|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|
| 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.