The US Food and Drug Administration (US FDA) Q-Submission Program serves as a vital channel for medical device manufacturers to engage with the US FDA, enabling them to receive essential feedback that can optimize their submission and development procedures. This program is designed to facilitate organized communication between the FDA and medical device manufacturers. The FDA's Q-Submission Program facilitates direct dialogue between medical device manufacturers and the US FDA, simplifying submissions and offering valuable feedback. Creating a Q-submission demands careful preparation and strict adherence to guidelines.Q-Submission is a formal written entreaty made by an applicant or US Agent to the FDA, seeking feedback through an official written response, a meeting, or a teleconference. The FDA does not impose any charges for Q-Submission meetings. Participation in the Q-Submission program is entirely voluntary for the submitter.
Types of Q-submission Programs
Several Q-Submission Programs serve distinct purposes. It's important to note that specific interactions with the US FDA, such as those concerning Medical Device Development Tools (MDDT), administrative processes tied to submissions, or communications linked to submission reviews, as well as RFD and Pre-RFD interactions related to combination products, do not fall under the category of Q-Submission Programs.
A Pre-Submission (Pre-Sub) allows applicants or US Agents to seek insights through written responses, meetings, or teleconferences before a premarket submission, such as IDE, PMA, HDE, De Novo request, 510(k), Dual, BLA, IND, Accessory Classification Request. A Pre-Sub should include specific questions concerning topics relevant to the planned submission, such as biocompatibility and bench testing. Pre-Subs can be useful for various submission types, including other Q-Submissions, like Accessory Classification Requests, and are especially recommended for Predetermined Change Control Plans (PCCPs) to simplify premarket reviews. Pre-Subs offer an opportunity to collaborate with the US FDA proactively, contributing to streamlined regulatory processes.
Submission Issue Requests (SIRs)
A Submission Issue Request (SIR) is a formal request directed to the US FDA, seeking feedback through written responses or meetings regarding a proposed approach to address issues raised in certain FDA letters, including marketing submission hold letters, IDE Letters, or IND Clinical Hold letters. SIRs serve as a means to promptly resolve questions concerning these issues and facilitate communication between the FDA and submitters. The intent is to address the concerns outlined in these letters effectively, allowing projects to progress. SIR isn't meant for pre-review of formal responses or to discuss final decisions conveyed by FDA letters. Submitters are expected to provide formal responses within the designated timeframe, whether or not a SIR is submitted. Simple clarification requests or issues that don't require management involvement are not suitable for SIRs, nor are discussions during the active review of a file.
Study Risk Determinations
A Study Risk Determination involves requesting the FDA to determine the level of risk associated with a planned medical device clinical study, classifying it as significant risk (SR), non-significant risk (NSR), or exempt from Investigational Device Exemption (IDE) regulations. If the study isn't exempt, sponsors initially decide whether it's SR or NSR and present this determination to the Institutional Review Board (IRB). While sponsors, clinical investigators, and IRBs can collaborate to make this risk assessment, the US FDA is the ultimate authority on SR or NSR classification. The FDA's determination is essential when submitting an IDE to the US FDA or upon request by the sponsor, clinical investigator, or IRB.
An Informational Meeting is a request for sharing information with the FDA, typically without the expectation of receiving feedback. These meetings serve to provide insight into ongoing device development, particularly when multiple submissions are planned in the near future (within the next 6-12 months). They are valuable for introducing the FDA review team to new devices with significantly different technology compared to existing devices. While FDA staff may ask clarifying questions during an informational meeting, the primary purpose is for them to listen, and feedback is usually not provided.
PMA Day 100 Meetings
The meetings held 100 days after the submission of a Premarket Approval (PMA) application are also considered as a type of Q-Submission meeting. The meeting request should be submitted no later than 70 days from the day FDA accepts the PMA for filing. A 30-day lead time is essential for FDA to schedule the meeting. The request should detail the meeting type (e.g., face-to-face, teleconference, or videoconference), list the attendees from the company, and suggest possible meeting dates.
