2004D-0343 - Draft Guidance for Industry and Food and Drug Administration Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment; Availability
FDA Comment Number : EC11
Submitter : Mr. Bruce Boggan Date & Time: 11/09/2004 02:11:11
Organization : Valley Regional Medical Center
Health Professional
Category :
Issue Areas/Comments
While current standards pass the Six Sigma Test, inacting a process that will consume vast resourses, the new Fire Damper test schedule being imposed should pass tests to be a reliable assertion. Anything short will be considered politicaly biased. There is yet to be published tests, testing methodolgy, or scientific evidence to prove the need for increased schedules.