The U.S. FDA has named the companies selected to participate in a first-of-its kind pilot program that will help revolutionize digital health regulation in the United States. FDA Commissioner Scott Gottlieb, MD, announced the nine participants, who include leaders and innovators in the medical device and technology sectors, of the FDA’s digital health software pre-certification pilot program (FDA Pre-cert) during his keynote address on September 26 at the AdvaMed MedTech Conference in San Jose.
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. The goal of this new approach is for the FDA to, after reviewing systems for software design, validation and maintenance, determine whether the company meets quality standards and if so, to pre-certify the company.
With the information gleaned through the pilot program, the agency hopes to determine the key metrics and performance indicators for pre-certification 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 is also considering, as part of the pilot program, whether and how, pre-certified companies may not have to submit a product for premarket review in some cases.
“Our method for regulating digital health products must recognize the unique and iterative characteristics of these products,” says Gottlieb. “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.”
The FDA launched the Pre-cert pilot program on July 27, 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 Pre-cert pilot program.
The pilot participants represent a wide range of companies and technology in the digital health sector, including small startups and large companies, high- and low-risk medical device software products, medical product manufacturers, and software developers. Participants selected include:
- Apple: Cupertino, Calif.
- Fitbit: San Francisco
- Johnson & Johnson, New Brunswick, N.J.
- Pear Therapeutics: Boston
- Phosphorus: New York
- Roche: Basel, Switzerland
- Samsung: Seoul, South Korea
- Tidepool:Palo Alto, Calif.
- Verily: Mountain View, Calif.
The FDA received interest in the program from more than 100 companies. In selecting the participants, the agency 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’s selection process identified companies that represent different perspectives and unique approaches to digital health technology development.