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FDA Urged To Simplify Device Labeling At Recent Gathering

FDA heard plenty of input on labeling design and use at a recent two-day public workshop, with safety and usability issues highlighted.

Device firms and patient advocates united at a Sept. 29-30 FDA workshop to ask the agency for simpler, clearer device labeling requirements.

The public workshop held at the agency’s Silver Spring, Md., headquarters was a forum for FDA officials and stakeholders to discuss possible changes to the agency’s 2001 guidance on device labeling targeting patients. Specific issues on the table include identifying the key elements of patient labeling; how device descriptions could be most useful; and the use of appendices and references

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