Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was mentioned in Telehealth & Telecare Aware, in “Avoiding the FDA Health IT-Medical Device Regulatory Trap for General IT Companies,” by Donna Cusano.
Following is an excerpt:
The always-informative Bradley Merrill Thompson of the Epstein Becker Green law firm delineates the fine regulatory line that general purpose IT companies must observe when working with healthcare customers. First there is intended use, based on how the manufacturer intends its customer to use the product; if the customer uses it for the diagnosis or treatment of disease or other conditions, FDA will regulate it as a medical device. This is less clear than it seems, and Mr. Thompson explores where a general IT company can, in the old PR adage, ‘say it safely’ and avoid falling into the unwanted medical device trap by avoiding medical feature and advice claims, and keeping the context away from medical use.
Ms. Cusano’s article reviews “Walking a Fine Regulatory Line: Selling General Purpose IT Equipment for Specific mHealth Applications,” a piece Mr. Thompson wrote for the August 2015 issue of The Journal of mHealth.
