Wherever you are in your product development lifecycle,
Sterling can help.
Author: Tara Miller | Date: May 16, 2023
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.
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.
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.
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:
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.
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.
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:
Here are some things to avoid in an FDA submission meeting:
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