For some medical devices and/or therapies, the use of in vitro companion tests or devices (aka IVDs) is an essential part of the product. Now the FDA is providing you with information on how it expects to be informed of such devices. This new FDA Guidance Document, “In Vitro Companion Diagnostic Devices,” provides you with general information on definitions, rationale for oversight, and other policy information you’ll need to know.
Why now? The use of increasingly personalized therapies is dependent on identification of patient populations that will either be helped or harmed by such targeted treatments. (The Guidance Document gives HER2 breast cancer screening as an example.) An additional use of such products or processes is in monitoring the effectiveness of treatment as well.
What’s so special? These diagnostic companion devices may receive special treatment, since they can go through the FDA approval process both in tandem with the therapeutic product itself or alone, both prior to and post approval of the therapeutic product they’re used with. Additionally, the diagnostic companion may have originally been intended for another use and only now is being re-purposed.
The FDA will use a risk-based approach to determine the regulatory pathway for IVD companion diagnostic devices. So you’ll need to apply for FDA approval and go through the same processes used for other devices. And yes, there will be labeling and other requirements as well. This guidance document gives you an overview of what to expect, how to proceed, and what to prepare for.
The FDA provides the public with a number of these guidance documents and Document Center Inc. tracks them for you. For example, a draft of this document was released in 2011. For our customers who use this draft, notification of the new edition has already taken place. This is an invaluable service, since there are few ways to monitor these FDA publications.
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