According to Bradley Merrill Thompson, Partner, Epstein Becker & Green, P.C., that FDA might regulate certain equipment like cell phones that companies are planning to put at the center of connected health services.
In his article, he outlines the factors that FDA considers when deciding whether to regulate such equipment.
The Section 201(h) of the Federal Food, Drug, and Cosmetic Act defines a medical device as:
“… an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is … [either]
intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals … [or]
intended to affect the structure or any function of the body of man or other animals.”
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Tags: fda, mobile phone, regulation