Technology companies Apple, Fitbit, Samsung and Verily were among nine companies that the U.S. Food and Drug Administration (FDA) selected for a pilot program that will test a new digital health software pre certification process (FDA Pre-cert).
The FDA’s Pre-cert pilot program is intended to inform a tailored approach toward digital health technology by looking at the software developer or digital health technology developer, rather than primarily at the product, according to a FDA press release. “The goal of this new approach is for the FDA to, after reviewing the systems for software design, validation and maintenance, determine whether the company meets quality standards and, if so, to pre-certify the company,” the FDA stated.
With information gained from the pilot program, the FDA hopes to determine the key metrics and performance indicators for recertification and identify ways that pre certified 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 stated. “The FDA is also considering, as part of the pilot program, whether and how, pre certified companies may not have to submit a product for remarked review in some case,” the FDA stated in the press release.
While there are some big names in the technology world on the list of the pilot participants—Apple, Fitbit, Samsung—there are also some small startups as well. The participants in the pilot are: Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool and Verily. Pear Therapeutics is a startup that developed a mobile app designed to help treat substance use disorder, and the app was recently approved by the FDA. Tidepool developed an open source platform for diabetes data.
“Our method for regulating digital health products must recognize the unique and iterative characteristics of these products,” FDA Commissioner Scott Gottlieb, M.D., said in a statement.. “We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate, and helps foster beneficial technology while ensuring that consumers have access to high-quality, safe and effective digital health devices. These pilot participants will help the agency shape a better and more agile approach toward digital health technology that focuses on the software developer rather than an individual product.”
In accounting the participating companies, the FDA noted that the participants represent a wide range of companies and technology in the digital health sector, including high- and low-risk medical device software products, medical product manufacturers and software developers. The FDA says more than 100 companies expressed interest in the pilot program. In selecting the participants, the FDA says it considered several factors, including company size, demonstrated record of quality and organizational excellence, clinical focus area and the risk profile of the product.
The FDA launched the Pre-cert pilot program back in July as part of the agency’s Digital Health Innovation Action Plan, which outlines the agency’s vision for fostering digital health innovative while continuing to protect and promote public health by providing clarity on medical software provisions of federal legislation passed in 2016 (21st Century Cures Act).
As part of the Pre-cert 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 Pre-cert pilot program via the pilot program webpage as well as through stakeholder meetings, including a January 2018 workshop. Throughout the pilot, the FDA will solicit feedback from the selected participants, as well as from industry, stakeholder groups and the public.
