Bradley Thompson, a Member of the Firm in the Health Care and Life Sciences practice in the Washington, D.C., office, was quoted in an article about FDA’s regulation regarding mobile medical devices.
The article discussed how Medtronic and St. Jude Medical recently unveiled products that use cell phone technology to monitor implantable cardiac devices. So far, there is no guidance in this area, so the FDA is regulating such products on a case-by-case basis. The article went on to mention that the lack of a clear regulatory path for such devices can create issues because the products tend to be considered accessories to existing classified devices.
Although smart phones are being used in conjunction with medical devices, the FDA usually does not regulate them as devices. If a phone is bought off the shelf and there are no medical claims for the phone, then the maker of the phone does not have to comply with FDA requirements, said Thompson.