FDA Seeks Feedback on Patient Labeling

July 24, 2015

Patient labeling for medical devices will take center stage at a September FDA workshop as the agency considers updating industry guidance on the topic.

Scheduled for Sept. 29 and 30 at the FDA’s White Oak campus in Silver Spring, Md., the workshop will focus on the content, testing, use, access, human factors considerations, emerging media formats, and promotion and advertising of patient labeling, according to a Federal Register notice. The agency expects to hear from advocacy groups, academic and professional organizations, industry, standards bodies and government agencies.

Patient labeling includes information intended for a lay audience and is supplied in formats such as brochures, leaflets, user manuals, video or audio recordings and physical or online media. It is intended to ensure that devices are used safely and effectively. The agency previously issued guidance on patient labeling in April 2001 that suggested content, including descriptive and operating information.

In advance of the workshop, the FDA is seeking feedback on the following issues: current trends in device labeling; risk and adverse outcomes associated with device labeling; labeling challenges that affect clearance or approval; opportunities for stakeholders to work together to address labeling needs; and potential changes to current guidance and standards to enhance labeling.

Interested parties may comment through Oct. 30, 2015.

Read the Federal Register notice at www.fdanews.com/072715-labeling-workshop.pdf.
— Elizabeth Hollis