April 26, 2018

Media Inquiries

  Stephanie Caccomo
  301-348-1956

"We know that consumers and health care providers are increasingly embracing digital health technologies to inform everyday decisions. Given the benefits from empowering consumers, we believe the FDA must encourage the development of tools that can help people be more informed about their health,” said FDA Commissioner Scott Gottlieb, M.D. “Our approach to regulating these novel, swiftly evolving products must foster innovation and maintain our gold standard for safety and effectiveness. In that spirit, today we’re announcing two important new components of our Digital Health Innovation Action Plan. First, we’re releasing a working model for our Digital Health Software Precertification Pilot Program that provides our vision for the pilot while asking for specific input from our stakeholders to allow us to continue improve this innovative program. Second, we’re issuing draft guidance to provide transparency and clarity to the digital health community about how the FDA intends to review devices with multiple functions; where one of those purposes is an FDA-regulated function, while a second attribute performs a function that the FDA does not regulate as a medical device. An efficient approach allows the agency to focus on those functions that the FDA oversees, while allowing the industry to modernize digital tools in ways that can deliver additional benefits."

The FDA recognizes that it can help encourage digital health innovation by making its policies and processes more efficient and modernizing its regulatory tools. As part of the FDA’s Digital Health Innovation Action Plan issued in 2017, the agency committed to developing a new regulatory framework for reviewing software as a medical device and issuing a suite of guidances to provide transparency and clarity to product developers about the agency’s regulatory process.

Today, the agency published an important progress update on the software precertification pilot program, the FDA’s proposed voluntary pathway for pre-certifying companies to enable a more streamlined review of their software as a medical device. The FDA is releasing a working model for its vision of the pilot, which outlines the most critical components of the pilot, like the precertification of companies, the premarket review process and postmarket surveillance. The agency is asking for public comment on the working model in order to obtain the critical feedback necessary to continue developing the program.

In addition to the pilot progress update, the FDA is releasing a draft guidance that addresses an important provision of the 21st Century Cures Act. The draft guidance offers additional clarity about where the FDA sees its role in digital health, and importantly, where the agency will not be involved.

Medical products may contain several functions, some of which are subject to the FDA’s regulatory oversight as medical devices, while others, in isolation, are not. This draft guidance, “Multiple Function Device Products: Policy and Considerations,” explains the FDA’s proposed regulatory approach and policy for all multiple function device products. This guidance clarifies when and how the agency intends to look at the impact of non-regulated functions on the safety and effectiveness of device functions that are subject to FDA review. For example, consider a hospital monitor that detects and transmits vital patient signal information like heart rhythms into a patient’s electronic health record. In this case, the FDA would only review the heart monitor function, unless the transmission function impacts the safety or effectiveness of the monitor function or adversely affects the monitor capability. In that case, the developer only needs to show that they’ve addressed any potential for an adverse impact between the two different functions – the one the FDA oversees, and the one it does not. This example and others provided in the guidance demonstrate that by providing greater transparency and clarity on how the agency intends to approach these multiple function products, the FDA hopes to further encourage innovation in this important field.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.