CDRH Annual Report - eSubmitter

JoshuaFroud

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#1
Hi All

I am currently attempting to generate my first annual report using eSubmitter. The person previously responsible for this task is no longer available to assist which has left me somewhat blind as I have never used the software or completed a CDRH annual report before.
Currently, I have completed the majority of the form but have two questions;

1) General Annual Report: Part 4: Procedures For Quality Control and Testing: The initial report(s) provided to CDRH for each model family currently in production have been reviewed and the procedures contained within are up-to-date, complete and accurate? Yes/No - I have reviewed all the procedures and everything currently in use is up to date, the content of the initial submission is however probably no longer accurately reflecting current practice (I have not been able to locate the initial submission as it was done way before my time, however, I know the procedures have been revised since this date)[FONT=&quot]
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2) General Annual Report: Part 3: Current Product Tabulation: Looking through the previously submitted annual reports sent in by my company these have been free form letters that have listed the systems installed in the US during the 12months the report covers along with a statement the product range has not changed. What exactly is this section asking for? Should I be populating it with the details of individual systems manufactured (we make capital equipment) i.e. ACME100 Serial 097 and the "Plant" section at the bottom be where it is installed or should this be more generally about each product type, i.e. ACME100 11 units produced at ACME Site 1.

Thanks in advance! [FONT=&quot]
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