BOSTON – Bakul Patel said his agency could become known as the ‘U.S. Food, Device and Drug Administration’ in the future as the digitization of health care continues to evolve.
“Digitization is happening all around us—especially in health care,” said Patel, associate director for digital health, U.S. Food and Drug Administration, to attendees of the Biomarkers & Immuno-Oncology World Congress this week. “We are seeing health care move from the clinic to the patient.”
That shift is driving the work of the FDA, as the agency moves to a more pragmatic approach and focuses on higher-risk functionality of medical devices, assuring patient safety while encouraging advances in innovative technology and product life cycle, he said. Focus areas include software, sensors, technology and connectivity.
The rapidly evolving nature of digital health is sparking a paradigm shift, Patel said. The current regulatory premarket timeline is best suited for hardware-based products, but is making way for software development timelines, practices and rapid iterations.
Deterministic risks are shifting to evolving issues like cybersecurity, and a stable program volume of about 2,200 pre-submissions annually to the agency is expanding to the potential for an exponential increase in the volume of submissions.
These changes led the FDA to develop its Pre-Cert for Software as a Medical Device Pilot, which will review a digital health technology company’s systems for software design, validation and maintenance, and if it meets the necessary quality standards, pre-certify it. Pre-certified companies may be able to submit less information to the FDA than is currently required before marketing a new digital health tool.
“We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate,” Patel said. “This program 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.”