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The misnamed Medical Device Safety Act of 2009 would gut the carefully crafted regulation of medical devices by the Food and Drug Administration, exposing developers to the conflicting laws and regulations of 50 different states and subjecting them to abusive and punitive tort litigation.
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.
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.