Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in the Bloomberg BNA article “FDA Guidance Describes Plans to Exempt Multiple Types of Devices from 510(k),” by Michael Williamson.
Following is an excerpt:
At that time, Bradley Merrill Thompson, an attorney with Epstein Becker & Green PC, told Bloomberg BNA the draft guidance may positively affect the mobile health (mHealth) industry and the development of health-related smartphone applications (apps). Many of the device classifications specified for 510(k) exemption in the guidance, such as thermometers, stethoscopes, talking first aid kits, fertility diagnostic devices and exercise equipment, fall under the mHealth category, he said.