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What information should be included in a Q-Submission?
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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

To ensure appropriate log in and to facilitate review of a Q-Sub, the following should be included in a Q-Sub Cover Letter. Please be advised that your Q-Sub should be written in the English language.

Contact Information

Company name, address, and contact person(s) including title(s), phone number(s), fax number(s), and email address(es). Note that contact information should be provided for the submitter as well as the correspondent (e.g. consultant), if different from the submitter.

Q-Sub Type

Indication of which Q-Sub type is being requested. Note that only one Q-Sub type should be included in each submission. If a Q-Sub type includes the option for a meeting (e.g. a Pre-Sub, SIR, and Informational Meeting requests), please indicate the following to facilitate scheduling:

  • A draft agenda proposing the topics to be presented and the estimated time for each agenda item, to the extent possible pending FDA feedback
  • The meeting format you are requesting (i.e. in-person or by teleconference)
  • Three (3) or more preferred dates and times when you are available to meet
    - While you should propose dates that suit your schedule, please keep in mind that FDA needs sufficient time to review the material submitted, hold internal discussions if needed, and identify a meeting time when the necessary team members are available.
    - If your proposed dates do not allow for adequate preparation, FDA may not be able to accommodate your requested dates and will offer you alternative dates within an appropriate time frame.  
  • The planned attendees, including each attendee’s position, or title, and affiliation.
    - If you have not yet identified all of your attendees, you should indicate the type of subject matter experts you plan to invite.
    - FDA recommends that submitters identify in their cover letter any appropriate FDA staff that are requested to attend the meeting if specific expertise may be needed (e.g. staff from other Centers).
The following should be easily identified within the Q-Sub:
  • Purpose. The overall purpose of the Q-Sub including goals for the outcome of the interaction with FDA.
  • Device or Product Description. An explanation of how the device functions, the basic scientific concepts that form the basis for the device, and the significant physical and performance characteristics of the device. A brief description of the manufacturing process should be included if the manufacturing process may affect safety and/or effectiveness and may therefore impact FDA’s recommendations regarding device testing. The generic name of the device as well as any proprietary name or trade name should be included. Images, videos, and more detailed information may be included as appropriate in the submission itself.
  • Proposed Indications for Use or Intended Use. Include a description of the disease(s) or condition(s) the device will diagnose, treat, prevent, cure or mitigate, and a description of the patient population for which the device is intended.
  • Regulatory History. Listing of any relevant previous communications with FDA about the subject device including but not limited to any marketing submission, IDE, 513(g), and/or Q-Sub application numbers relevant to the subject Q-Sub. The submission should also include a brief summary of these previous FDA interactions and submissions (and submission number(s)), including feedback received and resolution of that feedback (or justification of alternative paths) as applicable.

Use of the CDRH Premarket Review Submission Cover Sheet for submissions made to CDRH or CBER is highly recommended to facilitate correct login and prompt routing to the appropriate review group.

You must submit an eCopy of your Q-Sub under section 745(A)(b) of the FD&C Act. The FDA review clock starts when a valid eCopy is received; however, for Q-Subs that utilize an acceptance review, if a file is placed on hold, the review clock will begin upon receipt of the amendment that is accepted for review.  

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