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

Docket Number:
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.

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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

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