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Standardized Device Labeling? CDRH Studies Practitioner Perceptions

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.

FDA plans to conduct a cognitive study of health care practitioners this summer to advance efforts to standardize the structure and content of medical device labeling. While the device industry is providing advisory assistance for the project, sector advocates remain skeptical that broad-scale standardization for device labeling is feasible or advisable.

Researchers working with CDRH will visit several hospitals in the Washington, D.C., area and also bring clinicians to the agency’s Silver Spring, Md., headquarters to assess how the providers perceive...

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