Today, the U.S. Food and Drug Administration (FDA) announced it has selected Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool and Google’s Verily to participate in the FDA’s new digital health per-certification pilot program. The FDA selected the final nine companies for the pre-cert pilot program based on several factors including company size, demonstrated record of quality and organizational excellence, clinical focus area and the risk profile of the product. More than 100 companies submitted entries to join the pilot program.
FDA Pre-cert Digital Health Pilot Program Overview
The FDA launched the Pre-cert pilot program on July 27, as part of the agency’s Digital Health Innovation Action Plan to foster 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). The pilot program will focus on looking at the software developer or digital health developer first, instead of traditionally looking primarily at the product.
After reviewing the systems for software design, validation and maintenance, the FDA will determine whether the company meets quality standards and if so, to precertify the company. With the information gathered through 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.
As part of the pre-cert digital health pilot program, all nine selected companies are required to:
– Provide access to measures for developing, testing and maintaining software products and demonstrating a culture of quality and organizational excellence measures by KPI
– Collect real-world post-market data and provide it to FDA
– Meet with FDA for real-time consultation
– Be available for site visits from FDA officials
– Provide information about the firm’s quality management system
“Our method for regulating digital health products must recognize the unique and iterative characteristics of these products,” said FDA Commissioner Dr. Scott Gottlieb 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.”
FDA will hold a public workshop in January 2018 to report on and review their initial findings, as well as provide pubic updates via the pilot program webpage as well as through stakeholder meetings. Throughout the pilot, the FDA will solicit feedback from the selected participants, as well as from industry, stakeholder groups and the public.
