Proposed FDA rule on use of symbols on device labels gets pushback

06/25/2013 | Clinica (subscription required)

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.

View Full Article in:

Clinica (subscription required)

Published in Briefs:

SmartBrief Job Listings for Health Care

Job Title Company Location
Product Development Manager, Disposable Medical Products
ASAHI INTECC, Orange County CA R&D Center
Santa Ana, CA
Neurovascular Intervention Product Sales Rep, North East
Multiple Locations, SL_Multiple Locations
Vice President of Regulatory Affairs
Pentec Health
Boothwyn, PA
Sr Coordinator Clinical Research (US/TA/00/0073/SL) - 1400000AQX
Santa Clara, CA
Senior Director, Biostatistics
Edwards Lifesciences
Irvine, CA