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Federal Food Drug and Cosmetic Act (FFDCA) mHealth

K&L Gates LLP

US Regulatory Considerations Applicable to Digital Health Providers and Suppliers - Part III: FDCA

K&L Gates LLP on

This article examines another major regulatory regime relevant to mHealth application developers – the Federal Food, Drug and Cosmetic Act (FDCA), as well as regulatory issues unique to non-US companies. ...more

Sheppard Mullin Richter & Hampton LLP

New York AG Takes Enforcement Action Against Heart Monitoring Apps: Murmurs of Concern are Heard in mHealth App World

In a move sure to cause murmurs in the large and growing mobile health application industry, the Office of New York Attorney General Eric Schneiderman (OAG) has used state trade laws to extract concessions and monetary...more

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