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What are some uses of the Informational Meeting Q-Submission program?

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About the Author
Proxima CRO Team
Isabella Schmitt, 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.

Note that there are interactions that do not meet the definitions of the general Q-Sub types and for which a new formal Q-Sub type has not been created. When a new Q-Sub type does not exist to track a particular type of interaction, FDA may use the Informational Meeting Q-Sub type as a vehicle to track those interactions. Examples of the types of interactions for which the Informational Meeting Q-Sub vehicle is currently used for tracking include:

  • Request for FDA feedback on specific questions or cross-cutting policy matters (e.g. submission strategies unrelated to a specific premarket submission, preclinical testing strategies from third party testing labs) from other government agencies, non-profits, trade organizations and professional societies. Note that a submission is not necessary for FDA to meet with these groups, but is open to accepting them, should organizations voluntarily submit information in advance of the meeting for FDA’s substantive review.
  • Request for feedback regarding development of a Medical Device Development Tool.
  • Request for recognition of publicly accessible genetic variant databases.
  • Request for FDA feedback on design elements of a clinical study that do not fall within the scope of a Pre-Submission, and therefore would not be eligible for discussion under a Pre-Sub. These requests could include requests regarding study design for an NSR or IDE exempt study for which the results are not intended to support a future IDE or marketing submission.
  • Combination product agreement meetings (CPAM) as defined under section 503(g)(2)(A) of the FD&C Act.

Generally, Informational Meetings are intended for a submitter to provide information to FDA without the expectation of feedback from FDA. However, when Informational Meeting Q-Subs are used for tracking purposes in situations when a formal Q-Sub type for that interaction has not been created, feedback may be provided as prescribed by the program for which the Informational Meeting Q-Sub type is being used.

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