FDA Seeks to Revolutionize Digital Health Approvals

Scott Gottlieb, M.D., the new FDA Commissioner, wants to revolutionize digital health regulations. On September 26, 2017, he named nine tech companies that will participate in the agency’s digital health software precertification (FDA PreCert) pilot program.

The medical device regulators at the FDA are well experienced at pushing hardware through the regulatory approval process. Software and digital devices? Not so much.

Software as Medical Device

The term “Software as a Medical Device” (SaMD) is defined by the agency as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”

For example, some digital devices transfer patient data from the device to another source, allow for device control and programming, and monitoring patients remotely. As this technology continues to evolve, it is increasingly incorporated in the design of medical devices.

FDA PreCert Program

The FDA PreCert program is designed to look at the software developer, rather than primarily the product. The agency will review systems for software design, validation and maintenance, determine whether the company meets quality standards and if so, to precertify the company.

With the information gathered from the pilot program, the agency hopes to determine the key metrics and performance indicators for precertification and identify ways that precertified companies could potentially submit less information to the FDA than is currently required before marketing a new digital health tool as part of a formal program. The FDA is also considering, as part of the pilot program, whether and how, precertified companies may not have to submit a product for premarket review in some cases.

The PreCert pilot program was launched on July 27, 2017 as part of the agency’s Digital Health Innovation Action Plan. The plan outlines the agency’s vision for fostering digital health innovation while continuing to protect and promote public health by providing clarity on medical software provisions of federal legislation passed in 2016 (21st Century Cures), adding expertise to the digital health unit and initiating the FDA PreCert pilot program.

Participants selected include:

• Apple, Cupertino, California
• Fitbit, San Francisco, California
• Johnson & Johnson, New Brunswick, New Jersey
• Pear Therapeutics, Boston, Massachusetts
• Phosphorus, New York, New York
• Roche, Basel, Switzerland
• Samsung, Seoul, South Korea
• Tidepool, Palo Alto, California
• Verily, Mountain View, California

Apple is studying whether its watch can detect heart abnormalities. The process it will go through to make sure it’s using sound quality metrics and other measures won’t be as costly and time-consuming as when the government clears a new pacemaker, for example. Verily, the life sciences arm of Google parent Alphabet Inc., is working with Novartis AG to develop a contact lens that could continuously monitor the body’s blood sugar.

Building Expertise

As part of the PreCert pilot program, participants have agreed to provide access to measures they currently use to develop, test and maintain their software products, including ways they collect post-market data. Participants also agreed to be available for site visits from FDA staff, and provide information about their quality management system. This sharing will help the FDA continue to build its expertise in these areas, while giving the agency the information it needs to provide proper oversight of these products and firms.

The FDA plans to share public updates about the PreCert pilot program via the pilot program webpage as well as through stakeholder meetings, including a January 2018 workshop.

To read the details from the FDA, click here.