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FDA news 14-09-18 - Use of Voluntary Consensus Standards in Premarket Submissions

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  Post Number #1  
Old 14th September 2018, 08:51 AM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
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Look! FDA news 14-09-18 - Use of Voluntary Consensus Standards in Premarket Submissions

FDA Final Guidance - Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices

https://www.fda.gov/downloads/Medica...ampaignId=4054
Thanks to Marcelo Antunes for your informative Post and/or Attachment!

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  Post Number #2  
Old 14th September 2018, 10:34 AM
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Re: FDA news 14-09-18 - Use of Voluntary Consensus Standards in Premarket Submissions

Hello fellow Cove members!

I just was reading this document, and I have some questions on application of the DOC to 510(k) submissions. Do you think that using a DOC would be beneficial to the submission? Why? Just looking to start a conversation to get insights .
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