FDA is asking questions about how to overhaul digital health product regulation and relying on expertise within the industry to do so, according to Bakul Patel, FDA’s associate center director for digital health, who recently spoke with MDO.

In late 2017, FDA launched the Digital Health Innovation Action Plan. Within that plan is a recipe to shake up the traditional way FDA handles submissions, reviews, and post-market data – at least for digital products.

The plan lays out three courses of action.

• Under the 21st Century Cures Act, FDA will provide qualification and clarification of the policies for medical software.
• Second is building the right skillsets to prepare FDA for a digital health future. Patel said the entrepreneurs-in-residence program will allow FDA to add expertise in software design, process modeling, and evidence gathering, among other skills.
• Third is a drive to instill trust in digital technologies by providing regulatory oversight that will enable patients to get the products first in the world.

FDA is considering how to align with how products are being made, how the agency responds to market timelines, and how the products fit in a global market. “We need to make sure that digital health products really know no borders and can be converged with the principles that we have agreed upon with the international regulators,” Patel said.

FDA’s plan is to move from a “product-by-product base towards a company base, to start relying on a company’s culture of quality and organizational excellence” and leverage that credit to streamline FDA’s process. Patel said the key is that FDA is not looking to review digital products in a traditional sense, but instead aiming to streamline in an appropriate manner for the technology.

Such a system could look like this, said Patel: A digital marketing company goes through a pre-certification program, which requires a comprehensive look at the systems and design. Once they complete that certification program successfully, low-risk digital products might go straight to market without review. In exchange, they would commit to collect post-market and real-world evidence data to substantiate further iterations of the product.

Patel was quick to note this scenario may not fit every product or every digital company, but it is an example of what FDA might deem “appropriate” and noted that it is a new paradigm for FDA. Over the next several months, FDA will be exploring the possibilities of this paradigm shift (as well as its limitations) with nine companies enrolled in the pilot precertification program.

FDA will be working with those companies, starting with how to set the yardstick for a “culture of quality and organizational excellence.” Patel said the process will be highly methodical, but right now, they are asking questions. Then the agency will turn attention to deciding what the streamline path will look like for review. Patel noted that FDA is not only thinking about submissions but also focusing on how the organization will conceptualize such reviews. Once those are finished, the group will explore the expectations for post-market management.