MDIC is the only public-private partnership (PPP) developed to work with government and industry stakeholders in an effort to advance solutions that promote patient access to innovative medical technologies.

Latest News:

Project Focused on Using RWE to Convert IVD EUAs to 510(k) Underway

In 2020, MDIC’s Clinical Diagnostics program launched the ‘Open Hand’ project, a process to pave a path for using IVD Real-World Evidence in regulatory submissions. The goals of this project are to provide a transparent process to evaluate new technology and methods; capture “the how” to share with broader community while staying in the pre-competitive space […]

MDIC releases playbook of best practices for shifting organizations to a Culture Of Quality

MDIC has released its Leadership Engagement Playbook of best practices and tools to help leaders move their companies from a culture of compliance to a culture of quality. Created through the Case for Quality Collaborative Community (CfQcc), the playbook aims to help organizations tailor their approach to quality by providing resources to determine which concepts, […]

MDIC seeks candidates to provide feedback on COVID-19 Patient Discussion Tool

MDIC is developing an updated COVID-19 Patient Discussion Tool to help patients better understand the implications of delaying or forgoing medical treatment during the ongoing pandemic. The aim of the tool is not to guide the patient towards a specific conclusion, but to assist them in gathering information potentially important to making a final decision. In […]

MDIC releases draft framework on External Evidence Methods for public comment

MDIC is seeking public comment on its framework External Evidence Methods: Statistical Methods for Leveraging External Data in Regulatory Decision-Making.  This framework intended to help stakeholders navigate their way through the nuts and bolts of leveraging external data. It catalogs different sources of external data and traditional and novel statistical methods applicable to the design and […]

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