This post is brought to you by 3D Communications
As someone who spent the last seven years working at the Center for Devices and Radiological Health (CDRH), I can tell you that the underlying relationship between a company and its review division really matters – from submission, through a potential Advisory Committee meeting, and beyond. Taking the time to develop a good relationship with FDA, and doing it in a strategic way, can make the difference between a relatively smooth path to approval or a long, frustrating road ahead.
The great news is that CDRH is increasingly focused on being more interactive with industry and working with company teams. As a result, companies now have more opportunities and programs than ever to improve their relationship with their regulator. Some of these programs are well-known, but others are among the best kept secrets in the industry; and all of them can be important for a better review process.
Because many of these interactions are specifically designed to help 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 be later used to the company’s benefit or detriment!
Here is a list of programs that companies can access throughout the product lifecycle and some specifics on the meetings that could make a major difference to a product’s future.
CDRH’s Experiential Learning Program (ELP)
One of the newer programs at FDA is the Experiential Learning Program, or ELP. The ELP is designed to give regulators a more in-depth behind-the-scenes look at companies and their device design and innovation. Getting involved with the program begins by reviewing the areas of interest that FDA identifies and posts on the ELP website. If companies’ interests align with those identified by FDA, they can submit an application to the agency, via email, on the product or process they would like to showcase. Then FDA reviews the applications and determines which ones to approve based on their staff training priorities and available funding. The companies that are 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. The best part about the ELP program is that the team can interact with FDA, get to know their reviewers and vice-versa, and hopefully forge a more collegial relationship. I have attended multiple ELP visits, and they were all extremely valuable in building relationships with the companies and gave me and other reviewers insights into the company’s 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 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. Also, it’s important to 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. More information on ODE Vendor days can be found here.
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.
Companies are usually very familiar with Pre-Submission meetings, which should be used to get answers to specific questions about upcoming submissions. These meetings can help ensure a company is on the right track before submitting an application. Meeting in-person with FDA is always ideal for additional “facetime” 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 they can minimize any contentious issues during the official review. Pre-submission meetings can be held before submitting any type of application, whether it is an IDE, PMA, De Novo, HDE, or 510(k).
While companies are usually very familiar – and prepare for – Pre-Submission meetings, that isn’t always the case with other Q-Sub meetings, such as Informational Meetings. Failing to prepare for these meetings is a missed opportunity because Informational meetings can be leveraged to familiarize FDA’s review team about 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. This type of interaction helps the team better understand the device functionality and capabilities instead of having to rely on the written description 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 pre-clinical testing to FDA vs. at a Vendor Day because other companies won’t be there to see it.
An Informational meeting can also be a great way to give FDA a heads-up about an upcoming submission. I have seen first-hand 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 earlier in the review process is better, as they provide reviewers with a good overview of the company strategy across multiple submissions.
As with the previous meetings I described, 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 facetime with FDA can often lead to better relationships, these meetings can also be held via teleconference.
More information on Informational and Pre-Submission meetings can be found here.
The bottom line? Companies have many opportunities to communicate with CDRH long before submitting a device application. Understanding the purpose of these meetings -- and taking advantage of them -- can help educate reviewers about the device and program, minimize FDA questions later in the submission process, and cultivate a positive relationship, potentially leading to a smoother review process.