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Home » Risk-Averse FDA Strangles 510(k) Process, New Citizen’s Petition Charges
Risk-Averse FDA Strangles 510(k) Process, New Citizen’s Petition Charges
January 11, 2013
A citizen’s petition filed by Minneapolis law firm DuVal & Associates challenges several aspects of the 510(k) process, charging that current practices effectively overstep CDRH’s statutory boundaries and insert the agency into the practice of medicine.