[US, FDA] List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools)

A companion diagnostic device can be in vitro diagnostic (IVD) device or an imaging tool that provides information that is essential for the safe and effective use of a corresponding therapeutic product. Below is a table of cleared or approved companion diagnostic devices (in vitro and imaging).

 

The use of an IVD companion diagnostic device is stipulated in the instructions for use in the labeling of the diagnostic device. The IVD companion diagnostic devices included in the first table below are indicated for a specific therapeutic product(s). Some IVD companion diagnostic devices are indicated for a specific group of oncology therapeutic products (see FDA's guidance document, Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products, for more information on group labeling). The second table below lists companion diagnostic devices with group labeling indications.

 

In addition, the use of an IVD companion diagnostic device is stipulated in the labeling of the therapeutic product, as well as in the labeling of any generic equivalents and biosimilar equivalents of the therapeutic product. In all cases, the therapeutic product label should be referenced for specific information about the use of the therapeutic, including use of a corresponding companion diagnostic.

 

For a list of all FDA cleared or approved nucleic acid based tests, see Nucleic Acid Based Tests.

 

 

List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) | FDA

List of Cleared or Approved Companion Diagnostic Devices

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