please comment.

The Phase 0 question

In terms of exact timeframes, some developers are anxious to take advantage of the Q-Sub program and request a meeting early on during Phase 0, before the design control process starts. Whether or not that’s a smart idea depends on the company and situation. Usually, one of two scenarios prevails.

One is where the developer has had a professional regulatory expert plan a strong regulatory route to market. In that case, the company may not need a Q-Sub at all – during Phase 0 or later. The other scenario is one in which the manufacturer has enough unknowns and questions to really need FDA input on its product classification code and/or what standards or guidance documents to follow. In that case, a Phase 0 Q-Sub may make sense.

For example, take a company developing a device that is similar to existing devices in function but is using different internal technology. They may have specific, legitimate questions on whether the device falls under the standard device category or a different one for the technology it’s using. Here, a Phase 0 Q-Sub could be very helpful. The information the company could learn in the meeting could significantly impact its design control process and everything else down the line.

If you are thinking about requesting a Phase 0 Q-Sub, also consider that all material you submit and present during the meeting will go into a reference file the FDA maintains on your company. If you have a Phase 0 Q-Sub and then pivot significantly in design – which happens frequently in device development – it may confuse the FDA when it comes time for regulatory submission or even a second Q-Sub meeting.

Because many design changes can take place early on, it may be advantageous to wait until you complete Phase 1, design input, to request a Q-Sub meeting. Then you should be able to provide the FDA with the product requirements document, regulatory strategy and instructions for use. With that information, the FDA should be able to confidently and comprehensively respond to questions.

In our next newsletter, Part 2 of “The Lure of the FDA Q-Sub Meeting: When (and When Not) to Call for One” will cover strategic considerations for multiple Q-Sub meetings, how to structure and plan out the meeting, and choice of meeting spokesperson.