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Digital Health: Significant FDA Policy Developments In 2022 - Healthcare
In 2022, FDA retreated from a flexible approach to its regulation of digital health in two key areas: (1) its PreCertification Program for software as a medical device (SaMD) and (2) its guidance.
Scott gottlieb
Software precertification program
Precertification program
International medical device regulators forum
Precert program
Health it report proposed strategy
Software precertification pre
Framework for conducting the pilot program
International medical device
Drug administration staff
Clinical decision support software
Enforcement discretion
Drug administration
Cert program
Clinical decision support software guidance
Patient decision support software
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