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# Stakeholders Views on Oncology Companion Diagnostic Labeling
- URL: https://www.fdaweb.com/stakeholders-views-on-oncology-companion-diagnostic-labeling/
- Published: 2019-02-19T12:00:00.000Z
- Updated: 2026-09-15T01:05:42.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143409

Pharmaceutical Research and Manufacturers of America has given FDA four points to consider when revising its draft guidance on developing and labeling *in vitro* companion diagnostic devices for a specific group or class of oncology therapeutic products. The association [says](https://www.regulations.gov/document?D=FDA-2018-D-3380-0017&ref=fdaweb.com) that: 

- any final guidance should clarify that class labeling is one potential approach for companion diagnostic development and labeling, but is not the expected or only paradigm available to therapeutic product and diagnostic sponsors;
- any final guidance should provide further discussion on the circumstances in which FDA believes class labeling may be warranted;
- any final guidance should clarify that class labeling would be appropriate only where the diagnostic company and a therapeutic product sponsor or sponsors collaborate on diagnostic test development; and
- any final guidance should clarify that therapeutic product labeling should continue to specify use of an FDA approved or cleared companion diagnostic device, rather than a particular manufacturer’s companion diagnostic device, and that companion diagnostic class labeling will not affect the clinical studies section of therapeutic product labeling.

In its [comments](https://www.regulations.gov/document?D=FDA-2018-D-3380-0013&ref=fdaweb.com), AdvaMed says it has long supported flexibility in labeling with respect to companion diagnostics and supports FDA’s draft guidance outline of considerations for the development and labeling of such devices to support the indicated uses of multiple drug or biologic oncology products, when appropriate. It asks that the guidance discuss any changes in FDA expectations for a new companion diagnostic device under development and also provide more details and clarification on what constitutes an appropriate level of evidence to support a broader claim.