Issue Date: November 12, 2014
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket,
Status: Final
Molecular Diagnostic Instruments with Combined Functions: Guidance for Industry and Food and Drug Administration Staff
This document provides FDA’s current thinking on regulation of molecular diagnostic instruments that combine in a single instrument both approved/cleared device functions and device functions for which approval/clearance is not required. It also provides advice on the type of information that should be provided in a premarket submission for a molecular diagnostic instrument that measures or characterizes nucleic acid analytes and has combined functions. In this document, “combined functions” refers to instruments that serve as a component of an FDA-cleared or approved IVD system but can also be configured by the user for other test purposes, such as basic research.
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