WASHINGTON – The U.S. Food and Drug Administration’s Center for Devices and Radiological Health recently announced it was expanding its medical software precertification program and establishing an incubator for digital health technology.
Experts are applauding the agency’s efforts to continue advancing innovation in health care.
“The government’s commitment is clear,” said Linda Pissott Reig, a shareholder at Buchanan Ingersoll and Rooney, a law firm whose clients include home care and hospice services, post-acute care facilities and medical device companies. “The FDA has undertaken many new initiatives that signal a proactive and thoughtful approach to spurring new medical devices and medical technologies.”
The FDA said it is expanding its precertification pilot program, drafted last year to enable a more streamlined review of their software as a medical device, to include: tools that have multiple functions; artificial intelligence-based tools; and digital therapeutic tools.
Nine companies were selected last year to take part in the pilot: Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool and Verily. The FDA hopes to add more companies and formally launch the expanded pilot by the end of the year.
“This regulatory attempt has the goal of moving the set point in the continuum of no regulation and extreme control toward a rational compromise between risk and cost and the speed of market availability,” said Dr. Joseph Roberson, chief medical officer of digital health platform provider VitalConnect. “A large number of differing medical technologies have brought about entirely new categories of devices and opportunities for device failure that has greatly complicated the FDA’s mission in recent years. I expect that trend will continue to accelerate.”
The agency also launched the Information Exchange and Data Transformation (INFORMED) incubator that will explore the use of real world data, biosensors, artificial intelligence and the Internet of Things to improve cancer treatment and drug development.