In 2003, FDA issued updated guidance on the “Replacement Reagent and Instrument Family Policy” for in vitro diagnostic (IVD) devices. The 2003 guidance described a mechanism for manufacturers to follow when applying an assay that was previously cleared for use based on performance characteristics with a specified instrument, to an additional instrument that was previously cleared or that is a member of an instrument family from which another member has been previously cleared. Through the approach described in the 2003 guidance, manufacturers establish sufficient control to maintain the level of safety and effectiveness demonstrated in the cleared device for these types of modified devices, when evaluated against predefined acceptance criteria using a proper validation protocol, without submission of a premarket notification (510(k)).

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. To ensure that its full benefits are realized, FDA is providing additional clarity to help manufacturers and FDA better apply the concepts in this guidance.