Yes, you should generally plan and expect that FDA will include finished device contract manufacturing sites in the PAI step of the PMA process for a class III IVD. Those sites need to be divulged in the Manufacturing Information of the PMA submission.
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 01-Jul-2022 16:34
From: Anonymous Member
Subject: PMA Traditional
This message was posted by a user wishing to remain anonymous
Hello,
If a class III IVD product that is under going a PMA submission utilizes different contract manufactures and contract packing facilities who are under their own QSR, do you need to speak to them in the Manufacturing Information of the PMA?