The FDA published the guidance document Medical Device Submission Feedback and Meeting Requests: Q Submission Program in 2019, but it took the industry to understand all aspects of the program. This guidance covers a wide range of FDA submissions, including IDE / PMA / HDR applications, de novo requests, 510 (k) submissions, and CLIA exemptions. Given this wide range, it is useful to look at the various options in the Q-Sub program.

Type of Q submission

Let’s understand the different types of Q Sub Meeting.

Pre-submission request: Pre-Sub is a request to the FDA to provide feedback on specific questions related to a planned submission. This option is ideal for manufacturers who have questions about product development. The submitter must provide sufficient relevant background and supplementary information so that the FDA can provide feedback on the question.

The FDA hopes to provide written feedback while Q Sub Meeting may continue to improve the quality of subsequent submissions by submitters, reduce total review time, and accelerate the process of developing new devices.

Request for submission issues: This option is best suited for manufacturers who have received a marketing submission hold letter (e.g. Need additional information for 510 (k) or De Novo requests, Critical flaw for PMA and HDE. Or not approved). Submitters can use SIR to resolve or clarify issues in these letters quickly.

Study risk determination: Determining research risk is easy. It is the FDA’s request to determine whether a planned medical device clinical trial is a significant risk, a non-critical risk, or exempt from IDE regulation.

Information conference: Information conferences are unique because they do not involve feedback from the FDA. It’s just a request to share information with the FDA. This option, with multiple submissions planned for next year, is best suited for manufacturers who want to be familiar with the FDA about new devices and unique technologies.

Other Q-submission types: The following submissions will be tracked by “Q” number and technically submitted under the Q-Sub process, but will have their own separate guidance document: PMA Day 100 Conference, Agreement and Decision under FDAMA Meetings, breakthrough device program submissions, and accessory classification requests.

How to Submit Q-Sub Request?

Multiple Requests: Some manufacturers using the Q-Submission Program may find that they have submitted multiple requests to the FDA. This is allowed (as long as only one Q-Sub is submitted at a time), but it is best to create a first cover letter that describes all expected submissions on the same device.

Relevant Submissions: For later marketing submissions, the submitter must identify the previous Q-Sub in the cover letter and “explain how the previous feedback was addressed within the current submission”. There is.

Highlights of content to submit:

. Indicates what type of Q-Sub is required
. Provides agenda for Q Sub Meeting with the FDA (clarifies the purpose or goals of the Q-Sub)
. Describe the device, suggested indications for use, and intended patient population
. Please explain your device’s regulatory history (previous marketing submissions or contact with the FDA regarding your device)

Conclusion: The guidance states that future submissions on topics that deviate from what was discussed in the pre-sub need to discuss why a different approach was chosen or why the problem remains unsolved.