Objectives of FDA’s Guidance for Mobile Medical Applications
Bakul Patel, Associate Director for Digital Health at CDRH, explains the FDA’s objectives in creating its new mobile health guidance.
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Which Mobile Medical Apps Are Regulated?
Bakul Patel, Associate Director for Digital Health at CDRH, clarifies what mobile health devices are regulated by FDA and which fall into enforcement discretion.
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Determining If a Mobile Medical App Is Regulated
Bakul Patel, Associate Director for Digital Health at CDRH, shares his perspective on interpreting the FDA’s mobile health guidance.