Docket: 02N-0456 - Determining Hospital Procedures for Opened-But-Unused, Single-Use Medical Devices Comment Number: EC -13
Accepted - Volume 1
Comment Record
Commentor
Mr. David Jagrosse
Date/Time
2002-09-17 12:37:06
Organization
Middlesex hospital
Category
Health Professional
Comments for FDA General
Questions
1. General Comments
It is my opinion that opened-but-unused, single use devices should be reprocessed by a third party reprocessor or hospital only with 510k approval for that item.