Frequently Asked Questions

What are some types of interactions that fall outside of the Q-Submission program?

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Compliance & Regulatory: MedTech

There are several other means by which industry may obtain feedback from FDA which are outside the scope of the Q-Sub Program, including, but not limited to, the following:

  • Teleconferences or emails with FDA staff (e.g. by the lead reviewer or Regulatory Project Manager (RPM) discussing general FDA policy, procedures, or simple review clarification questions.
  • Interactive review of issues identified while an IDE, IND or marketing submission is under active FDA review.
  • Requests for appeal meetings made to CDRH or to CBER.
  • Requests for Designation (RFD) or Pre-RFDs are submitted to the Office of Combination Products (OCP) when the classification of a medical product as a drug, device, biological product, or combination product, or the product’s Center assignment (or both), is unclear or in dispute.
  • Section 513(g) Requests for Information, which provide a means to obtain information regarding the class in which a device has been classified or the requirements applicable to a device under the FD&C Act. While the potential regulatory pathway for a device may be a topic of discussion in a Pre-Sub interaction, device classification is accomplished in accordance with section 513 of the FD&C Act.
  • Requests for feedback from FDA outside the Q-Submission process via other resources including, but not limited to CDRH Device Advice website, CDRH’s Division of Industry and Consumer Education (DICE), or CBER’s Manufacturers Assistance and Technical Training Branch.
  • Requests for clarification on device-specific guidance documents or voluntary consensus standards that are not related to a specific device in development.