Medical Device Innovation Consortium Seeks Public Comment on In Vitro Diagnostics Real-World Evidence Framework

ARLINGTON, Va.–()–The Medical Device Innovation Consortium (MDIC) is seeking public comment on its draft framework, Real-World Clinical Evidence Generation: Advancing Regulatory Science and Patient Access for In Vitro Diagnostics (IVDs). Created through a collaborative process between MDIC, FDA’s Center for Devices and Radiological Health (CDRH), and industry partners, the framework aims to help industry and FDA consider when and how real-world data might be incorporated into product development and regulatory decision-making in support of clearance or approvals of IVDs. Also, the framework outlines considerations for appropriate designs and statistical methods for generating real-world evidence (RWE) for regulatory submissions.

The IVD RWE Framework builds off CDRH’s guidance on RWE to support regulatory decision-making for medical devices. While CDRH has used RWE in regulatory decision-making about medical devices for years, the center and industry have less experience with RWE across the range of IVD devices, especially in pre-market decision-making. The framework highlights issues relevant to clinically validating IVD real-world data for pre-market and post-market decision-making.

“Real-world data can expedite innovation by generating clinical evidence and facilitating epidemiological surveillance, as well as supporting regulatory decision-making,” said Carolyn Hiller, MBA, clinical diagnostics program director for MDIC. “In combatting the COVID-19 pandemic, epidemiological surveillance using Electronic Health Records, Laboratory Information Systems, industry databases, and other public and private sources can identify hot spots and effective treatments.”

Industry partners involved in creating the IVD RWE Framework include Abbott Diagnostics, Genomic Health, Hologic, IBM Watson, ICON plc, Johnson & Johnson, Roche Diagnostics, Sysmex America, and Thermo Fisher Scientific. Individual subject matter experts in regulatory science and policy, epidemiology, and biostatistics also participated in the process.

Public Comment Period Now Open

The public comment period for the IVD RWE Framework remains open through June 15, 2020. Additionally, MDIC is hosting a webinar to answer questions about the framework and public comment process on May 28, 2020. A recording of the webinar will be available afterward.

About the Medical Device Innovation Consortium

Founded in 2012, the Medical Device Innovation Consortium (MDIC) is the first public-private partnership created with the sole objective of advancing medical device regulatory science throughout the total product life cycle. MDIC’s mission is to promote public health through science and technology and to enhance trust and confidence among stakeholders. MDIC works in the pre-competitive space to facilitate the development of methods, tools, and approaches that enhance understanding and improve evaluation of product safety, quality, and effectiveness. Its initiatives aim to improve product safety and patient access to cutting-edge medical technology while reducing cost and time to market. For more information, visit


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