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Critics Call FDA Third-Party Social Media Guidance ‘Overbroad’

This article was originally published in The Gray Sheet

Executive Summary

Some stakeholders are concerned the agency’s draft guidance is overreaching and could have a chilling effect. AdvaMed recommends FDA consider splitting the guidance into product-specific documents to reference regulations that may apply to industries differently.

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Device-makers that have been reluctant to add product videos to YouTube might need to produce them anyway to counteract inaccurate or even dangerous user videos, one consultant says – but the step isn’t totally without risk. For example, attorney Colleen Heisey questions whether creating online video is the best use of a company’s limited resources: “You have to go viral to have the impact of millions of viewers … so you’re coming up with a digital engagement strategy, and the effort to do that might be better placed elsewhere."

Experts To Industry: Start Implementing Social Media Guidelines Now

While FDA’s oversight and expectations for device makers using social media is still hazy, two experts advise companies to put together policies outlining their interpretation of new agency guidances on the topic and how they plan to comply.

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