Advertising a Class II Medical Device pending 510(k)

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M

MIREGMGR

#2
"Advertising" usually means "offering for sale". That's not permissible for a device requiring FDA approval of premarket notification and not yet having received that approval, except in narrowly defined conditions.

See this recent thread for discussion of related topics.
 
T

tleyva

#3
Thanks for the reply. The info I have found to date supports your statement. I have heard that a firm may advertise the device as long as it is clear to the public that the device is pending 510k approval (e.g. a label blatently stating this) and the firm may not take orders, or be prepared to take orders, that might result in contracts of sale for the device unless limited to research or investigational use.
 

Michael Malis

Quite Involved in Discussions
#4
Thanks for the reply. The info I have found to date supports your statement. I have heard that a firm may advertise the device as long as it is clear to the public that the device is pending 510k approval (e.g. a label blatently stating this) and the firm may not take orders, or be prepared to take orders, that might result in contracts of sale for the device unless limited to research or investigational use.
You can't advertise!
However, if you planning to bring you device to the medical show and your product is really pending a 510(k) (i.e. you made your submission to the FDA), you can show device to the public as long as all your literature identifued on all pages that it is "pending 510k clearance". This include all posters and all literature.
And you still can't take orders...
 
P

Phil Fields

#5
I am looking for guidance concerning advertising a class II medical device pending 510k.
You could always call your contact at the FDA, they would probably have the best guidance. The FDA offer the answer your company wants to hear, but you that would be your company’s decision to follow their guidance or not.

Phil
 

Michael Malis

Quite Involved in Discussions
#6
You could always call your contact at the FDA, they would probably have the best guidance. The FDA offer the answer your company wants to hear, but you that would be your company’s decision to follow their guidance or not.

Phil
"..they would probably have the best guidance..."
I am not sure about this...FDA is busy with more important issues, like Food and Drugs Quality problems that we have in US.
Plus, the giudance is very clear on this and does not leave any room to understand this the wrong way...
 
P

Phil Fields

#7
"..they would probably have the best guidance..."
I am not sure about this...FDA is busy with more important issues, like Food and Drugs Quality problems that we have in US.
Plus, the giudance is very clear on this and does not leave any room to understand this the wrong way...
Michael,
Thank you for the input. My points, though not exactly spelled out, go to the source if you are not sure. I'm sure the people here at the Cove are good, but if I'm going to be in violation of the FDA regs (law), I think it would be best to ask the FDA directly for their interpretation.

Phil :)
 
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