6/25/2013

The FDA's proposal to harmonize U.S. medtech labeling rules with ones in Europe has encountered pushback from AdvaMed because it mandates what the association sees as unneeded additional text. Requiring firms to explain in an accompanying glossary each standardized symbol used on device labels is unnecessary because symbols are "inherently likely to be read and understood by the ordinary individual under customary conditions of purchase and use," the group said.

Related Summaries