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In Vitro Companion Diagnostic Devices Guidance for Industry and Food and Drug Administration Staff August 2014

Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance is intended to assist (1) sponsors who are planning to develop a therapeutic product1 (either a novel product or an existing product with a new indication) for which the use of an in vitro companion diagnostic device (or test) is essential for the therapeutic product’s safe and effective use and (2) sponsors planning to develop an in vitro companion diagnostic device that is intended to be used with a corresponding therapeutic product.

Specifically, the guidance intends to accomplish the following:

  • Define in vitro companion diagnostic device (hereafter referred to as an “IVD companion diagnostic device”) 
  • Explain the need for FDA oversight of IVD companion diagnostic devices
  • Clarify that, in most circumstances, an IVD companion diagnostic device and its corresponding therapeutic product should be approved or cleared contemporaneously by FDA for the use indicated in the therapeutic product labeling
  • Provide guidance for industry and FDA staff on possible premarket regulatory pathways and FDA’s regulatory enforcement policy
  • Describe certain statutory and regulatory approval requirements relevant to therapeutic product labeling that stipulates concomitant use of an IVD companion diagnostic device when use of the IVD is essential to the safe and effective use of the therapeutic product

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.