The Medical Device Innovation Consortium (MDIC) finished developing its Real-World Evidence (RWE) Framework for regulatory decision-making for in vitro diagnostics (IVDs) through a collaborative process between MDIC, FDA CDRH, and other industry partners. The framework aims to help FDA and industry incorporate real-world data into product development and regulatory decision-making in support of clearance or approvals of IVDs. It also aids in selection of appropriate designs and statistical methods for generating real-world data for regulatory submissions. “We hope the framework will stir the conversations and actions needed to facilitate greater use of real-world evidence in regulatory decision-making, and ultimately, accelerate patient and healthcare provider access to innovative IVDs that are safe and effective,” said Danelle Miller, JD, Chair of the MDIC IVD Real-World Evidence Working Group and Vice President of Global Regulatory Policy & Intelligence at Roche Diagnostics.
MDIC has further plans to apply the framework to COVID-19 related RWE projects in partnership with FDA CDRH. “As we work to control the COVID-19 pandemic and plan for future healthcare challenges, the use of RWE can expedite the development of IVDs. This will allow us to leverage the power of diagnostic testing for patient management and public health,” said Pamela Goldberg, MBA, President and CEO of MDIC. Read more about the framework here.
(Source: Taylor Jackson, Business Wire, August 24, 2020)