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An Online Labeling Repository? Device Firms Are Lukewarm At Best

There is little support among device makers for FDA’s proposal to launch an online labeling repository to help patients and caregivers use devices. But an influential pediatrician organization urges the agency to move full-steam ahead.

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...

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