Lexology October 18, 2021
Primary Regulatory Regimes Relevant to mHealth
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.
The first two articles in our series examine important HIPAA provisions (see Part I and Part II) .
Federal Food, Drug and Cosmetic Act (FDCA)
What is FDCA?
FDCA regulates the safety and effectiveness of medical devices, including certain mobile medical apps.
A “device” or medical device means “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is … intended for use in the diagnosis of disease or other conditions,...
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