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MEDICAL DEVICE LABELING CLAIMS: BROAD VERSUS SPECIFIC INDICATIONS

This article was originally published in The Gray Sheet

Executive Summary

MEDICAL DEVICE LABELING CLAIMS: BROAD VERSUS SPECIFIC INDICATIONS for use will be addressed in a forthcoming policy statement currently in the works at the Center for Devices and Radiological Health's Office of Device Evaluation. Speaking Sept. 20 at the annual meeting of the Regulatory Affairs Professionals Society in Washington, D.C., ODE Director Susan Alpert, MD, PhD, said the agency's policy is "under development and I expect that you'll hear something on that within the next few months."

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