Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "iPads, iPhones, Androids, and Smartphones: FDA Regulation of Mobile Phone Applications as Medical Devices."
Following is an excerpt:
Bradley Merrill Thompson explains that "[i]n the area of mobile health technology, it's important to understand that an accessory or a component of a medical device is itself a regulated medical device." ...
Thompson puts it simply. "End-users buy accessories, while manufacturers buy components."...
Thompson explains that "[c]omponents are exempt from most FDA regulatory requirements, with the regulatory burdens being borne by the finished device manufacturer."
"Accessories, on the other hand, since they go right to the end user, must meet the FDA requirements before they leave the hands of the accessory manufacturer."
