Mastering FDA Pre-Submission (Q-Sub): A Strategic Edge for Medical Device Innovators

There is always uncertainty baked into any government submission process, and companies benefit when they can resolve issues before filing a 510(k).

The FDA Pre-Submission program lets sponsors request feedback on planned medical device, biologic, or drug submissions. It is a helpful service, yet it remains underused.

What is the Pre-submission?

Pre-Submission allows you to ask for formal FDA feedback before you file a 510(k). This request is part of a Q-Submission, which, under FDA guidance, may include:

• Pre-Submission (our focus here)
• An informal meeting
• An agreement meeting
• Other (submission issues or study risk determinations)

The program was created to broaden early access to the FDA so sponsors can address questions in advance, potentially shortening the path to market.

Instructions appear in the FDA document Requests for Feedback on Medical Device Submissions. Combination products (e.g., drug-eluting stents, drug-device inhalers) may follow additional steps outlined in Guidance for Industry.

In short, a Pre-Submission is a formal written request for FDA feedback provided as a written response, meeting, or teleconference; the discussion is captured in meeting minutes.

It offers a chance to raise key issues early and can simplify later submissions.

FDA continues to expand the program; the full family of early-interaction requests is called Q-Submissions (Q-Subs). They may precede:

• Investigational Device Exemption (IDE)
• Premarket Approval (PMA)
• Premarket Notification 510(k)
• Dual submission
• Humanitarian Device Exemption (HDE)
• De Novo request
• CLIA Waiver
• Certain Investigational New Drug Applications (IND) and Biologics License Applications (BLA)

Benefits of the Pre-submissions

Should I use a Pre-Submission? Sponsors weigh several factors; common advantages include:

Further reading:

• U.S. FDA official site

• You build a collegial relationship with the FDA. Reviewers are people too, and they like to know who is behind the device.
• You can surface and resolve unknowns early, confirming assumptions before the full submission.
• You receive no-cost guidance that can shape both technical development and regulatory strategy.
• Occasionally the FDA offers an extra review of Pre-Submission materials—an informal “bonus round” that can yield useful feedback well before the 510(k) is filed.

Remember: a Pre-Sub is not a final acceptance; that decision comes only with the actual submission. Still, the early preview is almost always worthwhile.

Cons of the Pre-submission

Time and money matter. A consultant typically charges $5,000–$25,000, and if all milestones are met the FDA cycle runs about 60–75 days.

A common worry: “What if FDA tells us ‘no’ and asks for extra studies X, Y, and Z?”

Our answer never changes: isn’t it better to learn that now? The same issue will surface in the 510(k) regardless, so discovering it early saves months of rework.

These drawbacks help explain why the pathway is underused, yet FDA openly encourages Pre-Subs because they raise the quality of later submissions.

Conclusions

The Pre-Submission program is an under-utilized tool. Companies sometimes skip it fearing added cost, longer timelines, or unexpected requests. In our experience, the investment pays off. Like many device manufacturers, we keep an open dialogue with FDA and find the early conversation well worth the effort.

FDA official site