This guidance is a good and safe approach in a general point of vue but unfortunately, it should not be applied to analyses performed in the context of organ transplant and stem cell graft. These fields are under constant developments and deeply rely on RUO products. Application of this guidance to these two fields would be prejudicial for patients and could lead to decrease the number of grafts, decrease the accuracy of the available testing and so to increase patient's mortality. A recommendation should be made to exclude RUO products used for organ transplant and stem cell graft from the guidance.
Lucie Richard - Comment
This is comment on Notice
Draft Guidance for Industry and FDA Staff: Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions; Availability
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