Standardized Device Labeling? CDRH Studies Practitioner Perceptions
This article was originally published in The Gray Sheet
Executive Summary
The format of device labeling is controlled by the individual manufacturer, but CDRH is exploring whether health care practitioners can more easily find information from a more standardized device label template that includes a short-summary section. Industry advocates are skeptical that broad-scale standardization is feasible due to the diversity of devices and device users, but companies are assisting in the center’s plans to perform a cognitive study of clinicians this summer.
You may also be interested in...
CDRH Sets Date To Examine Patient-Focused Device Labeling Policies
The device center will convene a meeting at FDA headquarters in September to discuss all facets of device patient labeling.
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.
Quotable: Words Of Wisdom From Our Recent APAC Coverage
Scrip's APAC team selects notable quotes from recent interviews, conferences and other coverage to highlight the views of senior executives and officials on the major topics facing the biopharma sector in the region.