2004N-0527 - Medical Device Reporting: Plain Language
FDA Comment Number : EC1
Submitter : Mr. Robert Zoletti Date & Time: 03/09/2005 05:03:16
Organization : Cortek, Inc
Device Industry
Category :
Issue Areas/Comments
GENERAL
GENERAL
The guidance document for base line reporting states:

An annual update to a baseline report does not have to be submitted if, during the 12 month reporting period, there were no changes and/or additions made to the information submitted in the initial baseline report, any interim update reports or annual updates.

This is not described in the regulation.