Advertising a Medical Device before 510K Submission

J

jjjbplo

can anyone point me to information regarding what kind of advertising or promotion is permissable before a 510k is submitted?
 

Ronen E

Problem Solver
Moderator
can anyone point me to information regarding what kind of advertising or promotion is permissable before a 510k is submitted?

Hi,

You might want to have a look here (scroll down to the article "Advertising Medical Devices In the US":

http://medicaldeviceschool.com/Advertising Medical Devices In the US.html

In general, advertising of 510(k)-cleared devices is only allowed under the cleared indicated use. If no 510(k) has been submitted yet, no indicated use could have been cleared, and hence how would you be able to advertise?

Cheers,
Ronen.
 
M

MIREGMGR

In the US, advertising a medical device legally amounts to marketing it, and marketing a medical device that is not exempt from pre-marketing approval or acceptance of a pre-market notification is illegal.

So, the only legally permitted advertising for an uncleared (i.e. not just submitted-510[k], approved 510[k]) medical device in the US is minimal announcements at international-attendee-attracting trade shows where the device will be shown, stating that it may not be sold to US buyers.

Such "not for sale in US" cards are very common at the annual RSNA show, for instance.
 
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