Hello,
No, there is no way to get this information from another company's submission except through FOI Act request. And good luck with this request as this information, if you can even get it, is usually redacted quite heavily. Generally, if you need to know what issues the predicate device had to address, this would be included in the 510(k) Summary.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 12-Oct-2020 09:05
From: Ginger Glaser
Subject: Additional Information Requests from FDA
Generally no, though sometimes they ask you for an MDR supplement which would be in MAUDE. Also, I expect you could get them through FOIA, if you knew what to ask for specifically.
g-
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Ginger Glaser RAC
Chief Technology Officer
MN
Original Message:
Sent: 09-Oct-2020 02:07
From: Anonymous Member
Subject: Additional Information Requests from FDA
This message was posted by a user wishing to remain anonymous
I know that Medical Device Reports are searchable in the Maude Database, but is there a place to search for Additional Information Requests (AIs) when the FDA requests clarification or additional information from manufacturers subsequent to the filing of MDRs?
Short version - Are AIs published ?
Thank you in advance of your consideration and help.