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What are some other types of Q-Submissions?
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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

In addition to Pre-Subs, SIRs, Study Risk Determinations, and Informational Meetings, the Q-Sub program provides a mechanism to track interactions described in other FDA program guidance documents. Currently, the interactions that are tracked in the Q-Submission program include the following:

1. PMA Day 100 Meetings

2. Agreement and Determination Meetings

3. Submissions associated with the Breakthrough Devices Program:

  • Designation Request for Breakthrough Request: to request inclusion in the Breakthrough Devices Program according to the criteria specified in Section 515B(b) of the FD&C Act.
  • Interaction for Designated Breakthrough Device: to request feedback on device development and clinical protocols for devices previously designated as breakthrough.

4. Accessory Classification Requests:

  • For an Existing Accessory Type: to request appropriate classification of an accessory that has been granted marketing authorization as part of a premarket submission for another device with which the accessory is intended to be used.
  • For a New Accessory Type: to request appropriate classification of an accessory that has not been previously classified under the FD&C Act, cleared for marketing under a 510(k) submission, or approved in a PMA. New Accessory Type classification requests should be submitted together with the premarket submission for the parent device. Accessory Classification Request will be tracked as a Q-Sub with review and decisions being conducted concurrently with the parent premarket submission.

Policies and procedures for these other Q-Sub types can be found in their respective guidance documents. Further, as FDA works to create additional mechanisms to streamline the device development and review process, FDA may create additional Q-Sub types that follow the same principles and processes outlined in this guidance document.

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