Devices

MDIC Device External Evidence Framework

The Medical Device Innovation Consortium (MDIC) has published its MDIC External Evidence Methods Framework, which was developed by experts from FDA, industry, and academia. MDIC says the framework is intended to help stakeholders navigate their way through the process of leveraging external data by harnessing the power of statistics.

“The 21^st Century Cures Act, as well as the learnings from the Covid-19 public health emergency, underscored the need to expand the role of relevant external data in the total product lifecycle of medical devices,” MDIC says.

The framework was informed by several public forums and a survey of medical device manufacturers and identifies:

sources of external data;
traditional and novel statistical methods for incorporating external evidence;
potential uses of external data in the medical device regulatory process; and
examples to illustrate the application of statistical methodology where external data have been leveraged.

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