A Software Demo is Worth a Submission Full of Screenshots, But Is An Early Orientation Meeting Worth the Time?

On July 24, 2025, FDA released the Regulatory Accelerator, an initiative to help digital health sponsors bring their technology to market. New developers may want to bookmark this link as the initiative neatly corrals information in one place. For those who have been working in the space, most of the information is familiar.

The Regulatory Accelerator includes:

• Resource Index for Innovators, which compiles tools, engagement opportunities, and guidance throughout all phases of the total product life cycle and identifies those with associated fees,
• Medical Device Software Guidance Navigator, which represents an efficient method for identifying pertinent FDA guidance documents for medical device software development and marketing submissions, and
• Early Orientation Meetings, which are opportunities for sponsors to provide device demonstrations and/or an overview of the marketing submission and respond to questions from the FDA review team.

The Resource Index for Innovators may be of particular value to digital health innovators who are just starting their journey and learning about the different FDA submissions and programs. The index is a nicely organized visual guide identifying the available resources to innovators, all of which are accessible via active hyperlinks. Given that guidance documents and other resources have been removed from FDA’s website without warning (sometimes reinstated and sometimes not), we suggest you download any useful resources now.

While much of the Navigator organizes already existing information into an easy to find format, there was one new piece of information that caught our attention:  the introduction of Early Orientation Meetings. FDA recommends these interactions shortly after a submission has been accepted for review. The meetings are best for novel devices as they are intended to allow sponsors of marketing submissions to provide device demonstrations and/or an overview of the submission. Explanations, especially in the context of digital health products, have increasingly grown more important to demonstrate how the product will work in the intended use environment, and how, if it all, it will affect existing clinical workflows. Demonstration of software products can be a far more effective way to showcase novel features or functions as compared to still screenshots of the user interface that are included in a submission. Explaining early on how the technology works (e.g., how the device functions or achieves its intended use via inputs and outputs) to FDA reduces any gaps in knowledge that may hamper submission review,  and allows FDA to ask questions and receive clarification on any initial sticking points.

Early orientation meetings are appropriate for any traditional 510(k)s, De Novo requests, and PMAs. A sponsor can request an early orientation meeting in the cover letter of their marketing submission. However, as our recent blog post highlighted, sponsors are already experiencing delays scheduling meetings within the paradigm of existing initiatives. It is therefore unclear how FDA will be able to accommodate potentially additional requests for meetings. As FDA states on the website about early orientation meetings, it “will try to accommodate meeting requests, resources permitting.” Sponsors may want to consider their resources and return on value on these interactions if “[t]he FDA review team does not generally provide specific feedback on the submission during the meetings.” As we have opportunities to engage in these meetings in the future, we will report back on what we are seeing, and the extent to which having, or not having an early interaction meeting, has any impact on the ultimate submission review.