As Reston-based AFrame Digital looked to bring its wrist watch health monitor to market, the company thought it might be exempt from the Food and Drug Administration’s more arduous clearance process.Still, chief executive Cindy Crump turned to the agency for guidance. “The FDA came back to us with the determination that it is a change in fundamental technology for this type of device, so they said we would need to go through the . . . FDA clearance process,” she recalled.AFrame Digital’s device...
