Understanding the Q-Sub Guidance

Do you understand the Q-Sub Guidance?

The FDA issued the guidance document Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program in 2019, but it has taken some time for the industry to understand all the facets of the program. The guidance covers a wide range of FDA submissions – IDE/PMA/HDE applications, de novo requests, 510(k) submissions, CLIA waivers, and more. Given this broad scope, it is helpful to look at the different options under the Q-Sub Program.

Types of Q-Submissions

  1. Pre-Submissions. A Pre-Sub is a request for the FDA to give feedback on specific questions relevant to a planned submission. This option is most appropriate for manufacturers with questions about product development (be sure to ask before execution of planned testing!) or submission preparation. The submitter should give plenty of relevant background or supporting information so the FDA can develop feedback to the questions – and the questions should not address more than 3 or 4 substantial topics.
    The FDA will give written feedback (which could be followed by a meeting) which will hopefully improve the quality of the submitter’s subsequent submissions, shorten the total review time, and facilitate the development process for new devices. Manufacturers should note that their Pre-Sub questions are not forgotten by the FDA – the guidance says that any future submission on the topic which deviates from what was discussed at the Pre-Sub “should discuss why a different approach was chosen or an issue left unresolved.”
  2. Submission Issue Requests. A SIR is a request for FDA feedback on a proposed approach to address issues conveyed in a marketing submission. This option is most appropriate for manufacturers who received a marketing submission hold letter (ex: “Additional Information Needed” for 510(k)s or De Novo requests; “Major Deficiencies” or “Not Approvable” for PMAs and HDEs). The submitter can use a SIR to quickly resolve or clarify issues in these letters. However, a SIR should not be used to discuss letters conveying final decisions.
  3. Study Risk Determination. A study risk determination is straightforward. It is a request for the FDA to determine whether a planned medical device clinical study is a significant risk, non-significant risk, or exempt from IDE regulations.
  4. Informational Meeting. An informational meeting is distinctive because it does not entail feedback from the FDA; it is simply a request to share information with the FDA. This option is most appropriate for manufacturers who have multiple submissions planned for the coming year, and who wish to familiarize the FDA about their new device(s) and unique technology.
    It is worth noting that the Informational Meeting is also a sort of catch-all for other uses of the Q-Submission Program: it can include a request for FDA feedback on cross-cutting policy matters, request for feedback on development of MDDT, combination product agreement meetings, and more.
  5. Other Q-Submission Types. The following submissions are tracked with a “Q” number and technically submitted under the Q-Sub process, but they have their own, separate guidance documents: PMA Day 100 Meetings, Agreement and Determination meetings under FDAMA, Breakthrough Devices Program submissions, and Accessory Classification Requests.

Filing a Q-Sub Request: Tips

  • Multiple Requests: Some manufacturers utilizing the Q-Submission Program may find themselves submitting multiple requests to the FDA. That is allowed (as long as only one Q-Sub is submitted at a time), but it is best to develop an initial cover letter that explains all of the expected submissions for the same device.
  • Related Submissions: In a later marketing submission, the submitter should identify the previous Q-Sub in the cover letter and “explain how any previous feedback has been addressed within the current submission.”
  • Highlights of the content for a submission:
    • Indicate which type of Q-Sub is being requested
    • Provide a draft agenda for the meeting with the FDA (make the purpose or goals of the Q-Sub clear)
    • Describe the device, proposed indications for use, and the intended patient population
    • Describe the regulatory history of the device (any previous marketing submission or communication with the FDA about the device)

See our previous Q-Sub post here: FDA Final Guidance Q-Submission Program

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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