How to sharpen up FDA medical device submissions and meetings
TSG’s VP and Principal of Medical Device Regulatory, Laurie Clarke, shares hints and tips on how to work more effectively with the FDA over medical device submissions.
When medical device companies make an application or submission to the Food and Drug Administration (FDA) a lot of thought goes into how to present the best case. However, it’s easy to get so caught up in the big picture of the device that smaller details get overlooked. This can result in unforeseen problems which stall progress.
Whether you’re working on Investigational Device Exemption (IDE), Premarket Approval (PMA), Premarket Notification (510(k)) or any of the other FDA applications, it’s important to pay attention to detail. Misuse of terminology or an erroneous decimal point can introduce uncertainty and sink an otherwise watertight submission. The same is true of meetings with the FDA; you generally have one hour to make your case, so it’s important to ensure presentations and demonstrations are as seamless as possible.
Ask the following questions before you hit send on an FDA submission or attend a meeting.
1. Has all documentation been checked?
Clarity and consistency should be the defining features of written FDA submissions. Keep the structure simple. As my own mentor said: "Tell them what you’re going to tell them, tell them, and tell them what you told them". I always encourage clients and colleagues to do the same.
While we’re on the subject of repetition, FDA submissions are not the place to show off your impressive vocabulary, especially if it introduces ambiguity. It’s far better to use the same word repeatedly when describing a device’s structure, function, or intended use than to use synonyms which may confuse matters. A busy reviewer is reading the submission, not your high school English teacher.
Make it easy for FDA reviewers to find what they need. Keep the document focused, use headings and hyperlinks between sections if it might be necessary to cross-reference different sets of information.
Finally, always allow time for proofreading before submission. Ideally, ask someone who hasn’t been closely involved to give the document a final check. Ask them to highlight any inconsistencies, or areas where the meaning isn’t clear, as well as fixing typos.
2. Has the presentation been rehearsed?
If you have the chance to meet with the FDA in person, make sure you maximize the opportunity. As with the documentation, clarity and focus are key. You’ll usually only have one hour to cover a lot of ground, so don’t take up valuable minutes with company history or credentials. Get straight to the point: explain what your device does, outline its medical applications, provide evidence that it’s safe and effective.
The end goal is for the FDA to understand your device and approve its use. So, think about what information they’ll need in order to do that, and convey it clearly.
It’s very tempting to take a physical device to face-to-face meetings to show how it works. But you need to exercise caution here. So many things can go wrong with live demonstrations, undermining the device itself and your credibility. A more effective approach could be to create a short video introducing the device and showing it in action.
Before the meeting, have a final run-through of the presentation and any supporting videos. If possible, set up a dress rehearsal – this is a great way to identify any issues that might otherwise trip you up on the day.
3. Has a trusted third party checked the details?
It’s always helpful to have an external perspective on FDA submissions and presentations.
Smaller medical device companies and start-ups might benefit from a seasoned professional to guide them through the process, especially if it is their first time meeting with the Agency. Larger companies may have mastered the art of successful meetings with the Agency, but they can still benefit from an impartial review and constructive advice.
It can also be useful to have someone come on board to ‘play the bad guy’, challenging and interrogating the submission. This can reveal problem areas or inconsistencies which may need further work or clarification. Choosing a partner with experience in FDA submissions and meetings can make a significant difference to the outcome. Involving them from an early stage in the process makes it more likely that issues are identified when there’s still plenty of time to rectify them.
Be prepared for further questions
When you’re compiling an FDA submission or preparing for a meeting, it can feel like there’s a lot at stake. The process is resource-intensive and often involves input from several people or teams. It’s not unusual to find that changes and additions are being made right up to the last minute, which increases the risk of mistakes or inconsistencies being introduced. If you plan for this from the outset, and put internal milestones in place, it helps ensure that adequate time is allowed for final checking and rehearsals.
Nevertheless, even the best, most carefully prepared submissions and presentations are still likely to provoke questions from the FDA. Don’t be discouraged by this – it is a normal part of the process. Gaining approval for a medical device isn’t easy, and nor should it be. Review the questions, take stock, and think about how to resolve them effectively. The important thing is to keep the process moving towards obtaining FDA clearance or approval.
Laurie Clarke previously worked as FDA partner at several large law firms in the US. At TSG, her knowledge of regulatory programs that affect medical devices enables her to offer expert counsel to companies that are developing new device concepts.
Get in touch at firstname.lastname@example.org to speak with Laurie and find out how we can support your company.