IVDs and FDA Marketing Authorizations: A General Overview of FDA Approval Process of an IVD Companion Diagnostic Device in Oncology
In vitro diagnostic devices play an important part in the field of clinical oncology by identifying patients eligible for treatment with specific targeted therapeutic products. This chapter briefly discusses the risk-based classification of in vitro diagnostic devices and the FDA regulatory review of these devices. In vitro companion diagnostic devices and the role they play in oncology clinical trials and critical elements such as the device analytical and clinical performance are also discussed. An example of a companion diagnostic device approval process is also provided.
KeywordsRisk-based classification Companion diagnostic devices Analytical performance Clinical performance Regulatory review Modular PMA
- 1.US FDA: Code of Federal Regulations Title 21 §809.3(a).Google Scholar
- 2.US FDA: Code of Federal Regulations Title 21 §860.7(d)(1).Google Scholar
- 3.US FDA: Code of Federal Regulations Title 21 §860.7(e)(1).Google Scholar
- 4.US FDA. General controls for medical devices. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/GeneralandSpecialControls/ucm055910.htm.
- 5.US FDA. Evaluation of automatic class III designation (De Novo) Summaries. http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm232269.htm.
- 6.Requests for feedback on medical device submissions: the pre-submission program and meetings with food and drug administration staff. Guidance for industry and food and drug administration staff. Document issued on: February 18, 2014.Google Scholar
- 7.BEST (Biomarkers, Endpoints, and other Tools) resource. Food and Drug Administration (US) Silver Spring (MD) and National Institutes of Health (US) Bethesda (MD).Google Scholar
- 8.IOM (Institute of Medicine). Evaluation of biomarkers and surrogate endpoints in chronic disease. Washington, DC: The National Academies Press; 2010.Google Scholar
- 10.In Vitro Companion Diagnostic Devices. Guidance for industry and food and drug administration staff. Document issued on: August 6, 2014.Google Scholar
- 11.In Vitro Companion Diagnostic Devices. Guidance for industry and food and drug administration staff. August 6, 2014.Google Scholar
- 12.US FDA. List of cleared or approved companion diagnostic devices (In vitro and imaging tools) http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm301431.htm.
- 13.Reena P, Mansfield E, Carrington L, et al. In vitro companion diagnostic and anti-cancer drug co-development: regulatory perspectives. In: Tan D, Lynch HT, editors. Principles of molecular diagnostics and personalized Cancer medicine. Philadelphia: Lippincott Williams & Wilkins; 2013. p. 301–6.Google Scholar
- 14.PMA P140025: FDA summary of safety and effectiveness data. VENTANA ALK (D5F3) CDx Assay. http://www.accessdata.fda.gov/cdrh_docs/pdf14/P140025b.pdf.
- 15.PMA P140023: FDA summary of safety and effectiveness data. cobas® KRAS Mutation Test. http://www.accessdata.fda.gov/cdrh_docs/pdf14/P140023b.pdf.
- 16.PMA P150025: FDA summary of safety and effectiveness data. PD-L1 IHC 28-8 pharmDx (P150025). http://www.accessdata.fda.gov/cdrh_docs/pdf15/p150025b.pdf.
- 17.US FDA. Public workshop–next generation sequencing-based oncology panels, February 25, 2016. http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm480046.htm.
- 18.PMA P150013: FDA summary of safety and effectiveness data. PD-L1 IHC 22C3 pharmDx http://www.accessdata.fda.gov/cdrh_docs/pdf15/P150013B.pdf.
- 19.US FDA. Approved drugs. Pembrolizumab (KEYTRUDA) Checkpoint inhibitor. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm465650.htm.