September 29, 2017
Authored and Edited by Scott A. Allen; Kathleen A. Daley
In July 2017, as part of its larger Digital Health Innovation Action Plan, FDA announced the launch of a software precertification pilot program. The program is aimed at finding a more efficient, risk-based approach to regulating digital health technology that will help foster innovation in the digital health space. The program resulted, in part, from FDA's recognition that the traditional approaches for premarket approval for moderate and higher risk hardware-based medical devices is not well suited for the faster design, development, and validation processes used for software products. Through the pilot program, FDA intends to develop a premarket paradigm that accommodates the faster rate of development and innovation of software devices where traditional premarket requirements might otherwise impede or delay patient access to digital health software technology.
FDA explained that the companies participating in the pilot program will explore the use of external software development standards to reduce premarket software documentation burdens. Depending on the results of the program, the precertification process could allow companies that demonstrate a culture of quality and organizational excellence to bring certain types of digital health products to market without FDA premarket review or after a less burdensome and more streamlined FDA premarket review. FDA announced that the criteria developed for precertification during the pilot program may also be used to establish a third-party certification program, in which third parties may facilitate the precertification of companies developing digital health products.
In September 2017, FDA Commissioner Scott Gottlieb announced that FDA received interest in the pilot program from more than 100 companies and that nine participants were selected. The nine participants companies are from different sectors of the digital health space: Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool, and Verily. FDA plans to share public updates on the pilot program webpage, as well as through stakeholder meetings, including a workshop planned for January 2018.
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