— Graphic by Paul Sonnier
The Food and Drug Administration is redefining how it regulates digital health products.
The agency’s new commissioner, Scott Gottlieb, M.D., says its new Digital Health Innovation Plan will “include a novel, post-market approach” to digital devices and that the FDA will present new guidance for digital health product design to provide more clarity for manufacturers.
Dr. Gottlieb asserts that that program will help eliminate regulatory ambiguity while promoting innovation and free regulators to focus on more pressing healthcare matters.
Digital health industry leaders were happy about Dr. Gottlieb’s remarks.
“All in all, I feel like I’ve died and gone to heaven,” Bradley Merrill Thompson, a medical-device lawyer with Epstein Becker Green and the Clinical Decision Support Coalition’s general counsel, told FierceHealthcare.
Health IT Now Executive Director Joel White said he is “deeply encouraged” by the Dr. Gottlieb’s approach, adding that regulations need to keep pace the “rapid development cycles of health IT.”
“This is all about a modern FDA that better serves the needs of patients,” he said.
Dr. Gottlieb likes a “third party certification program” in which lower-risk devices could be marketed without FDA approval, while approval of higher- risk devices could be streamlined and speeded based on a company’s history.
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