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FDA Considers New FDASIA Workgroup Recommendations for Regulating Health IT

16 September 2013

Medical Device Alert

On Wednesday, 4 September 2013, a working group tasked with making recommendations for optimal regulation of health information technology (HIT) delivered its final report to the FDA, the ONC, and the FCC. The final report recommends only very low level regulation for low-risk HIT products and requests that the FDA expedite the final guidance on medical mobile applications for smartphones and other mobile devices (medical mobile apps).

Read More: FDA Considers New FDASIA Workgroup Recommendations for Regulating Health IT

The team

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