I have not gone through it in detail yet, but I think some of the updates are just to the recently published guidance documents and some edits on wording. With that said, I would recommend if you are compiling a 510(k) that you go through this in detail each line item to "verify" content of your submission.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 25-Feb-2019 09:43
From: Anonymous Member
Subject: 2-21-2019 Refuse to Accept Policy for 510(k)
This message was posted by a user wishing to remain anonymous
https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm315014.pdf
Original Message:
Sent: 23-Feb-2019 22:07
From: Anonymous Member
Subject: 2-21-2019 Refuse to Accept Policy for 510(k)
This message was posted by a user wishing to remain anonymous
Does anyone know what the new requirements are in the Refuse to Accept Policy for 510(k) the FDA releasd 2-21-2019?