In response to the rapid pace of innovation in the health and life sciences arena, the US Food and Drug Administration (FDA) is taking a proactive, risk-based approach to regulating digital health products. Software applications and other transformative technologies, such as artificial intelligence and 3D printing, are reshaping how medical devices are developed, and FDA is seeking to align its mission and regulatory obligations with those changes.
FDA’s digital health software precertification program is a prime example of this approach. Once fully implemented, this voluntary program should expedite the path to market for software as a medical device (SaMD), and promote greater transparency between FDA and regulated entities.
Under the program, FDA will conduct a holistic review of the company producing the SaMD, taking into account aspects such as management culture, quality systems and cybersecurity protocols, to ascertain whether the company has developed sufficient infrastructure to ensure that its products will comply with FDA requirements and function safely as intended. Companies that fulfill the requirements of the excellence appraisal and related reviews will receive precertification that may provide for faster premarket reviews and more flexible approaches to data submissions at the outset.
However, companies that secure the precertification may have increased post-market surveillance and data collection obligations, with a particular emphasis on real-world data. Increased post-market reporting obligations for SaMD in the precertification program may allow the FDA to encourage innovation and faster premarket review cycles while still conducting a thorough assessment of a product’s safety and efficacy when used by a broader patient population. Companies and investors should make sure that their medical device and SaMD development strategies take into account the evolving FDA regulatory regimes for digital health and the possibility of greater post-market study and surveillance obligations.
The program is currently in the pilot phase, and FDA is seeking test cases as a part of its 2019 Test Plan Interested companies that plan to submit, in the next year, a de novo request or 510(k) submission for software as a medical device may send a statement of interest to FDAPre-CertPilot@fda.hhs.gov.