In written comments invited by FDA, device manufacturers Abbott Laboratories, RTI Biologics, Cook Group and Johnson & Johnson ranged from cool to lukewarm on FDA’s idea for an online government repository of medical device labeling.
FDA is considering the repository as a means to give device users, particularly patients and caregivers using devices in the home, access to understandable and accurate information on such things as the intended use of a device, how to operate it and how to troubleshoot problems
