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

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

 

 

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:

 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.

 

  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

 

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/ucm370879.htm,

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 https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm