So many questions come up when developing a medical device. What is its intended purpose? Who will use it? How will it be used? What do we need to do? Questions surrounding the medical device regulations and the paperwork involved can be intimidating. Setting up a Q-Submission meeting with the FDA can help if you have specific questions, especially if it’s your first time developing a device or submitting to the FDA. What does Q-Submission stand for? What does Q-Sub mean with the FDA? What is the Q-Submission program for medical devices? We’ll answer these questions, and address when in your development process you can use the Q-Submission program so that bringing your medical device to market becomes less stressful. With our Q-Sub guidance, medical device manufacturers like you can utilize the program to speed up the product development process and get their devices to the US market sooner.
What Is a Q-Sub?
Understanding the regulatory framework for new medical devices can be a complex, overwhelming process. Enter the FDA Pre-Submission, a regulatory tool that allows medical device developers to submit a formal written request with questions and concerns. The Pre-Submission program enables medical device and in vitro diagnostic (IVD) manufacturers to request feedback from FDA experts on various aspects of the regulatory process. What is the difference between FDA Pre-Sub and Q-Sub? The submission to the FDA is given a ‘Q’ identification number, and is often referred to as a Q-Sub. Thus, when referring to a Q-Sub vs. a Pre-Sub, they are the same thing. Such a request can often make the overall submission process easier, whether your marketing submission is a 510(k), de novo request, or PMA.
Why Do You Need (Or Want) a Q-Sub?
If done correctly, the Pre-Submission program can benefit both the FDA and device developers. The FDA strongly endorses and promotes Q-Subs because their experts value the advanced insight and understanding of new developments in the healthcare industry. Conversation and discussion between device manufacturers and the FDA also provide developers with valuable information that can streamline their submission and overall development process. The Q-Sub program is also when the FDA assigns a project manager (PM). The PM relationship is often invaluable to device sponsors.
Another advantage of the program is that the FDA does not require companies to pay any fees for Q-Subs and does not impose any restrictions on the number of meetings developers can request. However, at times, this open access can become a drawback. The Pre-Submission process, which takes about six weeks to obtain a response or a meeting, can end up delaying device development companies. Device sponsors often ask a lot of questions in their first submission but get limited usable information. So, they try again, waiting even longer. In the long run, this cycle will hinder product development and delay market entry.
Who Needs a Q-Sub?
Although Pre-Sub meetings are not mandatory, we often recommend them to give developers the opportunity to engage with the FDA early in the development process of new medical devices if you have specific questions for the agency. You can seek guidance and gain valuable feedback on various topics, such as costly bench and animal testing, clinical trials, and overall regulatory strategy, by submitting a formal request for a Q-Submission meeting. Depending on the nature of the questions, Q-Submission meetings may also be referred to as Pre-Submissions, Submission Issue Requests, Study Risk Determinations, and Informational Meetings. Here are some example situations where medical device developers may want to consider submitting a Q-Submission to the FDA:
- Before conducting studies that are not defined in a guidance document. If your device requires studies that are not already outlined in existing guidance documents, it’s a good idea to request a Q-Submission. This will allow you to receive feedback from the FDA on your proposed testing methods and ensure they are appropriate for your device.
- Determination of whether a device study is either significant risk (SR), non-significant risk (NSR), or exempt from IDE.
- For devices with novel technology or design. Devices with novel technology or design may not fit neatly into existing regulatory categories. In these cases, a Q-Submission can be helpful in determining the appropriate regulatory pathway and ensuring that your device meets regulatory requirements.
- For devices with significantly different indications for use. If your device’s indications for use are significantly different from an existing 510(k)-cleared device, a Q-Submission can be helpful in getting feedback from the FDA on the most appropriate regulatory pathway.
- For studies being conducted outside of the United States. If you’re conducting studies outside of the United States, the Q-Submission program can help ensure that your study design and methods meet FDA requirements and streamline the regulatory review process.
Examples of Pre-Submissions improving the medical device development process include a digital health company that sought FDA feedback on its clinical development plan through a Pre-Submission request, resulting in a successful premarket approval for their device. Another example is a company that submitted a Q-Submission to the FDA to get feedback on their device’s user interface, which helped them improve the device’s design and overall user experience.
