SILVER SPRING, Md. – The U.S. Food and Drug Administration has announced the names of the companies selected to participate in its Pre-cert pilot program aimed at streamlining the agency’s approach toward digital health technology.
The pilot participants include Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsun, Tidepool, and Verily.
“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,” said Dr. Scott Gottlieb, FDA Commissioner, in a statement.
The goal of the Pre-cert program 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 it.
With the information gleaned through the pilot, 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 pre-market review in some cases.
“Our method for regulating digital health products must recognize the unique and iterative characteristics of these products,” said 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.”
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.
“We are extremely appreciative of the tremendous interest in participating in the FDA Pre-cert pilot program,” said Bakul Patel, associate director for digital health in the FDA’s Center for Devices and Radiological Health, in a statement. “The number of applicants speaks to the significant impact this approach could have on facilitating timely advancement of software that has the potential to benefit health.”
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.
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.