FDA issues draft guidance on research use-only IVDs

FDA issued draft guidance covering the commercial distribution of in vitro diagnostics that are labeled for research or investigational use only. The guidance states that manufacturers "should halt" sales of an IVD intended for research or investigational use if the manufacturer learns that a customer is using the product for non-investigative clinical diagnosis. Comments on the draft are due 90 days after publication in the Federal Register.

FDA noted that the guidance does not apply to laboratory-developed tests (LDTs), even though they are considered IVDs. However, the agency said LDT manufacturers may find the guidance helpful in determining the proper use of IVDs labeled for research or investigational use only. ...