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

Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Devices and Radiological Health

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.

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.