"The bottom line was that we could go ahead and file the device for a 510(k) application but it sounded like we would have had to take the PMA route and a PMA wasn't in our timeline. Fortunately for us we had a backup plan."

—Dave McMahon, VP of Marketing for Luminous, discussing a strategic decision to change the design of his company's automated glucose sensor due to an FDA decision to require a more stringent PMA for the company's original device, "Despite roadblocks Luminous still in 510(k) path with glucose monitor."