Docket Management
Docket: 01N-0267 - Medical Device Labeling Regulations
Comment Number: EC -3

Accepted - Volume 1

Comment Record
Commentor Mr. Stephen Dolle Date/Time 2001-09-11 15:31:37
Organization Patient Advocate
Category Health Professional

Comments for FDA General
1. General Comments The CDRH must do more to provide profesional user and patient user information for the more efficacious use and performance of medical devices. It should incorporate input from special professional and patient user panels. Labeling should be analogous to, yet broader, than consumer devices.

EC -3