FDA Commissioner Scott Gottlieb, MD, on Feb. 13 laid out plans for a Center of Excellence on Digital Health as part of the agency's request for 2019 funding.
President Donald Trump released his $4.4 trillion budget for fiscal year 2019 on Feb. 12, including roughly $400 million in additional funding for the FDA. In his statement, Dr. Gottlieb outlined several initiatives the agency intends to launch with resources proposed under President Trump's budget.
"The Administration's newly released budget request provides the FDA with the resources to continue to fund our current programs at consistent levels," Dr. Gottlieb said. "The request will allow the agency to continue to support our core public health mission."
The Center of Excellence on Digital Health would establish a new regulatory pathway for digital health technologies. The proposed pathway, which launched its pilot phase in July, aims to streamline the approval process by reviewing developers, rather than individual products. Pre-certified developers would collect post-market data on their products, which the FDA would then use to confirm product safety.
The Center of Excellence on Digital Health would also work to evaluate third-party certifiers and support a cybersecurity unit focused on medical devices.