Tuesday, April 14, 2015

Standardized Device Labeling? CDRH Studies Practitioner Perceptions

Standardized Device Labeling? CDRH Studies Practitioner Perceptions-thegraysheet: 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.