I generally concur with Richard and Anne, and would also point out that 'label' and 'labeling' are defined in the statutory text (FD&C Act),
21 USC 321 (k), (l), (m), and (n), as follows (
21 CFR 801.3 points to this text) - while the wording is focused on the physical label itself, it also discusses advertising collateral that may lead to misbranding (essentially, what was discussed in the thread above).:
(k) The term "label" means a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of this chapter that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper.
(l) The term "immediate container" does not include package liners.
(m) The term "labeling" means all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.
(n) If an article is alleged to be misbranded because the labeling or advertising is misleading, then in determining whether the labeling or advertising is misleading there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article to which the labeling or advertising relates under the conditions of use prescribed in the labeling or advertising thereof or under such conditions of use as are customary or usual.
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Jonathan Amaya-Hodges
Director, Technical Services
Sharon MA
United States
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Original Message:
Sent: 27-Oct-2022 06:36
From: Richard Vincins
Subject: FDA definition of medical device labeling?
Hello Jonathan,
As Anne indicated it pretty much includes anything which is customer facing, e.g. labels, IFUs, directions, manuals, websites, brochures, marketing material. And even such things as social media like youtube. Over the years it has progressed with not only just direct label and instructions for use, but many other materials and information such as brochures and website. This is often not just the United States in this thinking but many other regulatory agencies have the same view.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 26-Oct-2022 15:13
From: Anne LeBlanc
Subject: FDA definition of medical device labeling?
Yes, almost all information you provide, by whatever channel, will fall under the definition of labeling.
https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling
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Anne LeBlanc
United States
Original Message:
Sent: 26-Oct-2022 08:32
From: Jonathan Bemben
Subject: FDA definition of medical device labeling?
What is the FDA definition of medical device labeling? Specifically, would labeling include any material provided to the patient regardless for how it is received? ex information given by doctor, sales representative (brochure, patient implant card, etc).
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