Convergence: Think ‘win-win’ during early orientation meetings with FDA for digital health devices

PITTSBURGH — Is it worth agreeing to an early orientation meeting with the US Food and Drug Administration (FDA) about your medical device software?

Alex Cadotte, vice president of Digital Health, AI, and Radiology at MCRA, told attendees at the RAPS Convergence 2025 conference that an early orientation meeting can help applicants get ahead of potential issues that may arise during a submission by engaging with the FDA at an earlier stage in the process.

This is not a new process for FDA, as it has chosen to leverage informal review with applicants in the past for medical devices. With early orientation meetings, “digital health has kind of put a name to something that we would do occasionally when we were at the agency,” Cadotte said.

When applicants get an email from FDA asking about an early orientation meeting, “I’ve noticed some people get a little freaked out,” Cadotte said. However, he noted the meeting “is a great opportunity to interact with the agency.”

An early orientation meeting is different from other submissions and interactions such as a 513(g) request for information or requests for feedback and meetings under the Q-Submission (Q-Sub) program, Cadotte explained. Unlike a Q-Sub, where an applicant poses questions to FDA, an early orientation meeting is essentially a walkthrough tour of the device.

“I’d say it’s probably most similar to an interactive meeting,” he said.

Applicants should allocate enough time to review the device with FDA and communicate the amount of time they think the review will take with the agency. FDA is interested in learning about the device, and an applicant should include any relevant information, videos, and other materials in their early orientation meeting.

When preparing for the meeting, Cadotte encouraged attendees to “think win-win.”

“Think about things that are going to help you and also help the agency,” he said. “[I]f you are introducing a new technology to FDA, you also have the opportunity to help them better understand what you’re trying to do.”

During an early orientation meeting, it is important to think from the perspective of the lead review, anticipate questions the agency might have, and consider what they need to know about your submission. “This is really what this opportunity is about,” Cadotte said.

It’s also important to engage in conversation with the agency rather than hold back information. “I know there’s this idea of being strategic about what you're talking about. You should still do that, but really try to engage, because you’re kind of setting the tone for the rest of the submission,” he said.

There may also be opportunities to engage with the agency again after the early orientation meeting. Cadotte said applicants should “definitely offer to engage again if they feel like they need more information out of you.”

Through the whole submission process, communication is key, Cadotte added. Applicants should be proactive whenever possible. Cadotte said he used to tell his former FDA staff that 15 minutes on the phone could save 15 hours of review time. “That still holds very true for things like the early orientation meeting,” he said.

When in doubt, clarify. “I feel like 90% of deficiencies are based on miscommunication—what you want your device to do, what it actually does,” he said.

Regulatory Accelerator

FDA’s Center for Devices and Radiological Health (CDRH) recently launched its Regulatory Accelerator initiative that gathers together specific agency resources around the regulation of digital health technologies and digital health devices.

The Regulatory Accelerator consists of three components: a resource index for applicants with a visual guide of FDA tools, opportunities for engagement, and relevant guidance documents; a medical device software guidance navigator to help applicants find relevant FDA guidances for their submission; and the early orientation meeting program.

The goal of the accelerator is to create “opportunities for alignment and collaboration across the digital health ecosystem, and to promote and increase digital health literacy,” MiRa Jacobs, division director for the division of digital health policy at the digital health center of excellence at FDA’s CDRH, told attendees.

“The accelerator helps to advance safe and effective medical device software by enhancing collaboration and understanding between innovators and the FDA, and it's meant to support efficiency and transparency on the often complex journey of bringing a device to market,” she explained.

Jacobs acknowledged that while these resources had already existed at FDA, “we’re seeing a real diversity of folks coming and submitting, especially in the digital health space these days, and it can be really hard to identify the right place to start.”

“I think there's a lot of nuance for digital health devices in particular that you might not necessarily encounter with some traditional submissions,” she said.

The Regulatory Accelerator is there to remind applicants that digital health submissions at FDA have a lot of flexibility, resources, and approaches for bringing information to the attention of review teams in the best format possible, Jacobs noted.

“We put this resource together to really try and focus in on what folks that are coming from the digital health space might need, really emphasize what the agency has tried to do in a few different pockets to make sure that the experience can be made smoother for those folks, and hopefully make this just a more accessible way of reaching us,” she said.

RAPS Convergence

Convergence: Think ‘win-win’ during early orientation meetings with FDA for digital health devices

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