I have a client working with a vendor to conduct welding testing, and the vendor is claiming that welding parameters are confidential and will be redacted within reports. In addition, they propose redacting specific details from the validation protocol and report, INCLUDING process parameters. They will only provide a test result.
I have never run into this before - and I've been around a long time. This testing is for a PMA product which will likely be a panel track submission.
Has anyone successfully shepherded a PMA submission through FDA with this scenario? I'm wondering if we'd have to have the vendor provide these details directly to FDA.
Thanks in advance,
Karen
------------------------------
Karen Bannick MA, FRAPS, RAC
Principal & Founder
Bannick Consulting Alliance
karen@bannickconsulting.com------------------------------