The Q-Submission Program, also known as the Pre-Submission Program, is an initiative by the U.S. Food and Drug Administration (FDA) aimed at facilitating the development and review of medical devices. It provides an opportunity for medical device manufacturers to interact with the FDA before submitting their formal applications, allowing for early feedback and guidance.
The FDA updated its final guidance on its Q-Submission program in June 2023i, ahead of the release of a new draft guidance on Pre-Submissions. The updated guidance includes a number of changes, including:
- A new section on Predetermined Change Control Plans (PCCPs), which allows sponsors to get Pre-Sub feedback on their plans for making changes to a device after it has been cleared or approved.
- Examples of common review topics and questions for a Pre-Sub request.
- Timing considerations for multiple submissions.
- Administrative content to include in Q-Subs to facilitate FDA review.
- Q-Sub meeting minutes format and submission process.
- Existing mechanisms to obtain FDA feedback outside of the Q-Sub Program.
The updated guidance also clarifies that Q-Subs can be used to request feedback on a wide range of topics, including:
- The classification of a device.
- The design and performance of a device.
- The clinical evidence supporting a device.
- The manufacturing and quality control procedures for a device.
- The labeling for a device.
The FDA also plans to release a draft guidance on Pre-Submissions soon. This guidance will provide more detailed information on how sponsors can request feedback from the FDA on their medical device development plans.
Overall, the updated Q-Sub guidance and the upcoming Pre-Submission guidance are designed to help sponsors get the feedback they need from the FDA early in the device development process. This can help to streamline the review and approval process for medical devices, and ultimately make new and innovative devices available to patients more quickly.
Here are some of the key takeaways from the updated Q-Sub guidance:
- Q-Subs can be used to request feedback on a wide range of topics related to medical device development.
- The FDA encourages sponsors to use Q-Subs early in the development process to get feedback on their plans and to avoid costly mistakes later.
- Q-Subs are a voluntary program, and there is no guarantee that the FDA will provide feedback on every request.
If you are a sponsor of a medical device, we encourage you to review the updated Q-Sub guidance and to consider using Q-Subs to get early feedback from the FDA on your development plans. This can help you to streamline the review and approval process and to make your device available to patients more quickly.
Does your company need help with Q-sub? AlvaMed has experience helping companies navigate their Q-subs. Reach out to AlvaMed at [email protected] to find out how we can assist you.
[1] https://www.fda.gov/media/114034/download
