An update from the Hearing Industries Association (HIA) reports that various medical device manufacturers and associations, including AdvaMed, have filed comments with the Food and Drug Administration (FDA) urging the agency to revise its Draft Guidance for companies that send messages about their medical devices via Twitter. The FDA’s document, “Guidance for Industry Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices,” has drawn criticism from different groups, including some hearing aid manufacturers. The criticisms are in reference to how risks are conveyed and perceived via character-limited social media platforms like Twitter and others.
The HIA reports that AdvaMed had noted that not all devices carry the same level of risk, and that the FDA should consider allowing a combination of links and appropriate introductory language to better balance how any risk is perceived. The Pharmaceutical Research and Manufacturers of America (PhRMA) have further argued that the Draft Guidance violates the First Amendment and sets untenable requirements for using platforms such as Twitter. The PhRMA has reportedly suggested that the Draft Guidance needs a thorough revision.
The FDA Draft Guidance, first issued on June 17, 2014, explains how companies can promote their products on social media platforms like Twitter within the 140 character limit of a “tweet.” The document recommends, among other things, that each individual message or “tweet” should include the product name, its indication, the most serious risks associated with the product, and a hyperlink to a destination (such as a landing page) that is devoted exclusively to the communication of risk information about the product.
For more information about the FDA’s Draft Guidance, visit the FDA website.
Source: Hearing Industries Association (HIA)
Link：Device Manufacturers Criticize FDA Draft Guidance for TwitterREF: Hearing Aids, Hearing Aids Supplier , ITE hearing aids
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