2006D-0347 Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
FDA Comment Number : EC1
Submitter : Mr. Phil Ferraro Date & Time: 09/22/2006 08:09:11
Organization : self
Category : Individual Consumer
Issue Areas/Comments
As someone who has had a radical prostectomy for prostate cancer and an engineer involved in writing equipment specifications (not for medical devices) I would like to pass along a comment based on my observation. I beleive that the guidelines you produce for medical test equipment should specify a minimum level for the paramter they test. For example, when I have my PSA checked, the answer varies from lab to lab. The lab I have to use depends on my ionsurance company and I can't always get the same machine. Bacause my prostate was removed, I should have a zero PSA. However, machines can't measure zero, some machines can measure a minimum of 0.1 and others can measure 0.01. That's a big difference for me. The guideline you are producing should require a minimum level they are required to measure and they all should be consistent.