Docket Management
Docket: 01P-0120 - Medical Devices; Needle-Bearing Devices; Request for Comments and Information
Comment Number: EC -6

Accepted - Volume 1

Comment Record
Commentor Miss Alison Brummett Date/Time 2002-06-28 11:47:50
Organization ICU Medical, Inc.
Category Company

Comments for FDA General
Questions
1. General Comments Safety devices should be classified as defeatable or non-defeatble technologies. Many safety features of devices can easily be and are commonly 'overridden' if the Practitioner chooses. An example would be disposable needlefree IV injection sites which require a blunt needle to access, but will still accept a needle.




EC -6