Comment Record |
Commentor |
Mr. Stephen Dolle |
Date/Time |
2001-09-11 15:31:37 |
Organization |
Patient Advocate |
Category |
Health Professional |
Comments for FDA General |
Questions |
1. General Comments
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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.
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