This message was posted by a user wishing to remain anonymous
Thanks for sharing the warning letter. I've copied the text related to promotion of FDA approval below:
The Contour is also misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because representations on your firm's website create an impression of official approval of the device and are misleading. In addition, 21 CFR 807.97 states that any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding. Your website contains such representations. For example, your website states: "VevazzTM Contouring is a clinically proven non-invasive fat loss treatment that is pain free that doesn't require recovery time, plus is natural, safe, effective and FDA approved" and "Natural. Safe. Effective. FDA Approved." Further, under an "FDA-approval" tab, your website states:
- "FDA approvals obtained by Vevazz:
1. Class 1 Device: FDA registered for adjacent treatment of obesity
2. 510(k) Clearance: *FDA Cleared for Pain and Inflammation, as well as Immediate Fat Loss and Body Contouring Only. for Pain and inflammation, some of the symptoms of Neuropathy
3. Body Contouring: *FDA Cleared for Pain and Inflammation, as well as Immediate Fat Loss and Body Contouring Only. for 510k for immediate (1 visit) Body Contouring results"
In addition to misbranding, these statements further support the false impression that FDA has evaluated and cleared the Contour for the unapproved uses described above.
One thing to keep in mind regarding the applicability is that they used the word "approval" rather than "cleared," and because they listed indications that earlier in the warning letter, the FDA said they didn't seem to have marketing authorization for. FDA states in the regulation that one should not suggest "cleared" means "approved."
I just point that out because I've seen on many product websites, in small print, a mention of the 510(k) number, which is good to know.
Original Message:
Sent: 22-Jan-2020 15:53
From: Ginger Cantor
Subject: Device Ads and Promotions
Hello Yamini,
So without being able to know the full context of your device, position, etc. and because I am not a lawyer, I don't really want to give you advice you might consider being legal advice. That is beyond the scope of what I can advise on, and this is really an area where I consult lawyers, since it is so grey.
I really suggest you work with your legal counsel if/how you try to promote a 510(k), because there is risk here, especially risk of competitors filing a claim against you.
I attached yesterday's warning letter from FDA for VeVaaz... This was a long WL, but in the middle section, there is prominent warning about FDA objections to the company misleading and thus mis-branding based on promoting their 510(k).
If you don't have legal counsel to advise on how/if to do this, I can suggest a couple:
I have referred my clients when necessary to external FDA Regulatory counsel here in my Twin Cities area that I respect, Gardner Law Advertising and promotion issues are one of their specialty areas. I also refer to Pathmaker FDA Law, their principal counsel (Amy Fowler, JD) collaborates with Gardner Law.
Here are their websites:
https://gardner.law/
http://www.pathmakerlaw.com/
Good luck.
Ginger
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Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
Original Message:
Sent: 22-Jan-2020 15:26
From: Yamini Nidumolu
Subject: Device Ads and Promotions
Hi Ginger,
Actually I am in the same page with Anon. My marketing team at my company want to market an 510K approved IVD product as "FDA Cleared".I see that it is misbranding. What i understand with the conversations on this topic is even it is a 510K approved product it cannot be marketed as "FDA Cleared"and if have to market the product, what can be done instead of "FDA Cleared".
Can you share some information on this subject with relevant links to prove the point?
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Yamini Nidumolu
Bellevue WA
United States
Original Message:
Sent: 19-Jan-2020 12:56
From: Ginger Cantor
Subject: Device Ads and Promotions
Hello all,
Please look at 21 CFR 807.97, misbranding by reference to 510(k). It is also misbranding.if you refer to having an establishment registration.(see 352 of the US Code).
You have to do a lot of tap dancing if you use the 510(k) in your advertising. Surely your competitors will be watching, even if FDA doesn't have the resources to do so.
This has often been answered here.
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Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
Original Message:
Sent: 19-Jan-2020 12:13
From: Glenn Byrd
Subject: Device Ads and Promotions
Anon,
This is a challenging question because FDA has very limited regulations around medical device promotion in general. FDA has authority over restricted device labeling and advertising, but FTC has jurisdiction over non-restricted device advertising while FDA retains authority over non-restricted device labeling.
I have seen numerous instances of "FDA cleared" being part of the promotional content for certain devices with NO FDA enforcement around it. One must be very careful not to interpret FDA public statements as "regulation" because such statements are simply podium policy and not enforceable under the FD&C Act if not covered by regulation.
A very good article from 2018 provides some excellent insights into this question - see following link:
https://www.policymed.com/2013/11/fda-the-differences-with-pharmaceutical-and-device-promotion-standards.html
Sincerely,
Glenn Byrd
President, GByrd Ad-Promo Solutions, LLC
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Glenn Byrd, MBA
President, GByrd Ad-Promo Solutions, LLC
President, RAPS Board of Directors
Woodbine MD
United States
Original Message:
Sent: 16-Jan-2020 17:29
From: Anonymous Member
Subject: Device Ads and Promotions
This message was posted by a user wishing to remain anonymous
Ladies and Gentlemen,
Can you put "FDA-cleared" on promotional material related to your 510(k) cleared device? How about your device labeling?
Thanks,
Anon