May 14, 2020

MDIC is seeking public comment on its framework Real-World Clinical Evidence Generation: Advancing Regulatory Science and Patient Access for In Vitro Diagnostics (IVDs)

This framework was established following the release of the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Guidance, “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Guidance for Industry and Food and Drug Administration Staff,”  (RWE Guidance) which focuses on the use and potential value of RWE to support regulatory decision-making for medical devices. In the RWE Guidance, FDA notes that such evidence may be created from real-world data (RWD) through the use of appropriate methods and recommends that parties wishing to use RWE contact the FDA regarding the submissions using RWE. The Framework builds off of this by providing additional contextual information to help industry and FDA consider when and how RWD, appropriate designs, and statistical methods including modeling to generate RWE might be incorporated into product development and regulatory decision-making, particularly in support of clearance or approvals of IVDs. Although RWE has been used by FDA for years in many different contexts across the Total Product Life Cycle (TPLC), there is less experience with RWE across the range of IVD devices, especially in pre-market regulatory decision-making. This framework focuses on issues pertinent to clinical validation of RWD in pre-market and post-market regulatory decision-making of IVD devices.

View the framework here. Read the full press release here.

The public comment period is open from May 14 – June 15, 2020.

An informational webinar on the Framework will be held on Thursday, May 28.

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