Agreement and Determination Meetings
A Determination Meeting is relevant to prospective PMA or PDP submitters and provides with the US FDA's determination of the required scientific evidence to establish a device's effectiveness for its intended use. The meeting helps decide if clinical studies are necessary and seeks the least burdensome approach to evaluating device effectiveness with a reasonable chance of success. The Agreement Meeting is open to anyone planning to investigate class III products or implants, including 510(k) submitters of eligible devices. It aims to reach an agreement on key investigational plan parameters, including the clinical protocol, typically held within 30 days of the meeting request.
Breakthrough Device Designation Request
The Requests for Breakthrough Device Designation to seek inclusion in the Breakthrough Devices Program based on the criteria or Interactions concerning Designated Breakthrough Devices: To request feedback on device development and clinical protocols for devices that have previously been designated as breakthrough devices.
Safer Technologies Program (STeP)
Submissions associated with the Safer Technologies Program include requests to Enter STeP, to apply for inclusion in the Safer Technologies Program and to request feedback on device development and clinical protocols for devices previously included in STeP.
Accessory Classification Requests
Accessory Classification Requests can be either for an existing accessory type or for a new accessory type. Under this Q-sub program, the submitter can request classification for an accessory that has marketing authorization as part of a premarket submission for another device. The classification request of a new accessory should be submitted in conjunction with the premarket submission for the parent device. These Accessory Classification Requests are treated as Q-Subs and undergo concurrent review and decision-making alongside the parent premarket submission.
Benefits of Q-submission:
The Q-submission program offers several advantages, such as engaging with FDA specialists, obtaining feedback, and promptly establishing areas of agreement. This program is accessible to any sponsor seeking feedback on a prospective or planned medical device submission, including:
Investigational Device Exemption (IDE) Applications
Premarket Approval (PMA) Applications
Humanitarian Device Exemption (HDE) Applications
De Novo requests (Evaluation of Automatic Class III Designations)
Premarket Notification (510(k)) Submissions
Accessory Classification Requests
Essential Elements for Crafting a Q-Sub Application for FDA Meetings:
The core components of a Q-Submission include the following elements. Incorporating these aspects into a Q-Submission equips medical device developers with valuable US FDA insights, significantly improving their product development and submission processes. It's essential to emphasize that all Q-Submission documents must be in English, following the guidelines outlined in the Q-Submission guidance.
Singular Q-sub type per application
Preliminary agenda detailing topics and estimated presentation times
Meeting format preference (in-person or teleconference)
Three or more proposed meeting dates and times
Anticipated attendees with their respective positions, titles, or affiliations
Description of the Product
Steps to apply for the Q-Submission program:
To apply for the Q-Submission program, medical device manufacturers need to follow the guidelines provided by the FDA. Here are the key steps to apply for the Q-Submission program:
Determine the type of Q-Submission needed: The Q-Submission program includes Pre-Submissions, Submission Issue Requests (SIRs), Study Risk Determinations, and Informational Meetings Determine which type of Q-Submission is appropriate for your needs.
Identify the suitable Q-submission type: Choose the type of Q-submission that aligns with your specific requirements.
Thoroughly prepare background details and questions: Ensure accurate preparation of background data and formulate specific questions intended for the FDA.
Submit Q-Submission application: Send a comprehensive application to the FDA, including a cover letter, background details, meeting schedule, specific questions, and response plans.
Manage meeting schedule: Actively coordinate the meeting schedule; meetings can be teleconferences or videoconferences lasting one hour.
Participate in the meeting: Attend and discuss submitted questions.
Receive FDA feedback: Obtain formal feedback through written response, meeting, or teleconference, addressing submitted questions and offering regulatory guidance for your device.
The US FDA's Q-Submission Program stands as a valuable resource for medical device manufacturers, fostering open communication and feedback with the US FDA. By understanding the various types of Q-Submissions and the essential elements of crafting a successful Q-Submission application, manufacturers can significantly improve their product development and submission processes. This program offers a pathway to engage with US FDA specialists, receive prompt feedback, and establish areas of agreement. With the potential to benefit a wide range of medical device submissions, the Q-Submission Program is a boon for manufacturers seeking regulatory guidance. As the medical device industry continues to evolve, staying informed about Q-Submissions and their nuances is essential for success and compliance.
For expert guidance on navigating the Q-Submission process for your medical devices, contact Artixio. Our experienced team can help you optimize your submissions and ensure compliance with FDA regulations.
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