Dive Brief:

• The Medical Device Innovation Consortium (MDIC), a collaboration between FDA and medtech manufacturers, on Monday published a roadmap for incorporating real-world evidence into in vitro diagnostic test development and regulatory authorization.
• Release of the framework comes as the coronavirus pandemic has accelerated use of newly generated data to update emergency use authorizations for IVDs. A flurry of molecular diagnostics and antibody tests have received EUAs since the pandemic began in a scramble to scale up supply.
• Companies involved in creating the Real-World Evidence Framework for IVDs include Abbott Diagnostics, Genomic Health, Hologic, IBM Watson, ICON, Johnson & Johnson, Roche Diagnostics, Sysmex America and Thermo Fisher Scientific.

Dive Insight:

The MDIC initiative builds on FDA's 2017 guidance document, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, with a focus on considerations for diagnostics. While work on the framework for incorporating RWE into regulatory decision-making for IVDs began several years ago, the COVID-19 pandemic has given the effort new urgency.

“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,” said MDIC CEO Pamela Goldberg in a statement.

FDA and industry have less experience with gathering and assessing real-world data for IVDs than with other devices, the consortium noted. The group said it sees an opportunity to develop best practices, tools and methodologies specifically for the acquisition and appraisal of relevant IVD data generated through routine clinical practice for use in supporting regulatory decisions.

“Understanding the accuracy of diagnostic tests requires data elements that are not as widely available as those in the therapeutic space and entails a different approach to data integration and analysis,” said Jeff Shuren, director of FDA's Center for Devices and Radiological Health, in a statement.

The new framework outlines considerations for appropriate designs and statistical methods for generating real-world evidence for regulatory submissions of IVD devices. It covers issues related to clinical validation of RWD in both premarket and postmarket regulatory decisions, and addresses data quality issues as well as approaches to data evaluation in a benefit/risk context.

As part of the effort, a targeted COVID-19 RWE project involving teams from industry, FDA, integrated healthcare systems and MDIC’s Systemic Harmonization and Interoperability Enhancement for Lab Data (SHIELD) program will look to link electronic laboratory data from coronavirus diagnostic tests to electronic health records to facilitate surveillance studies. Industry partners will work with the agency to design clinical study protocols for use of RWE in COVID-19 serology and molecular diagnostic tests and then conduct pilots with healthcare systems’ EHRs.