Using the phrase "Approved by FDA" in Marketing and Advertising Material

Michael Malis

Quite Involved in Discussions
#11
:applause:
Heh. Hey, it's free advice, you don't like it, that's OK. :)

As a final thought, though, there's a voluminous public record of FDA actions against companies on this specific issue.
:applause: yes, for the last year I just found 13 Warning letters just on the Medical device side...
 
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M

MikeEmergo - 2010

#12
FDA doesn't approved medical devices, they obtain "clearance"

Maybe you saw this for a PMA or drug as "Approved by FDA" on television..
 
B

bikeshox

#13
Would "100% Authentic" be OK for use in marketing/trade show materials? In my mind its OK because the claim is that the product is what we say it is, not a counterfeit.
 

Michael Malis

Quite Involved in Discussions
#14
Would "100% Authentic" be OK for use in marketing/trade show materials? In my mind its OK because the claim is that the product is what we say it is, not a counterfeit.
Short answer is "No".
What does this mean "100% Authentic" and what do you claim to be authentic?

What authentic to you maybe not authentic to someone else...
 
M

MIREGMGR

#15
Would "100% Authentic" be OK for use in marketing/trade show materials? In my mind its OK because the claim is that the product is what we say it is, not a counterfeit.
I differ with Mike on this one...I think the answer is that the particular subject statement, whether comprehensible or not, isn't prohibited.

(Unless of course the context is such that "authentic" will be perceived to refer to a disallowed claim or statement.)
 
B

bikeshox

#16
The explanation I received was marketing would use "100% Authentic" in trade show materials to claim our product is the real product, in a market where there are copies or often times counterfeit.
 

Michael Malis

Quite Involved in Discussions
#17
The explanation I received was marketing would use "100% Authentic" in trade show materials to claim our product is the real product, in a market where there are copies or often times counterfeit.
My concern was related to perceived claim...
Also how about the use of "original"?
 

Watchcat

Trusted Information Resource
#19
Is it not the case that Class III devices can be FDA "approved" but Class II are "cleared".
That's the theory. I just posted the attached on LinkedIn last week It is tip of the iceberg when it comes to actual practice, by both industry and CDRH. It is an update of a cartoon I posted a couple of weeks ago, after CDRH announced it had “authorized” a De novo device. I posted the first one without comment, not my usual habit, and I expect a lot of people weren’t sure why I was Rowwrrring. Now that CDRH has done it again, I took the opportunity to explain....
 

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Watchcat

Trusted Information Resource
#20
PS This subforum addresses FDA regulation of food and drugs. If you have a question about FDA regulation of medical devices, you would probably get a better response if you posted it in that subforum.

PPS Also, in case you missed it, the last response to this thread was posted in 2011. That's not inherently a problem, since new posts still get visibility, but often people prefer to post in more recent, active threads.
 
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