Medical Industry Fears Device ID Rule Would Drive Up Costs

Law360, New York (August 17, 2012, 4:48 PM EDT) -- The U.S. Food and Drug Administration has tried to head off industry opposition to upcoming identification requirements for medical devices by making the proposed rule flexible, with several potential exemptions, but industry experts say there is still major concern about just how much compliance will cost.

The FDA released its long-awaited proposed rule in July, five years after Congress passed a law ordering the agency to require unique identifiers on medical devices. Under the proposed rule, the packaging of most medical devices will have to carry...
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