Hello Anon,
There is probably not enough information to provide a succinct answer considering what is the device or how the results of the study are being used. However, stating this is a PMA submission, assuming US FDA, you could reach out to the reviewer if you have an IDE or go through a Q-Submission meeting to hopefully answer the question whether it would be accepted in the submission or not.
------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------
Original Message:
Sent: 25-Jan-2023 11:13
From: Anonymous Member
Subject: IVD repro study
This message was posted by a user wishing to remain anonymous
Is it a PMA submission risk for 2 labs to use different DNA extraction methods for the reproducibility study?