We fill it out and include it as an appendix. We believe it not only helps the reviewer, but it's also a double-check for us to make sure everything we intended to include is, in fact, there.
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Stephanie Mays
Senior Regulatory Affairs Specialist
Redmond OR
United States
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Original Message:
Sent: 22-Oct-2019 03:39
From: James Davis
Subject: Refuse to Accept Checklist
Hi All.
I have noticed in some 510(k) submissions that people include a completed copy of the Refuse to Accept checklist, is this standard practice? I guess that people do this to aid the FDA reviewer but was unsure if this was expected to be done for each submission?
Thanks
James
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James
Head of QARA
UK
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