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.