FDA/device industry meeting
This article was originally published in The Gray Sheet
Executive Summary
FDA's Center for Devices and Radiological Health meets with device industry representatives to discuss the center's product review program. Among the topics addressed at the Jan. 13 session were steps to reduce the backlog of pending 510(k) and premarket approval applications. A report on the backlog was presented by FDA. The meeting was the fourth FDA/industry exchange meeting that has been held since June ("The Gray Sheet" Nov. 30, p. 8). FDAers at the recent session included CDRH Acting Director Elizabeth Jacobson and Office of Device Evaluation Acting Director Alan Andersen. Industry reps included officials from the Health Industry Manufacturers Association, the National Electrical Manufacturers Association, Johnson & Johnson, Baxter, Siemens and General Electric....