LumiThera submitted a de novo request to the FDA to reclassify the Valeda light delivery system as a Class II device for the treatment of dry age-related macular degeneration, according to a press release.
After the FDA reviewed and provided feedback on the premarket approval (PMA) application for the system, which included positive data from the LIGHTSITE III trial, the company decided to pursue the de novo request.
The request reflects the benefit-to-risk profile and provides a path for novel devices to reach the market and special controls to maintain (Read more...)