About the Author
Proxima CRO Team
Isabella Schmitt, MBA, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

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.

Related FAQs:
More Questions? We're here to help!