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New RWE Framework Aims To Get IVDs To Market Faster, Surveil COVID-19 Tests

Three years after the US FDA released a guidance to use real-world evidence in premarket applications, the stakeholder group MDIC has unveiled a framework for how IVD RWE can be captured and used by sponsors for premarket applications.

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Influential medtech stakeholder group the Medical Device Innovation Consortium has published a framework for how companies can collect real-world evidence (RWE) data and use the findings to support premarket applications for in vitro diagnostics. The MDIC says its framework can also be used to surveil COVID-19 IVDs that have quickly sprung onto the market through emergency use authorizations (EUAs) from the US Food and Drug Administration, using less premarket data due to the ongoing crisis.

The MDIC has been at the forefront of RWE regulations. Three years ago it helped the FDA write and finalize a guidance titled “Use of Real-World Evidence to Support Regulatory...

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