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FDA Attempts to Clarify Promotions

NEWS TRENDS


Medical device manufacturers have a chance to respond to FDA's proposed guidelines for advertisements and promotion labeling. The publication of the draft, Guidance for Industry Presenting Risk Information in Prescription Drug and Medical Device Promotion, follows recent pleas for FDA leadership on the issue.

In March, industry group AdvaMed issued voluntary guidelines for medical device advertisements. The Prescription Project has also drawn attention to the issue. In December, citing what it thought were inappropriate YouTube ads for medical devices, the organization called on the agency to issue a guidance.

In the draft, FDA says that it will evaluate medical device promotions using the same "reasonable consumer standard" that it applies to the labeling of dietary supplements and conventional food. It details the specific parts of promotions that it will analyze such as the proportion of benefit and risk information presented, the interplay of audio and visual components, and the use of signals.

The deadline for comments is August 25. The document is available here.


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