In a recent article, HealthcareITnews reviews the important steps taken by the FDA last year toward regulating decision support, software-as-a-medical-device, mobile tech in clinical trials and more.
Beyond fielding an ever-increasing number of digital health clearances, the FDA had a full plate in 2017 as it sought to revise its regulatory processes for the shifting healthcare landscape. The beginning of the year saw a new administration take the reins, and with it the nomination and appointment of a new commissioner, Scott Gottlieb.
By year's end, the new guard already had announced and implemented a firm-focused pre-certification program, released new guidances addressing provisions of 2016's 21st Century Cures Act, and outlined a handful of other ongoing initiatives that are sure to impact the digital health industry. The article describes a rundown of the agency's actions and announcements during 2017....
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