2004N-0535 - Agency Information Collection Activities; Proposed Collection; MedWatch: The FDA Medical Products Reporting Program; Comment Request
FDA Comment Number : EC5
Submitter : Mr. Mark Yale Date & Time: 03/01/2005 07:03:07
Organization : Ethicon Inc.
Device Industry
Category :
Issue Areas/Comments
The proposed changes to the Medwatch form pose a greater burden on companies using computer systems to manage complaints and generate Medwatch forms than is described in the estimated burden table 1. This arise due to the forms being hardcoded into many systems, thereby requiring software change to modify. While this is only a one time cost for each change, these cost are significant.

For example, the change made in 2004 to add sections D8 and D9 required Ethicon to make a software revision change. This change included adding tables to database to capture D8 and D9 information, changes to capture forms within the complaint application and changes to the database mapping used to automatically populate the Medwatch form from the complaint file contents. Additionally Ethicon needed to get pre-approval from FDA prior to implementing our Medwatch form changes to add sections D8 and D9. Overall cost of this effort was approximately $8000 for the software code change and over 100 man hours for CSV and documentation changes.

The proposed changes to the Medwatch form are significantly more complicated than the 2004 change and we have concerns about this change following on the heels of the 2004 change. Since the proposed form re-structures much of where information goes, this will require a significant software upgrade for us, at least an order of magnitude greater than the 2004 change. As a result of this we believe that the overall cost to industry does require further investigation before propsed changes are made and the cost benefit of the changes be made based on not only ongoing cost, but the one time change costs as well.

Mark C Yale
Worldwide Customer Quality (WCQ)
Ethicon Inc.