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Is it okay to advertise or display a medical device that is pending a 510(k)?

 

 
   

 

 

 

Yes,  As long as you:

Do not take orders or be prepared to take orders that might result in contracts for it’s sale.

Include caution statements regarding it’s current status

Make the investigational status of the product clear

Never make statements regarding the product’s safety or efficacy

Do not make comparative claims with other medical devices on the market (even ones your company has put on the market)

 

   
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