FDA chief outlines digital health strategy for post-market medical device regulation
Food and Drug Administration Commissioner Scott Gottlieb, MD, mapped out the agency’s Digital Health Innovation Plan on Thursday, which will provide post-market guidance to how the FDA intends to regulate digital medical devices.
Gottlieb zeroed in on health-related apps, which he stressed the importance of the FDA to instate supporting policies and regulatory tools to “encourage safe and effective innovation.”
“In this rapidly changing environment, ambiguity regarding how FDA will approach a new technology can lead innovators to invest their time and resources in other ventures,” Gottlieb wrote in a blog post.
The FDA will be creating a risk-based regulatory framework for overseeing these medical technologies that will be launched in the fall. The agency is determining how to create a third-party certification program under which lower risk digital health products can be marketed without FDA premarket review.
Gottlieb said the agency is also looking into streamlining the FDA premarket review of higher risk products.
“Employing a unique pre-certification program for software as a medical device could reduce the time and cost of market entry for digital health technologies,” Gottlieb wrote.
The agency will be crafting clear policies to help developers create safer products. Gottlieb said the FDA is working on implement elements of the 21st Century Cures Act that will clarify which digital health aspects are regulated by the FDA and explain how these new provisions affect current FDA policies.
Gottlieb said the agency will be providing guidance for products with multiple software functions and those products with “low enough risks that the FDA does not intend to subject them to certain pre-market regulatory requirements.”
“Greater certainty regarding what types of digital health technology is subject to regulation and regarding FDA’s compliance policies will not only help foster innovation, but also will help the agency to devote more resources to higher-risk priorities,” Gottlieb added. “Applying this firm-based approach, rather than the traditional product-based approach, combined with leveraging real-world evidence, would create market incentives for greater investment in and growth of the digital health technology industry.”