HIMA contends the labeling initiatives exceed the agency's regulatory authority and would result in "redundant and bulkier labeling that does not materially improve the professional's ability to use the product safely." The draft guidance would require manufacturers to include a summary of essential information on a medical device label. CDRH said it wanted to promote uniformity and clarity in labeling reviews, to provide greater direction in format and content of device labeling, and to address the issue of health care professionals not reading device labels.
Medical device labeling proposal assailed
The Health Industry Manufacturers Assn. (HIMA) doesn't support the draft guidance on medical device labeling developed by the U.S. Food & Drug Administration's Center for Devices and Radiological Health (CDRH).
Dec 31st, 1997