The Medical Device Innovation Consortium (MDIC) said its regulatory framework for regulatory decision-making for in vitro diagnostics takes up a regulatory area that is less well developed than is the case with therapeutic medical devices. MDIC said it has launched an RWE test case applicable to the COVID-19 pandemic to evaluate the framework, which will include both serology antibody tests and molecular tests. A sub-project will link electronic lab data to electronic health records to allow surveillance and studies across institutions with an eye toward harmonizing data standards. This framework will be the subject of a Sept. 10 webcast.