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# MDIC External Evidence Framework Open for Comments
- URL: https://www.fdaweb.com/mdic-external-evidence-framework-open-for-comments/
- Published: 2021-01-21T12:00:00.000Z
- Updated: 2026-09-14T16:43:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148494

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](http://www2.mdic.org/webmail/673283/489470338/e66156fca8dbb32f862f5dffcc52c9bba0a6f9df3860947e8209175b76d2cb47?ref=fdaweb.com) says the [document](https://mdic.org/news-events/publiccomments/?ref=fdaweb.com) 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](https://mdic.org/event/eem-framework-webinar/?ref=fdaweb.com) on the framework and how to submit comments.