Pre-submission process is used by applicant to obtain feedback from FDA before actual submission for the 510(k) clearance. A formal written application, including a covering letter with details of the device and submitter, premarket review submission cover sheet (Form 3514), specific questions and the type of requested feedback, should be sent to FDA. The response provided by FDA is generally written. But if required, face-to-face meeting or teleconference may also be requested.
This program can be used to inform the FDA review team about the specifics of the device and also to understand the potential hurdles to be crossed for the clearance. The advice provided by FDA is binding, until changes in circumstances makes the advice void. Additional comments may also be provided along with the response to the queries. Better quality of the subsequent 510(k) application, smoother review and shorter review times are some of the benefits of this program. Also, this process is free of any charges.
What all situations we can apply the presubmission Program? Is the FDA Q-submission and pre-submission are same?