FDA recently published Guidance on how it intends to regulate Mobile Medical Devices and Medical Apps moving forward. An understanding of this Guidance and the regulatory evolution up to the publication of the rule is essential for any company considering the use and promotion of a proprietary App. Failure to understand the Guidance and FDA's stated position could put a company at risk for Agency enforcement action. Confirming this risk is the fact that FDA and the Federal Trade Commission ("FTC”) have both already taken enforcement action against unapproved and misleading products and Apps in the market.
Live webinar on regulation of Mobile Medical Devices and Medical Apps
12 March 2014, Houston, Texas,, United States
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Online, 10777 Westheimer Suite 1100, Houston, Texas,, 77042, United States
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Compliance2go
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