FDA kicks off the next phase of digital health plan

 In Medical Product Design

On July 27, 2017, U.S. Food and Drug Administration commissioner Scott Gottlieb announced the next steps in the agency's plans for a digital health initiative. In June, the commissioner stated the FDA would establish new guidelines for connected medical devices and a pilot program for its new approach to pre-certification for health apps. The agency has now followed up by providing more details and opening applications for the pilot program.

These fast-moving events are highly relevant to the makers of innovative medical products. Digital health apps and connected devices are likely to have an increasingly meaningful role to play in diagnosis, treatment and prevention over the years to come. Shifting regulations, including opportunities to move apps and other products to market more quickly, could open up exciting possibilities for medical device firms.

Action on digital health from the FDA

"The FDA presented a vision for moving beyond its traditional handling of medical devices."

The FDA's Center for Devices and Radiological Health laid out its plans to encourage fresh developments in connected tools for healthcare in the Digital Health Innovation Action Plan released along with Gottlieb's announcement. The document presents a vision for how the agency will move beyond its traditional handling of medical devices to account for the unique considerations that go along with digital health technology.

The CDRH's goals begin with offering greater clarity to developers of medical software about how they are impacted by provisions in the 21st Century Cures Act, which went into effect in December 2016. The law excluded low-risk software like health and wellness apps
or administrative computer programs from being regulated as medical devices. New guidance will explain how this change in policy is to be implemented. The provisions include specific attention to issues like setting the conditions for when a change in software calls for a new premarket submission, and how to evaluate products that have multiple functions, only some of which fall under FDA jurisdiction.

Additionally, the CDRH intends to bring in new staff to keep up with the latest advancements in digital health technology. These specialists will be tasked with improving the quality and speed of the agency's decision-making about such products. An Entrepreneurs in Residence program will further build the FDA's awareness of new advances in technology that could have important implications for regulators.

Changes to regulations could bring medical software to market faster.Changes to regulations could bring medical software to market faster.

What's ahead for digital health pre-certification

For makers of new medical products, the details about the pre-certification program were the  most significant part of Gottlieb's announcement. Under this new initiative, the FDA will streamline clearance for digital health tools by considering the developer's reliability in testing the safety and effectiveness of all its products. Companies that have met high standards for quality in designing, validating and maintaining digital health software will be required to provide less information in premarket submissions, or in some cases not undergo premarket submission at all.

Before putting this policy into full effect, the FDA is running a pilot program that is planned to include up to nine software firms. For a company to participate, it must be currently developing or planning a software product that fulfills the agency's definition of a "medical device." The firm should be able to demonstrate that it has successfully brought such products to market in the past and meets key performance indicators for organizational excellence.

During the program, the businesses involved will have to allow the FDA a high level of visibility. This includes offering access to internal measures for the company's operations and its approach to developing, testing and maintaining software. The organization will also pass along post-market data and information about its quality management system, as well as taking part in site visits, meetings and consultations with the FDA.

In his announcement, Gottlieb explained that the new way of handling digital health is a necessary update to a regulatory system that was not built with today's rapidly advancing software in mind.

"We need to make sure our approach to innovative products with continual updates and upgrades is efficient and that it fosters, not impedes, innovation," he wrote. "Recognizing this, and understanding that the potential of digital health is nothing short of revolutionary, we must work toward establishing an appropriate approach that's closely tailored to this new category of products."

The agency is accepting applications from firms interested in participating in the pilot program as of August 1. Bradley Merrill Thompson, an attorney with the firm Epstein Becker Green who is experienced in guiding digital health companies through interactions with regulators, expressed optimism about the strategy in an email to Healthcare IT News.

"This stuff is really hard to figure out in the abstract, and it's really only by working with companies and tinkering and experimenting that we can truly identify the best model," Thompson said.

The FDA is transforming how it handles digital health software in ways that could have major implications for medical device makers. This shift, including the start of a pre-certification pilot program, will present fresh opportunities for going to market with connected devices that offer innovative features and distinctive visual brand language. For businesses that are interested in getting a head start on being involved in the revised clearance process, the pilot program is an exciting chance to leap forward into the next stage of regulation.


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