When Should You Request a Q-Sub?
The timeline for a Q-submission meeting with the FDA can be a lengthy process and needs to be planned out carefully to ensure that the meeting is successful. A Q-Submission is beneficial at any stage of development, but it is particularly useful before initiating the most expensive and laborious aspects of product development, such as bench, animal, and clinical testing. When it comes to testing Class II medical devices, choosing a predicate device is often linked to the testing plan as the plan is usually based on the testing done on the selected predicate. To better understand what kind of data you need to collect for approval/clearance, you can contact the agency before starting the testing and selecting a predicate. Submitting a Pre-Submission for a product that has already undergone testing can still be beneficial as it allows for presenting complex data or conclusions to the FDA before a full submission review.
The meeting timeline (after the preparation of your Pre-Submission materials) will follow FDA guidelines outlined below. As you can see, with so many steps, the time between requesting a meeting and receiving final written minutes can easily exceed 60 days.
- Understanding regulatory submission requirements and gathering the necessary data and documentation.
- Reviewing the application documents and compiling questions for the FDA.
- Submission of Pre-Submission meeting application. Within 15 days of the clock starting, the FDA will conduct an acceptance review using the Acceptance Checklist. If the agency rejects the application, they will let you know, along with an explanation. You can then reply with a Q-Submission Amendment.
- Schedule meeting. If a Pre-Sub meeting is accepted, a notification will confirm the submitter’s requested meeting date or provide two alternative dates that are scheduled prior to day 75 of receipt of submission.
- Meeting minutes. You are responsible for creating and submitting meeting minutes for review within 15 days of the meeting. If no revisions are necessary, the meeting minutes will be considered final. However, if the FDA decides to make changes to the draft minutes, an updated version will be sent within 30 days. In this scenario, the minutes will only be considered final 15 days following receipt of the edited version.
How To Prepare a Successful Q-Sub
Preparing for any kind of government submission process is a daunting task, and it’s no different when it comes to Q-Submissions. It’s critical that medical device manufacturers take the time to fully prepare and have a solid understanding of the Pre-Submission program. Here’s some tips to make things go smoother:
- Identify key issues.
To ensure an effective meeting, keep the number of questions per session between three and five. What are the areas of greatest concern where you need FDA feedback? Asking “please confirm” or “do you agree” lets you propose a solution and allows the agency to agree. This method of questioning is generally very effective. Do not ask open-ended questions. - Be clear, concise, and logical.
A Pre-Submission should be treated with the same level of attention and care as any other application to the FDA. To increase the chances of getting FDA approval, it is often helpful to seek a review of the submission by someone outside the team who can provide feedback on its clarity. The purpose of this review is to improve understanding for a potential FDA reviewer. It is important to keep in mind that both the written submission and the meeting can impact the impression you make on the FDA, whether it be positive or negative.
Here are some things to avoid in an FDA submission meeting:
- Not preparing well
Not preparing adequately for the meeting is a surefire way to waste time and resources. One should have a clear understanding of the process, the objective of the meeting, and the questions that need to be answered. A Pre-Submission meeting is not a time for a company to present ideas but is an opportunity to seek feedback from the FDA. - Arguing with the FDA
The FDA is there to help; arguing with them can be counterproductive. Sponsors that challenge the FDA’s position can create unnecessary tension and delay. Instead, companies should acknowledge feedback and express a willingness to work collaboratively on solutions. - Neglecting meeting minutes
Drafting meeting minutes is crucial for reference and serves as a reliable basis for the next meeting. Failing to produce them slows the process down and creates ambiguity. In conclusion, a successful FDA Q-Submission can be key to the success of a medical device submission by gaining valuable feedback ahead of the application. Effective preparation that includes clear and concise communication, and understanding the submission timeline and process will lead to a successful Pre-Sub meeting with the FDA. Medical device companies should know when and how to navigate the FDA Pre-Submission process to reduce uncertainty and better ensure success both in preparing for and conducting a Q-Submission meeting with the FDA. Let our team guide you through this complex process by providing experienced assistance throughout all stages of your medical device submissions. Please contact us today.
