FDA issues final guidance on replacement reagent and instrument family policy for in vitro diagnostic devices

Aug. 17, 2022
Guidance for Industry and FDA Staff.

The U.S. Food and Drug Administration (FDA) issued this final guidance: Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices. The FDA considered comments and revised the guidance to include point of care in vitro diagnostic (IVD) devices (in certain situations) and flowcharts, updates to examples, and further clarification of terminology.

This final guidance:

  • Replaces the 2003 guidance on the Replacement Reagent and Instrument Family Policy.
  • Incorporates concepts and recommendations from the FDA’s guidance, Deciding When to Submit a 510(k) for a Change to an Existing Device.
  • Provides clarity to help stakeholders better apply the concepts and to ensure the benefits of the guidance are realized.

FDA guidance