Contains Nonbinding Recommendations
3
processes are covered in separate guidance documents (see Sections III.E and F of this
guidance). Finally, there are other interactions with FDA that are outside the scope of the Q-Sub
program (Section III.G of this guidance).
A. Pre-Submissions (Pre-Subs)
A Pre-Sub includes a formal written request from a submitter
for feedback from FDA that is
provided in the form of a formal written response or, if the submitter chooses, formal written
feedback followed by a meeting. All discussion that occurs during the meeting is documented in
meeting minutes that are drafted by the submitter and submitted for FDA review.
A Pre-Sub provides the opportunity for a submitter to obtain FDA feedback prior to an intended
premarket submission (i.e., IDE, PMA, HDE, De Novo request, 510(k), Dual, BLA, IND),
Accessory Classification Request, or CW. The request should include specific questions
regarding review topics relevant to a planned IDE, CW, or marketing submission. Some
examples of common review topics are biocompatibility, bench testing, cybersecurity, etc. See
Appendix 2 for examples of specific questions within review topics. A Pre-Sub is appropriate
when FDA’s feedback on specific questions would help guide product development and/or
submission preparation, but is not intended to be a pre-review of an intended submission or a
pre-review of data to be provided in a submission.
The program is entirely voluntary on the part of the submitter. However, early interaction with
FDA on planned non-clinical and clinical studies and careful consideration of FDA’s feedback
may improve the quality of subsequent submissions, shorten total review times, and facilitate the
development process for new devices. FDA believes that interactions provided within Pre-Subs
are likely to contribute to a more efficient and transparent review process for FDA and the
submitter. Our staff develops feedback for Pre-Subs by considering multiple scientific and
regulatory approaches consistent with least burdensome requirements and principles
, to
streamline regulatory processes. FDA has found that feedback is most effective when requested
prior to execution of planned testing. Issues raised by FDA in a Pre-Sub do not obligate
submitters to addressing or resolving those in a subsequent submission, though any future
submission related to that topic should discuss why a different approach was chosen or an issue
left unresolved. Further, review of information in a Pre-Sub does not guarantee a favorable
decision in future submissions. Additional questions may be raised during the review of the
future submission when all information is considered as a whole, or if new information has
become available since the Pre-Sub.
Pre-Subs can be useful to obtain FDA feedback on a wide variety of future submission types,
including other Q-Submission types that you intend to submit requesting an FDA decision. One
For the purposes of this guidance document, manufacturers or other parties who submit an IDE, IND, CW, Dual,
or marketing submission to the Agency are referred to as submitters.
See FDA’s guidance, “The Least Burdensome Provisions: Concept and Principles,” available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/least-burdensome-provisions-concept-
and-principles and sections 513(i)(1)(D)(i), 513(a)(3)(D)(ii), 515(c)(5)(A), 515(c)(5)(C), 513(a)(3)(D)(iii),
513(i)(1)(D)(ii), and 515(c)(5)(B) of the FD&C Act.