MDIC Releases Framework on External Evidence Methods for Medical Devices

The framework aims to help stakeholders use new, innovative and existing statistical methods for the fusion of evidence from data external to a clinical study.

ARLINGTON, Virginia, April 28, 2022–(BUSINESS WIRE)–The Medical Devices Innovation Consortium (CIDM), today announced the publication of the MDIC External Evidence Methods (EEM) Framework. This framework, developed by subject matter experts from industry, academia, and the U.S. Food and Drug Administration (FDA), is a document intended to help stakeholders navigate the operating process. external data by harnessing the power of statistics. The 21st Century Cures Act, along with lessons learned from the COVID-19 public health emergency, has underscored the need to expand the role of relevant external data in the total lifecycle of medical devices.

“This framework highlights the potential for incorporating data external to a clinical trial into the analysis of a medical device. The FDA will continue to build on sound science to help accelerate patient access to innovations that advance public health while ensuring the safety and effectiveness of medical devices,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health.

Informed by a number of public forums and a survey of medical device manufacturers, this framework identifies:

1. Various external data sources

2. Traditional and new statistical methods to incorporate external evidence

3. Potential uses of external data in the medical device regulatory process

4. Examples to illustrate the application of the statistical methodology when using external data

“The concept of working with various external sources of data to augment clinical trials is not new, and there are many established statistical methods for doing this. But there is still room for the development of additional methods or l “application of (existing) unusual approaches. Here, the MDIC External Evidence Methods framework document developed in collaboration between regulators, academia and industry provides a useful reference of past successes and future possibilities,” said Ted Lystig , Senior Vice President, Chief Analytics Officer at BridgeBio and former Global Director of Biostatistics at Medtronic, who was the lead industry subject matter expert at the time of the development of this document.

“The release of the EEM Framework marks a key milestone for MDIC and reflects our commitment to advancing clinical studies by transforming available data into high-quality evidence,” said Pamela Goldberg, CEO of MDIC. “We are excited to share this important work to help inform clinical and regulatory decision-making and support health outcomes for people using medical devices. As a community, we will make progress when we can share (before the competition) lessons learned and make process improvements for using external information.”

The SEE framework is the newest addition to the MDIC Resource Directory that focuses on reliable, cost-effective real-world evidence (RWE) across the total medical product lifecycle, including the National Disaster Coordinating Center Evaluation System. health technology (NESTcc) Research Methods Framework and Data Quality Framework as good as Generating real-world clinical evidence: advancing regulatory science and patient access to the in vitro diagnostic (IVD) framework.

About the Medical Devices Innovation Consortium

Founded in 2012, the Medical Device Innovation Consortium (MDIC) is the first public-private partnership created for the sole purpose of advancing the regulatory science of medical devices throughout the product lifecycle. MDIC’s mission is to promote public health through science and technology and to build trust among stakeholders. MDIC works in the pre-competitive space to facilitate the development of methods, tools and approaches that improve the understanding and evaluation of product safety, quality and efficacy. Its initiatives improve product safety and patient access to advanced medical technologies while reducing costs and time to market. For more information, visit

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Gregory Bologna, AVP, Marketing and Communications, MDIC, [email protected]

Shirlene J. Manley