FDA holding meetings with industry to gather input on reengineering program.
This article was originally published in The Gray Sheet
Executive Summary
MEDICAL DEVICE REPORTING ABOLITION SUGGESTED BY HIMA MEMBERS at a recent meeting with Center for Devices and Radiological Health topsiders. According to FDA minutes of an April 11 session held at the Health Industry Manufacturers Association headquarters to discuss CDRH reengineering, manufacturers suggested that if FDA cannot establish the usefulness of MDR in protecting public health, it should abolish the program and regulations like MDR and use its staff elsewhere.
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