Why the FDA Presubmission Is an Underutilized Tool

What you don’t know can definitely hurt you

Published: Monday, April 30, 2018 - 11:03

“I wish there was a way for the FDA to give me a heads-up about my stuff, prior to submission….”

That sentiment was really the basis behind the U.S. Food and Drug Administration’s (FDA) presubmission tool, as I was discussing recently with medical-device quality assurance and regulatory affiars expert David Amor during a webinar we did on the topic. There is always uncertainty baked into any kind of government submission process, and it’s helpful to companies if there is a way to tackle issues before submitting a 510(K).

The FDA presubmission is a way for companies to request feedback from the agency on potential and planned medical device, biologics, and drug submissions. It’s a great service to take advantage of, although we’ve found that it tends to get underutilized.

Let’s take a look at the process and why we think it should be taken up by more medical device companies.

What is the presubmission?

Presubmission allows you to request formal feedback on your medical device before you make the move to submit your 510(K). This is known as a “Q submission,” which under the FDA guidelines, allows you to request:

• Presubmission (what we’re focusing on here)
• An informal meeting
• An agreement meeting
• Other (such as submission issues or risk determinations)

The presubmission process was born out of a need to provide expanded access to the FDA and allow companies to get valuable feedback ahead of time. This can help to keep your company on track for getting your device to market as soon as possible: It helps to be aware of possible issues ahead of time and deal with them before final submission.

The guidance for presubmission is clearly laid out in the FDA document “Requests for Feedback on Medical Device Submissions.” If you happen to have a combination product (such as a stent that administers a drug, or an inhaler), then there may be other, similar processes that you must go through. The document to check out in that case is “Guidance for Industry.”

In any case, the basic definition of what a presubmission is remains the same. As Amor says, “It’s a great way to meet with the FDA, ask them some questions, then document that information for future use. It boils down to identifying key issues that are keeping you up at night, and making your overall submission process easier.”

In the medical device world, you can use presubmissions for:
• Investigation device exemptions (IDE)
• Premarket approvals (PMA)
• Premarket notifications (510(K))

Our focus here is that last one, the 510(K).

Pros of presubmissions

Should we really use a presubmission? This is a key question that companies often ask, so it’s important to understand the relative pros and cons. Here are some of the pros:
• You develop a “human” relationship with the FDA. They are, after all, humans themselves and want to know who you are.
• You can remove some of the risk element from your submission. You get asked about things you don’t know as well as confirm things that you think you do know.
• You can get “free advice” to help drive your development and regulatory strategy.
• Sometimes the FDA will request a review of presubmission materials, giving you a “bonus round” ahead of your 510(K) submission. This is a great opportunity to gain valuable feedback.

Note that you’re not getting a final acceptance at this stage; the FDA will never give you this until the actual submission. However, it’s well worth getting the early heads-up.

Cons of presubmissions

There’s always a money and time aspect. You’re looking at $5,000 to $25,000 to have a consultant help you with a presubmission. If all timelines are met, the typical process takes 60–75 days.

A con that is frequently raised is, “What if they tell us no and say we have to do X, Y, and Z instead of what we’re already doing?”

Our answer to this will always be the same: Isn’t it better to know about this now rather than go ahead with your 510(K) submission and find out then? The FDA will pick out that same issue regardless, so it’s a much better use of your time to have found out about it during a presubmission.

Perhaps these cons are a big part of the reason that the presubmission is underutilized, but I would strongly suggest that you don’t let them put you off using it. The FDA actively encourages medical device manufacturers to use the presubmission because doing so helps the overall quality of the final submission.

The business case for the presubmission

Amor has a great example of a client for which the presubmission process saved all sorts of hassles further down the track. That client had thought that its device was Class III, but the presubmission process led it to realize that the device was, in fact, a Class II.

If you’ve spent any amount of time dealing with the different classifications, you’ll know that Class III devices are the most complex and require much more stringent regulatory controls due to the higher level of risk. Had that client not gone through presubmission, it may have gone ahead with the higher level of testing and controls required by a Class III device, costing much more money and adding to the timeline before the device could get to market.

In this instance, the presubmission saved money and time for the client, but this could also work the other way around—where you think you’ve put in place all that is required but find that the FDA expects more. No one wants to have a submission rejected and have to start the lengthy process all over again.

Presubmissions help you to gain an idea of what the FDA is focusing on. Listen to the questions its agents are asking you and pay attention to any areas that are emphasized: These need to be down pat for your final submission.

In some companies, particularly those that are trying to fundraise from investors, a presubmission provides a demonstration of value for the investor. It’s easier to convince someone if you’ve already had your device checked out by the regulator that has the final say in authorizing it. Although the FDA won’t provide you with advice on your pathway to approval, it will provide you with informal guidance.

Another good situation for considering a presubmission is when you’re producing a new or novel device that the FDA needs familiarization with. Again, it’s about the FDA “getting to know you”—you can improve the quality of your submission and move the process along if the FDA already knows about you and is familiar with your new indication or technology.

Questions about planned nonclinical or animal studies, or questions about using data, are also good things to bring to a presubmission. Note here, though, that you shouldn’t be asking, “What testing do I need to do?” You want to be asking specific questions about the testing you already know you will be doing.

Final thoughts

The presubmission service is a valuable tool that tends to be underutilized. Perhaps companies are put off by the idea that the process will take some time and money, or they’re worried that the FDA will tell them they’re going to have to do something that they hadn’t already planned on. (News flash: The agency will do this during submission, anyway.)

Our position is that a presubmission generally makes good business sense. You have the opportunity to make yourself known to the FDA and can ascertain its position on things relevant to your submission.

Like many other companies, you just may find it’s worth the time and money.

About The Author

Jon Speer

Jon Speer is the founder and vice president of quality assurance and regulatory affairs at Greenlight Guru, a software company that produces the only medical device quality management software solution. Device makers in more than 50 countries use Greenlight Guru to get safer products to market faster. Speer has served more than 20 years in the medical device industry and helped dozens of devices get to market. As a thought leader and speaker, he regularly contributes to numerous industry publications. He is also the host of Global Medical Device Podcast.