Good day Anon,
Generally, no a process risk assessment like a FMEA would not not be needed for a Traditional 510(k) submission. It may depend on the device and content of the submission, but I personally have not submitted a process risk assessment with a 510(k) submission. There may be information extracted from a process risk assessment which is provided in the submission, but not necessarily a full document.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
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Original Message:
Sent: 16-Apr-2024 11:06
From: Anonymous Member
Subject: IVD - 510(k) and Process FMEA
This message was posted by a user wishing to remain anonymous
Hi
Is a process FMEA required for a Traditional 510(k) submission?