Source: https://elsmar.com/elsmarqualityforum/threads/fda-labeling-and-advertising-regulations.57842/
Timestamp: 2020-07-04 19:15:52
Document Index: 167202355

Matched Legal Cases: ['art 820', 'art 820', 'art 801', 'art 820', 'art 210', 'art 211', 'art 820', 'art 820', 'art 801']

According to one page on the FDA's website:
"Under the FD&C Act, FDA has regulatory authority over the labeling of all medical devices. However, FDA's regulation of medical device advertising is limited to a subset of medical devices [ie, restricted devices, as discussed later on this page]. The Federal Trade Commission (FTC) regulates the advertising, as opposed to the labeling, of most medical devices under sections 12-15 of the Federal Trade Commission Act, which prohibit false or misleading advertising of certain products that FDA regulates. (Title 15, United States Code [U.S.C.] section 52-55)."
But according to this page on the FDA website:
"According to an appellate court decision: "Most, if not all advertising, is labeling. The term 'labeling' is defined in the FFDCA as including all printed matter accompanying any article. Congress did not, and we cannot, exclude from the definition printed matter which constitutes advertising.""
This seems to be a contradiction to me as to if advertising is separate from labeling (as the first statement implies), or if advertising is a subset of labeling, as the second statement seems to be saying.
I don't see how both statements can be correct... help...?
I would go by the one that was last updated on 12/5/12. The other seems to be testimony before congress that was done on 9/17/08. But to be sure I would check the CFR to see what it currently states.
If you search the FDA Warning letters, you will notice that the FDA is enforcing the ruling that advertising is also considered labeling of a medical device.
Likes: ariannas and Ronen E
Very gray area. My take is that the line is drawn around claims. You can 'advertise' that you sell widgets (presumably cleared for sale by the FDA). But if your advertising says you sell widgets for the treatment of something then you've crossed the line into claims and the FDA gets interested.
The waters got further muddied (IMO) with a recent decision regarding promotion of off-label use (http://www.fdalawblog.net/fda_law_b...conviction-involving-off-label-promotion.html). Previously, that was strictly prohibited and tightly regulated. With this decision, though, the door has seemingly been flung wide open.
L Device Labeling - Stand Alone Symbols of ISO15223 no longer FDA recognized Other US Medical Device Regulations 2 Oct 22, 2014
D FDA Guidance on 'Latex-Free' Labeling Issued Today - March 2013 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7 Mar 11, 2013
I FDA Labeling Requirements for ASR (Antibodies) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2 Aug 8, 2012
A FDA Labeling Regulations - 21 CFR part 801.109(c) vs (d): Prescription Labeling Other US Medical Device Regulations 5 Jul 11, 2012
W FDA Labeling Requirements - Instruction for Use Content 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5 Apr 23, 2012
S New FDA Guidance document released for Promotional Material, Labeling, etc Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1 Jan 30, 2012
B Labeling for FDA and CE Marking EU Medical Device Regulations 1 Mar 1, 2011
E FDA (US Food and Drug Administration) Labeling Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8 Dec 20, 2010
M Recognized Symbols for Device Labeling? 510k to the FDA 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6 Sep 26, 2007
Device Labeling - Stand Alone Symbols of ISO15223 no longer FDA recognized
FDA Guidance on 'Latex-Free' Labeling Issued Today - March 2013
FDA Labeling Requirements for ASR (Antibodies)
FDA Labeling Regulations - 21 CFR part 801.109(c) vs (d): Prescription Labeling
FDA Labeling Requirements - Instruction for Use Content
New FDA Guidance document released for Promotional Material, Labeling, etc
FDA (US Food and Drug Administration) Labeling Requirements
Recognized Symbols for Device Labeling? 510k to the FDA