FDA Draft Guidance on Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices

Today’s Federal Register announces availability of the draft guidance, “Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices.” This draft guidance, when finalized, is intended to update and provide clarity on the Replacement Reagent and Instrument Family Policy.  When finalized, this guidance will supersede the guidance entitled “Replacement Reagent and Instrument Family Policy,” issued on December 11, 2003. This guidance includes recommendations and information specifically regarding:

•Manufacturer’s initial considerations for determining whether the Replacement Reagent Policy or Instrument Family Policy are applicable;

•The Replacement Reagent Policy and Instrument Family Policy;

•Illustrative scenarios and examples; 

•Labeling considerations; and

•Clinical Laboratory Improvement Amendments (CLIA) categorization when the manufacturer determines that a 510(k) is not needed.

FDA believes this guidance is important for public health as it promotes more timely availability of a wider array of clinical laboratory tests for patient benefit.

This draft guidance will be open for public comments in the Federal Register notice for 90 days under docket number FDA-2017-D-6765.   

Thank you,

Food and Drug Administration

Center for Devices and Radiological Health