Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

FDA To Survey Clinicians About Adding “Highlights” Section To Device Labeling

This article was originally published in The Gray Sheet

Executive Summary

FDA wants to know what information physicians, nurses and technicians would like to see in a shortened "quick guide" version of labeling as part of an effort that could result in more standardized device labeling.

You may also be interested in...



FDA Outlines Next Steps For Online Repository And Standard Elements For Device Labeling

Industry representatives, health care providers, patients and caregivers gathered April 29-30 to discuss CDRH labeling activities and the agency’s ideas for the future.

FDA Says Pilot On Standard Electronic Labeling For Devices “Didn’t Work”

CDRH’s five-company pilot study on electronic transmission of standard device labeling information spotlighted some serious challenges with the practice, according to a policy advisor at the center.

Regulatory News In Brief

FDA delivers first report on foreign offices to Congress. Agency denies citizen petition on IOM 510(k) panel. More regulatory briefs.

Related Content

Topics

UsernamePublicRestriction

Register

OM001644

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel