Devices

MDIC External Evidence Framework Open for Comments

David McFarland

— 1 min read
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The Medical Device Innovation Consortium (MDIC), which includes FDA as a member, will receive public comments until 2/22 on its External Evidence Methods Framework. An MDIC statement says the document is intended to help stakeholders navigate their way through the nuts and bolts of leveraging external data. Specifically, the statement says, the framework aims to provide stakeholders with support needed by: 

  •          cataloging different sources of external data;
  •          cataloging statistical methods that can be considered to leverage external data;
  •          considering uses of external data, when appropriate, for premarket regulatory decision-making for medical devices; and
  •          providing examples to illustrate the application of various statistical methods where external data have been leveraged.

MDIC will hold a 2/10 informational Webinar on the framework and how to submit comments.

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