Hi Anon,
This is a good topic to bring up to get other members' current experiences as there is definitely some disruption happening in this space. The MDSAP procedure you posted is limited to remote auditing of only one chapter of the audit (Device Marketing Authorization and Facility Registration Process).
Our MDSAP surveillance audit is scheduled for Tuesday - Thursday of this week. I was informed last week that the audit was switched to a remote audit. It appears that each AO is creating a covid-19 mitigation plan, with some audits being delayed and some being done remotely. In my case, audits that were delayed are delayed until at least the end of May. We're a small team with some employees quarantined working off-site that will be participating in the remote audit, remotely. It's going to be a unique experience!
Definitely reach out to your AO to get their mitigation plan, determine if your upcoming audits will be affected and how you can begin to prepare for a remote audit.
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Brittany Gibson BSc
Director, Quality and Regulatory Affairs
Winnipeg MB
Canada
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Original Message:
Sent: 22-Mar-2020 14:28
From: Anonymous Member
Subject: MDSAP Pilot Program
This message was posted by a user wishing to remain anonymous
Hello all,
Hoping you and yours remain safe and healthy!! I realize there are many more pressing concerns everyone is dealing with right now, so please excuse the "business as usual" question.
The small med-tech (SaMD) company I work for has been struggling to understand whether the newly announced (Jan 2020) MDSAP Remote Pilot program can be applied for us due to Coronavirus concerns. (Our office is located in one of the US epicenters). Has anyone heard of this going forward yet?
MDSAP AU P0036.001 Remote Auditing Pilot Program [fda.gov]