Pursuant to 21 CFR 807.87, FDA requires that proposed advertising be included in the 510(k). FDA reiterates this in its 1989 labeling guidance publication FDA 89-4203, as well as at FDA's "Device Advice" website. According to the FDA, this includes "...posters...pamphlets...circulars...brochures...etc.", among other articles.
In practice, if no advertising literature has yet been proposed at the time the 510(k) is submitted, then no advertising literature is required in the 510(k). In other words, FDA won't typically force the Sponsor to include advertising literature in the 510(k) as a precondition for clearance.
The most important scenario where a Sponsor should consider including its advertising literature in the 510(k) is when:
a) the literature includes claims that push the boundaries of the intended use / indications for use represented in the 510(k); and
b) the Sponsor wants the added assurance of FDA review and specific clearance for such advertising claims.
Hope this helps,
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Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
Original Message:
Sent: 24-May-2016 11:13
From: Carmen Herraez
Subject: 510k submission - Advertising/Promotion/Labeling materials for Medical Devices
Hello all!
I have a questions regarding the 510k submission. I couldn't find any information regarding the requirements for Advertising/Promotion/Labeling material for medical devices (except for the product label itself). In my case I work with Class II devices.
I am preparing the 510k submission for a new device and I would like to know, what kind of advertising and marketing material does the FDA requires to include in the 510k submission? Do I need for example to submit the brochures? Is there any guidance or regulation listing the required documents? Is there also any guidance with the requirement for developing the advertising material?
Thanks in advance for the help,
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Carmen Herraez
Regulatory Affairs
Acrostak International Distribution Sàrl
Geneva, Switzerland
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