Within Section 502 of the FFDC Act, advertising for a "restricted" device is required to include a brief statement of the intended uses along with the appropriate warnings, precautions, etc. Note that this is not applicable to a reminder ad.
FDA device personnel review both Class 2 and 3 devices, their expectations for additional labeling such as the indications, have trickled down to the class 2 devices. More than once I have been told that intended use(s) should be on promotional materials unless it is obvious due to the product trade and unbranded names conveying its usage. In fact, other FDA reviewers have requested something akin to the brief statement which is required for higher risk devices. Other RA professionals submitting to others review groups have shared the same information.
Interested in what other device companies are currently experiencing on this topic.
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Carol Cooper RAC
Principal
Libertyville IL
United States
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Original Message:
Sent: 07-May-2018 10:12
From: Marie Murtagh
Subject: Ad Promo Question
Which Regulation sites that the full indication needs to be used in promotional pieces
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Marie Murtagh
Sr. Manager, Regulatory Affairs
Fort Lee NJ
United States
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