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MDR baseline reporting should be implemented on pilot basis, if at all, HIMA tells FDA.

This article was originally published in The Gray Sheet

Executive Summary

MANUFACTURER MDR BASELINE REPORTING REQUIREMENTS should be implemented on a pilot basis, if at all, the Health Industry Manufacturers Association says in Jan. 10 comments on FDA's final rule for device manufacturer and user facility reporting ("The Gray Sheet" Dec. 11, p. 3). HIMA categorically opposes baseline reporting but says that if FDA insists on implementing the requirement, the reporting "should be initiated as a pilot program for a limited number of devices," such as "the top ten devices in terms of number" of medical device adverse event reports "filed with FDA annually."
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