Standardized Device Labeling? CDRH Studies Practitioner Perceptions
This article was originally published in The Gray Sheet
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.