FDA states that for its medical device inspection program, it leverages information shared by trusted foreign regulatory partners through mutual recognition and confidentiality agreements. FDA says that a way it does this is through the Medical Device Single Audit (MDSAP) program. But MDSAP is of course limited in regional scope to just the participating countries (Australia, Brazil, Canada, Japan, and the U.S.). My understanding is that FDA also interfaces with regulatory agencies from other regions beyond the MDSAP regions as needed in the interest of U.S public health.
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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: 19-May-2021 14:39
From: Ed Panek
Subject: FDA inspection Updates
Resiliency Roadmap for FDA Inspectional Oversight
This document contained the language "Leveraging information shared by trusted foreign regulatory partners through mutual recognition and confidentiality agreements."
Is this only for Pharma or is this also for Med Device?
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Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani
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