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What are some types of interactions that fall outside of the 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.

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.

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