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Medical Devices / Regulatory Affairs

Industry Seeks a More Device-Specific Off-Label Communications Guidance

April 25, 2017
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Devicemakers say FDA’s draft guidance on off-label communications is a good start, but is focused too much on drugmakers.

AdvaMed wants additional, device-specific examples in the guidance “that recognize the unique nature of medical devices, to promote understanding of how the guidance applies to medical devices.”

The industry group also requests that FDA outline additional types of communications that are consistent with FDA-required labeling and do not introduce a new intended use. Examples could include information regarding the use of a medical device in a specific anatomical location, subset patient population, or surgical procedure where the device has been approved or cleared for a general use.

The FDA issued the draft guidance for public comment, along with a memo ruling that the First Amendment does not exempt manufacturers from FDA oversight of off-label communications.

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