FDA New Guidance on Q-Submission Meetings for Devicemakers- Q-submission process

  • By: Staff Editor
  • Date: June 11, 2018
  • Source:
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On June 7 2018 FDA has released new draft guidance related to meetings devicemakers may request under the agency’s Pre-Submission Program — it is also known as Q-submission meetings as the agency assigns applications a Q number.

The term “Q-Submission” or “Q-Sub” refers to the system used to track the collection of interactions These are important opportunities for submitters to share information with FDA and receive input outside of the submission of an IDE, IND, marketing submission, or CW. The interactions tracked in the Q-Sub program may be used at different points along the total product life cycle for a device and are voluntary.
The draft guidance covers various categories of device-related submissions, - IDE, PMA, HDE, De Novo request, 510(k), Dual,
 BLA, IND , humanitarian device exemptions. it also applies to pre-submission feedback and certain INDs.
What is Q-Sub program ?
The general processes for the Q-Sub program are outlined below, including submission tracking and meeting logistics as well as recommended content and timelines for each Q-Sub type
1. SubmissionContent 
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), 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 a particular 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:
  1. A proposed agenda describing the topics to be presented and the estimated time for each agenda item;
  2. The meeting format you are requesting (i.e., in-person or by teleconference; see Section 3.a. below);
  3. Three (3) or more preferred dates and times when you are available to meet.
 a) 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.
b) 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 timeframe. Please refer to the timelines for Pre-Subs (see Section 4.a.2 ), SIRs (see Section 4.b.2 ), and Informational Meetings (see Section 4.d.2 ) in considering proposed dates that are likely to be accepted by FDA.
  • 4.The planned attendees, including each attendee’s position, or title, and affiliation.
  •   a) If you have not yet identified all of your attendees, you should indicate the type of subject matter experts you plan to invite. 
     b) FDA recommends that sponsors 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. including description of the disease(s) or condition(s) the device will diagnose, treat, prevent, cure or mitigate, including 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 itself should also include a brief summary of these previous FDA interactions and submissions, 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. For more information on eCopy and the submission process, please refer to
    including the guidance entitled “eCopy Program for Medical Device Submissions.” In addition to the eCopy guidance, for Q-Subs for products regulated in the Center for Biologics Evaluation and Research (CBER), additional information regarding electronic submission can be located at the following website

    Click here to download the file
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