WASHINGTON – The U.S. Food and Drug Administration recently unveiled a pre-certification pilot program for digital health technology, and industry leaders are optimistic the program will speed up the process of getting new innovations safely into the hands of consumers and providers.
“Under the FDA’s new program, American innovators will have greater flexibility to create the health and wellness tech solutions that are already monitoring personal health and helping doctors treat patients more efficiently,” said Julie Kearney, vice president of regulatory affairs for the Consumer Technology Association.
As part of the agency’s Medical Innovation Access Plan announced in July, the Pre-Cert for Software Pilot 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, said Dr. Scott Gottlieb, comissioner of the FDA, in a recent blog post announcing the pilot.
The FDA’s new approach allows the federal government to keep up with the industry’s fast pace of innovation, while preserving consumer safety, industry leaders say.
“The FDA’s traditional approach to medical devices is not well suited to these products,” said Gottlieb. “We need a regulatory framework that accommodates the distinctive nature of digital health technology.”
The Advanced Medical Technology Association is optimistic about the pilot, said Janet Trunzo, senior executive vice president, technology and regulatory affairs.
“If properly implemented, the program has the potential to reduce pre- and post-market burdens for both software developers and FDA,” she said.
Applications for the pilot are currently being accepted and the FDA will choose nine companies to participate, ranging from small startups to large companies that develop both high- and low-risk devices. The agency will report on its findings next January.