Docket Management
Docket: 01N-0051 - Adverse Event Pilot Program for Medical Devices and Blood Products
Comment Number: EC -1

Accepted - Volume 1

Comment Record
Commentor Mr. J. Scott Hall Date/Time 2001-06-21 18:21:15
Organization BIOTRONIK, Inc.
Category Individual

Comments for FDA General
5. General Comments The user facilities will be afforded the option of using an electronic format of the 3500A form which contains additional fields to be completed or a manual version of the 3500A. As well the user facilities are required to report deaths, serious injuries and malfunctions to the manufacturer. In regards to the electronic format of the 3500A; how will this information be relayed to the manufacturer? Will the FDA send the information to the manufacturer or will the user facility be required to printout a hardcopy and mail this to the manufacturer?

EC -1