Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, authored an article in The Journal of mHealth titled “Walking a Fine Regulatory Line: Selling General Purpose IT Equipment for Specific mHealth Applications.”
Following is an excerpt:
Tech companies have noticed the mhealth market. They have products like smart phones, routers, and other communications equipment that have uses in many different industries, including healthcare. They want to enter the healthcare market but they wish to avoid regulation by the U.S. Food & Drug Administration (“FDA”).
Unfortunately, many of those companies struggle to understand the definition of a regulated “medical device” and the degree to which they can promote their products for medical use without crossing the line into FDA territory. Many, for example, want to know whether, in their promotional materials, they can discuss medical uses without having to comply with U.S. medical device requirements. The answer is yes, but they need to walk a fine line.
