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GUIDANCE DOCUMENT

Molecular Diagnostic Instruments with Combined Functions Guidance for Industry and Food and Drug Administration Staff November 2014

Download the Final Guidance Document
Final
Docket Number:
FDA-2013-D-0258
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

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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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2013-D-0258.

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