When medical device manufacturers need to interact with U.S. regulatory agencies about the products they’re developing, they use the Q-Submission (Q-Sub) program. The program allows manufacturers to engage in collaborative discussions with regulators that can shape the trajectory of a device’s development, clearance or approval, and post-market surveillance.
In June 2023, U.S regulators updated the guidance to the Q-Sub program, and manufacturers need to be aware of the changes if they want to take full advantage of it. After all, the Q-Sub program is one of the most valuable tools in bringing a medical device from conceptualization to commercialization.
Medical device manufacturers who fail to recognize evolving regulatory standards often incur costly delays and failures. An experienced lab testing partner can save time and money by helping manufacturers through the Q-Sub program and offering insight and action plans after receiving regulatory feedback.
How Q-Sub works
The primary goals of the Q-Sub program are threefold: 1) to foster innovative advancements in healthcare technology; 2) ensure the highest level of patient safety; 3) expedite device development and clearance or approval.
The Q-Sub program allows manufacturers and regulators to discuss products, ask clarifying questions, and obtain feedback. This dialogue can range from exploratory conversations about new technologies to specific questions about data needed for a forthcoming regulatory submission.
The increasingly complex and evolving nature of regulation makes the Q-Sub program essential. Manufacturers can gain insight about regulatory thinking, align their strategy with the latest expectations and lay the groundwork for an efficient review process.
The different types of Q-Subs
The Q-Sub program offers a range of submissions, each with a distinct purpose:
- Pre-Submission (pre-sub): This allows device manufacturers to interact with a U.S. regulatory agency at an early stage. Manufacturers can obtain regulatory feedback on device development and evaluation issues before formally submitting. Pre-sub meetings can be used to discuss topics like investigational device exemption (IDE), device classifications and humanitarian device exemption (HDE).
- Study Risk Determination: If a manufacturer is unsure if a regulatory agency would consider a clinical study a significant risk, a nonsignificant risk, or an exempt study, they can use this avenue for clarification. In the U.S., medical devices must be classified into one of three risk categories: class I, II, and III. Risk determination is a critical part of the regulatory process for medical devices. By establishing the level of risk, higher-risk devices can undergo a more rigorous evaluation, ensuring patient safety without hindering lower-risk devices.
- Submission Issue Request: Manufacturers use this type of Q-Sub when they disagree with a regulatory agency decision concerning a 510(k), PMA, HDE or de novo request. Manufacturers can request additional review of decisions or requests.
- Informational Meeting: These are broad, open-ended meetings to help manufacturers better understand regulations and recent changes. Manufacturers can also discuss new technologies or policies on specific topics. The informational meeting is also the default designation if manufacturers want to interact with regulators, but the topic doesn’t fall into any of the above.
Updates to the Q-Sub program
Recent changes to the Q-Sub program aim to optimize the process, improving communication between manufacturers and regulators.
The procedure for requesting Q-Sub meetings has changed, with updated guidelines providing more precise instructions on obtaining a meeting. The new guidance specifies the documents that must be submitted and sets a timeframe for the regulatory agency’s response.
The guidance also underlines the importance of stating a specified purpose for the Q-Sub and the expected outcome of the interaction. This means regulators will understand the manufacturer’s intent more clearly, enabling more focused feedback and reducing the chances of miscommunication.
The update also provides a detailed explanation of the review and feedback process and outlines the roles of different members within the review team. This helps manufacturers to tailor their submissions to the correct audience. Lastly, the update underlines the commitment of regulatory agencies to respond promptly. The guideline specifies target timeframes for each step of the regulatory process.
A final word
Manufacturers who correctly understand and utilize the Q-Sub program stand a considerably better chance of successfully navigating regulatory expectations. The changes, while subtle, should be heeded by any device manufacturer looking to make the most of an opportunity to interact with regulators and streamline what can be a long and laborious process.
Manufacturers can foster healthy relationships with regulators, benefit from early and iterative feedback, and enjoy speedier device development, clearance or approval by making the most of the Q-Sub program.
The easiest way to ensure the most helpful interactions within the Q-Sub program is to work with a knowledgeable and experienced lab testing partner. They can offer a comprehensive understanding of regulatory expectations, assist in preparing for Q-Sub interactions, and put manufacturers on the path to successful regulatory outcomes.
