Download this free, 130-page Package Development Playbook jam-packed with strategies for success, best practices, and pitfalls to avoid.  Learn more »»
Article |

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 (HIMA) doesn't support the draft guidance on medical device labeling developed by the U.S. Food & Drug Administration's Center for Devices and Radiological Health (CDRH).
Print Reprint
FILED IN:  Machinery  > Labeling
     

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 The draft guidance would require manufacturers to include a summary of essential information on a medical device label.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.

Comments(0)

Add new comment

ADVERTISEMENT
E-BOOK SPECIAL REPORT
42 Best Package Designs
Sign up to receive timely updates from our editors and download this e-book consisting of our editors' picks of most notable package designs. Updated for 2014!
x

Newsletters

Don't miss intelligence crucial to your job and business!
Click on any newsletter to view a sample. Enter your email address below to sign up!
GENERAL INTEREST
PACKAGE DESIGN/DEVELOPMENT
Each newsletter ranges in frequency from once per month to a few times per month at most.