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Regulatory considerations for companion diagnostic devices
Eunice Y Lee1, Hsin-Chieh Jennifer Shen
1Division of Molecular Genetics & Pathology, Office of In Vitro Diagnostics & Radiological Health, Center for Devices & Radiological Health, US FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
Biomarkers in Medicine
|January 22, 2015
Summary
Companion diagnostic devices are crucial for targeted cancer therapies. This study outlines US regulatory strategies for co-developing these diagnostics with drugs, considering future challenges.
Area of Science:
- Biomedical Engineering
- Oncology
- Regulatory Science
Background:
- Companion diagnostics (CDx) are essential for targeted therapies, especially in oncology.
- Co-development of CDx and therapeutics ensures product safety and efficacy.
- The regulatory landscape for CDx has evolved due to their critical role in treatment selection.
Purpose of the Study:
- To describe the current US regulatory model for companion diagnostics.
- To outline strategies for successful co-development programs from a device perspective.
- To discuss potential future challenges to the regulatory model.
Main Methods:
- Review of the current US regulatory framework for companion diagnostics.
- Analysis of key strategies for companion diagnostic device co-development.
- Discussion of technological and clinical management trends impacting regulation.
Main Results:
- The US employs a specific regulatory model for companion diagnostics.
- Successful co-development requires strategic planning from the device viewpoint.
- Technological advancements and evolving clinical practices may necessitate regulatory adaptation.
Conclusions:
- Understanding the current US regulatory model is key for companion diagnostic development.
- Proactive strategies are vital for successful co-development programs.
- The future regulatory framework must accommodate emerging technologies and clinical changes.
Keywords:
assaybiomarkercodevelopmentin vitro companion diagnosticmedical devicepersonalized medicineprecision medicineregulationMore Related Videos
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