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Statement to the House Subcommittee on Health Committee on Energy and Commerce Re: Medical Device User Fee and Modernization Act (MDUFA)

Unless there is increased attention to post-market safety, Consumers Union does not support the FDA’s proposed MDUFA II application processing goals, which would increase the number of applications to be processed by the FDA within a predetermined amount of time. The MDUFMA II processing goals do not appear to be supplemented with additional safety measures and these goals may substitute patient safety for industry speed. Consumers Union also disagrees with the FDA’s recommendation that would allow accredited third parties to conduct facility inspections indefinitely with little interference and oversight by the FDA.

IssuesHealth