Ready to bring your medical device to market? Find out how to navigate the pre-submission process with this essential guide.
The FDA Pre-Submission Program (formerly known as the Pre-IDE Program) allows medical device and in vitro diagnostic (IVD) manufacturers to discuss specific aspects of the regulatory process and requirements with FDA experts. A Pre-Sub is commonly referred to as a Q-Sub, as the submission to the FDA is assigned a 'Q' identification number. The Q-Submission program is a mechanism available to request feedback from the FDA to help guide product development and/or application preparation. The FDA Pre-Sub program can prove especially valuable for devices utilizing Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices, novel technologies, or those with indications that qualify them as "first of a kind" devices. To start the FDA Q-Submission process, you must formally request a Pre-Sub meeting with the FDA. The contents of your Q-Sub submission for requesting a meeting should include a cover letter, a thorough description of your medical device along with its proposed intended use, the mechanism of action on the body, its technological features, and any other relevant information.
The Pre-Sub program is not a requirement and may not need to be employed in the case of simple, straightforward 510(k) submissions that a sponsor/applicant has previously executed. However, it can save sponsors valuable time and money in the long run.
In the draft guidance from the FDA on “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions” as discussed in our blog “What does FDA’s Draft Predetermined Change Control Plan PCCP for AIML-DSF recommend?”, the FDA encourages the companies to discuss their plans through a Pre-Submission. (PCCPs are not authorized in PreSubmissions.)
Scheduling a Pre-Sub meeting with the FDA
According to the FDA, meeting dates between 60-75 days following FDA receipt of your submission are most likely to be feasible. If the FDA cannot accommodate one of the submitter's requested dates, they will offer at least two alternative dates that are prior to 75 days from the receipt date of an accepted submission. The duration of scheduling a Pre-Sub meeting with the FDA may vary depending on the availability of both parties. However, the FDA strives to hold a meeting within 75 days of receipt of an accepted submission.
Process for requesting a Pre-Sub meeting with the FDA
To request a Pre-Sub meeting with the FDA, you must submit a formal written request that includes a cover letter, a thorough description of your medical device along with its proposed intended use, the mechanism of action on the body, its technological characteristics, your planned testing strategy, and specific questions on which you are requesting input from the FDA. You must submit your Pre-Sub meeting request before submitting your 510(k) or premarket application (PMA) review process, or before beginning a clinical study. The type of meeting can be either a face-to-face meeting or a teleconference with appropriate FDA personnel, or you may simply request feedback via an email response.
Missteps to Avoid
When submitting a Pre-Sub request to the FDA, there are some common mistakes to avoid. One mistake is not providing enough information about the medical device, its intended use, and its technological features. Another mistake is not asking specific questions on which you are requesting input from the FDA. It is important to avoid asking questions that are too general, such as "Is this data sufficient?" because you will get a party-line response. Instead, ask about endpoints, statistical analysis, test method, etc. It is also important to avoid submitting a Pre-Sub request too late in the development process. The FDA Pre-Sub program is designed to support successful registration of medical devices. Therefore, it is important to consider the Pre-Sub program as a strategy for continually improving quality at the early stages of product development.
Questions to consider for Pre-Sub meeting
During a Pre-Sub meeting, device manufacturers can obtain targeted feedback by asking specific questions of the FDA.
Some examples of questions that can be asked during a Pre-Sub meeting include:
- Is this the right regulatory application type?
- Sample sizes for clinical trials appropriate?
- Non-clinical testing protocols appropriate?
- Statistical considerations used for the protocols?
- Important endpoints for the clinical study acceptable?
- Feedback on safety concerns for the device?
- Performance characteristics used of the device?
It is important to ask specific questions that are relevant to the device and its intended use, and to provide enough information about the device to allow the FDA to provide meaningful feedback.
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