Surrogate Samples Harmonized Education
MDICx: Surrogate Sampels Harmonized Education – from the MDIC Clinical Diagnostics Surrogate Samples Working Group
June 27, 2019, 12 p.m. ET/ 11 a.m. CT/ 9 a.m. PT
Surrogate samples, when properly used, can not only decrease the time needed for analytical testing, but also reduce the costs and time of sample collection for development and regulatory submission. But the lack of commonly agreed to terminology and a defined experimental framework for surrogate use reduces the predictability and efficiency of IVD development, translating into higher costs and reduced patient access to new and innovative medical devices.
The framework — created via a 22-month collaborative process between MDIC, FDA CDRH, AdvaMed, BD, Abbott, Hologic, Sysmex, Roche, and BARDA — aims to establish a foundation for the use of surrogate samples to support IVD product development and the regulatory process. The framework may be found here.
Harmonized educational materials were created for IVD test developers and FDA CDRH reviewers to facilitate a more predictable pathway for submissions.
Key topics include:
- MDIC Public-Private Partnership
- Overview of the Surrogate Samples project
- Update on the status of the CLSI EP:39 Surrogate Samples Framework
- Overview on using the framework and selected case studies.
- Timothy Stenzel, MD, PhD | Director, OHT7: Office of In Vitro Diagnostic and Radiological Health | Office of Product Evaluation and Quality | CDRH | FDA
- April Veoukas, JD | Director, Regulatory Affairs, Strategic Regulatory Affairs, Abbott Quality & Regulatory
- Marina Kondratovich, PhD | Associate Director for Clinical Studies, OHT7: Office of In Vitro Diagnostic and Radiological Health | Office of Product Evaluation and Quality | CDRH | FDA