How to Maximize Early FDA Interactions and Improve Your Chances of Medical Device Approval
by Jamie Page
The underlying relationship between your company and its review division really matters – from submission through a potential Advisory Committee meeting to your medical device approval. Taking the time to develop a good relationship with the FDA – and doing it strategically – can mean the difference between a relatively smooth path to medical device approval or a long, frustrating process.
The great news is that the Center for Devices and Radiological Health (CDRH) is increasingly focused on being more interactive with industry and working with company teams. As a result, companies have more opportunities and programs to improve their relationship with their regulator. Some of these programs are well known; others are among the best-kept secrets in the industry; and all of them can be important for a better medical-device approval review process.
Because many of these interactions are specifically designed to help the CDRH gain information about the company and device, they can be less structured, allowing for more collegial conversation. However, it is important to be strategic and prepared in ALL meetings with the FDA. What is said during ANY FDA meeting is “on the record” and can later be used to the company’s benefit or detriment.
Here’s a list of programs you can access throughout the product life cycle and some specifics on the meetings that could make a major difference to a product’s future and the chances for medical device approval.
CDRH’s Experiential Learning Program (ELP)
The ELP is designed to give regulators a more in-depth, behind-the-scenes look at companies and their device design and innovation. Begin by reviewing the FDA areas of interest posted on the ELP website. If your interests align, you can submit an application to the agency on the product or process they would like to showcase. Then the FDA reviews the applications and determines which ones to approve based on their staff training priorities and available funding.
The companies selected choose the day’s agenda. For example, a company can take regulators through their design process, tour their manufacturing site, or visit a hospital where their device is being used. Your team can interact with the FDA, get to know their reviewers and vice versa, and forge a more collegial relationship. I have attended multiple ELP visits and they were all extremely valuable in building relationships and gave me and other reviewers insights into the company’s medical-device approval processes, helping us connect the dots between the review application and how the device was made and used.
Office of Device Evaluation (ODE) Vendor Days
While Vendor Days may be better known to industry than the ELP, they may not provide the exposure to the FDA that sponsors want because reviewers may not attend due to their busy schedules. During Vendor Days, which take place throughout the year, multiple companies come together on the FDA campus to demonstrate their devices. The goal is to help FDA reviewers get hands-on experience with devices and allow them to ask questions about the products on display. One effective approach that I have seen companies use to maximize this meeting is to simply contact their reviewer in advance to let them know that they are attending and to ensure – or persuade – the review team to be there. While companies won’t be able to ask specific questions about their submission, they can have a more personal conversation with their regulator and get to know each other better. Note that since other companies are showcasing their devices at the same time, it may be best to keep products in early development at home.
Q-Submission (Q-Sub) Meetings
Unlike the public Vendor Days, the Q-Sub program is a way to get private, one-on-one face time with reviewers. While there are many types of Q-Sub meetings, the most important for early review are informational or pre-submission meetings.
Pre-submission meetings help ensure a company is on the right track before submitting an application. Meeting in-person with the FDA is ideal for additional face time and relationship building, but companies can also get FDA feedback by email or teleconference. Pre-submission meetings help reviewers become more familiar with a device and its development, and can minimize any contentious issues during the official review. Pre-submission meetings can be held before submitting any type of application, whether an Investigational Device Exemption (IDE), Premarket Approval (PMA), De Novo, Humanitarian Device Exemption (HDE), or 510(k).
Informational meetings can be leveraged to familiarize the FDA’s review team with ongoing device development or present new devices that have significant differences in technology. Informational meetings are less structured and allow companies to showcase the capabilities of their novel devices – demonstrating to the review team how the device works instead of relying on written descriptions and drawings later in the submission. Therefore, it’s best to schedule these meetings before submitting an IDE. Informational meetings are also a great way to introduce a device in preclinical testing to FDA versus at a Vendor Day because other companies won’t be there to see it. Informational meeting can also be a great way to give the FDA a heads up about an upcoming submission.
I have seen firsthand the practical benefits when companies let the agency know they have a submission planned, which helps the agency better manage schedules. The result is often a more efficient review team, fewer review delays, and the relationship building that comes with good communication. Another purpose of informational meetings is to brief reviewers when companies have multiple submissions planned. As always, scheduling these meetings early in the review process is better, as they provide reviewers with a good overview of company strategy across multiple submissions.
Companies can’t ask for FDA feedback at informational meetings, but they are a good way to educate reviewers on the device and how it works. Again, this is much better than reviewers having to rely only on a written description and drawings in a large submission later. While face time with the FDA can often lead to better relationships, these meetings can also be held via teleconference.
The bottom line? To improve your chances of getting a medical-device approval from the FDA, talk to reviewers early and often. Don’t wait until you are about to submit a device application; there are plenty of ways to create or cultivate a relationship with your CDRH regulator long before that. Leveraging as many of these programs as possible may not result in a new BFF, but it can certainly help minimize FDA questions down the road and make your application review as efficient, smooth – and friendly – as possible.