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.
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.
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.