Fish's Keith Barritt Quoted in Bloomberg BNA's Medical Devices Law & Industry Report "FDA Performance, Medicare Coverage, Pressure From Excise Tax on 2014 Agenda"


Reproduced with permission from Medical Devices Law & Industry Report, 8 MELR 63 (1/22/2014). Copyright 2014 by The Bureau of National Affairs, Inc. (800-372-1033)

Keith A. Barritt (DC) was quoted in Bloomberg BNA's Medical Devices Law & Industry Report.

The goal of the report is to promote safety and innovation and reduce regulatory duplication, attorney Keith Barritt, of Fish & Richardson P.C. in Washington, told Bloomberg BNA. "While streamlining regulatory approvals is certainly desirable, time will tell if there are really any synergies that can be found to minimize the burden on manufacturers from obtaining marketing authorization considering the different functions of the FDA and the FCC [Federal Communications Commission] in particular,'' he said.


And Barritt said, "A related issue is Congressional efforts to limit FDA regulation of mobile medical applications and other software. The FDA has long held that software can fall within the statutory definition of a 'medical device,' and it would likely take a change in definition to change the FDA's position.''


"Excluding software from the FDA's regulatory jurisdiction could have dramatically dangerous consequences, considering that more and more functionality is software-based rather than hardware-based,'' he added.

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