2006D-0347 Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
FDA Comment Number : EC11
Submitter : Dr. H. Barton Grossman Date & Time: 11/27/2006 09:11:31
Organization : M. D. Anderson Cancer Center
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
Minor:
On page 2, ASR is used as an acronym before it is defined.

More significant:
Page 4 - The example in paragraph 2 regarding which devices are class II and which require PMA is not good. Predicting risk of cancer recurrence is likely to be an indication for chemotherapy. Perhaps, what you meant for the PMA is a test that indicates the need for a specific drug.
Page 5, last paragraph - The global comment about reporting contributions to serious injury will be very difficult to accomplish. For example - A device may indicate the need for chemotherapy. However, the patient does not have a clinical response to treatment but experiences the expected toxicity of the recommended drug. It could be argued that the device contributed to a serious injury. Alternatively, no device will work perfectly and this scenario is a likely outcome in a proportion of patients getting the test. Perhaps the best way to address this issue is to require post- marketing follow-up of a defined series of patients including outcome following device recommendations.