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

[Marcelo]

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

https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM077295.pdf

 

[lilybef]

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 .

 

[yodon]

... Do you think that using a DOC would be beneficial to the submission? Why? Just looking to start a conversation to get insights .

Definitely a trick question! But definitely worth discussing. I think if you have a DOC with supporting data, it would be beneficial. It gives the reviewer the information in a convenient package.

And I'm sure it's a case-by-case (and reviewer-by-reviewer) situation. For example, if you submit a DOC for 62304 (software), the reviewer may accept it or require to see more info (than what would normally be submitted).

 

[lilybef]