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FDA Medical Device, Overview of Q-Submissions

July 12 2022

Q-Submission offers important opportunities for you to share information with FDA and receive input outside of the submission of an IDE, IND, marketing submission, or CW.

Q-Sub can serve as helpful tools in the premarket submission process. For example, in a given product’s development cycle, a submitter may wish to conduct an Informational Meeting, followed by a request for Breakthrough Device Designation, with later discussions to refine specific aspects of non-clinical and clinical testing through Pre-subs.

Q-Submission Types

There are many different types of Q-Submissions that cater to each factor, depending on the circumstances in which questions and/or requests for feedback are appropriate.

- Pre-Submissions (Pre-Subs)

The purpose of a pre-submission meeting is to ask and obtain answers to your questions directly from the FDA. For all the feedback, you can always follow up and have additional feedback from the FDA after receiving an initial response to Pre-Submission.

  • Premarket Submission (IDE, PMA, HDE, De Novo Request, 510(k), Dual, BLA, IND)

  • Accessory Classification Request

  • CW submission

* Note: FDA review of Pre-Sub does not guarantee approval for your future premarket notifications.

- Study Risk Determinations

FDA is available to help you, clinical investigator, and IRB in making the risk determination.

A Study Risk Determination is a request for FDA determination for whether a planned medical device clinical study is significant risk (SR), non-significant risk (NSR), or exempt from IDE regulations as defined by the IDE regulations. [21 CFR part 812]

- Informational Meetings

An Informational Meeting is a request to share information with FDA without the expectation of feedback. This information sharing can be helpful in providing an overview of ongoing device development (particularly when there are multiple submissions planned within the next 6-12 months) and familiarizing the FDA review team about new device(s) with significant differences in technology from currently available devices.

You can also request feedback through the Q-Sub regarding the development of a Medical Device Development Tool, recognition of publicly accessible genetic variant databases, Combination product agreement meetings (CPAM), and compliance actions.

In addition to the Q-Sub types listed above, the Q-Sub program provides a mechanism to track interactions described in other FDA program guidance documents. Currently, in addition to the Q-Sub types above, the interactions that are tracked in the Q-Submission program include the following :

• PMA - Day 100 Meetings

• Agreement and Determination Meetings

• Submissions associated with the Breakthrough Device Designation Request, Safer Technologies Program ("STeP")

• Accessory Classification Requests

General Q-Submission Considerations

1. Relating Q-Submissions to Future IDE, IND, CWs, and Marketing Submission(s) (“Related Submission(s)”) Many Q-Subs are followed by marketing submissions, IDEs, INDs, CWs, and/or supplementary Q-Sub interactions. These follow-on submissions are considered “related submissions” if they are for the same device and indications for use as the original Q-Sub. To help link Q-Subs to their subsequent related submissions, the submitter should identify the relevant Q-Subs in the cover letter of the subsequent related submission. If the relevant QSubs are not identified in the cover letter of the subsequent related submission, they will not be linked in FDA’s records. Therefore, there may be a delay in determining FDA’s previous feedback, and the subject device may not be incorporated in any future analyses of Q-Sub program effectiveness.

In addition, the related submission should include a section that clearly references the previous communication(s) with FDA about the subject device (or similar device) and explains how any previous feedback has been addressed within the current submission. This discussion of previous feedback will streamline FDA review even if the submitter elects to address FDA feedback with alternative methods to those discussed during the previous interactions.

2. Combination Product Considerations Requests for meetings regarding a combination product should be submitted to the lead center for the product, in accordance with that center’s corresponding processes. Accordingly, Q-submissions should only be submitted for device-led combination products assigned to CDRH or CBER.

If the classification or center assignment for a medical product is unclear or in dispute, the submitter should submit an RFD or Pre-RFD to OCP, and then submit their meeting request to the center determined to be the lead center. If CDRH or CBER receives a Q-Sub for a combination product as the lead center for the product, the center’s staff intends to notify the other center(s) involved in the review of the combination product of its receipt and include the appropriate review staff from these other center(s) to ensure that the entire combination product review team is aware of the questions from the submitter and engaged, as needed, in providing comprehensive and aligned feedback.

When Q-Subs for combination products are submitted, FDA intends to initiate the same review process for the Q-Sub as for single-entity devices.

A well-formed and clear summary of information being submitted within the stipulated time to product-related questions is the primary key in the Q-Sub meeting with the FDA.

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