FDA Guidance on the Q-Submission Program

By Beth Loring & Hannah Cutright

On June 2, 2023, the FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) released a new guidance document titled “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.” The Q-Submission (Q-Sub) Program provides medical device manufacturers the opportunity to engage in discussions with FDA review teams during the product development process.

This guidance came from CDRH and CBER, but not from CDER. This is surprising because we are used to seeing guidance documents come either from CDRH or CDER/CBER combined. Regardless, there was a great deal of important and interesting information published. Check out below for some of our take-aways and a submission details.

Interesting Take-aways:

History of the Q-Sub Program

• When it was established in 1995, the Pre-Submission Program was intended for Investigational Device Exemptions (IDEs) only, but it was modified in 2012 to include all types of premarket submissions.

• In 2014, the Pre-Submission Program was renamed the Q-Submission Program, establishing a method for the FDA to manage all types of interactions with medical device manufacturers.

  • It's called the "Q-Sub" Program because submissions to CDRH are assigned a number starting with “Q” followed by two digits representing the year, and four digits representing the order in which the request was received during that year.

  • Similarly, submissions to CBER are assigned a “BQ” number.

Types of Q-Sub Requests

Using the Q-Sub Program

More about Pre-Subs

What to Expect

Below, you'll find specific details on how to submit a request for feedback or a meeting through the Q-Submission program.

Submission Details:

What should a cover letter include?

• Contact Information

• Q-Sub Type

• Method of Feedback

• Meeting information

• Purpose of Q-Sub

• Device or Product Description

• Proposed Indications for Use or Intended Use

• Regulatory History

What info should be included in each type of submission?

How long does it take to hear back from the FDA?

Checklist and document examples

Table 1: Feedback Methods and Timeframes for Each Q-Sub Type

Conclusion

Q-Submissions are voluntary but important opportunities to share information and receive input from the FDA before a final marketing submission, IDE, or IND. The Pre-Sub Program can be especially valuable for devices that involve novel technologies or pose significant risks. Although some manufacturers prefer to keep a “low profile” regarding the FDA, our most successful clients are those who take full advantage of the Q-Sub Program and communicate with the Agency proactively to de-risk their final submissions, ultimately shortening time to market.

Update - September 6, 2023

Starting October 1, 2023, all 510(k) submissions, unless exempted, must be submitted as electronic submissions using eSTAR, as noted in the:

Electronic Submission Template for Medical Device 510(k) Submissions final guidance.

eSTAR is the only available electronic submission template to facilitate the preparation of 510(k) electronic submissions. You can learn more here on the FDA website.