FDA Releases Case for Quality Pilot Program Report, Seeks Feedback

MDIC, on behalf of the U.S. Food and Drug Administration (FDA), is seeking public comments on a new report from FDA’s Case for Quality program, Voluntary Manufacturing and Product Quality Pilot Program Results. FDA engaged with MDIC in 2014 to develop an ongoing forum to bring stakeholders across the medical device ecosystem together to collaborate on […]

NESTcc Named One of the First Collaborative Communities with FDA Participation

The U.S. Food and Drug Administration (FDA) today announced that the National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), has achieved recognition as one of the first collaborative communities with participation by the FDA’s Center for Devices and Radiological Health (CDRH).  CDRH identified participation in […]

MDIC seeks participation in new digital pathology and AI collaborative effort

MDIC, FDA and Digital Pathology Association (DPA) are working to prioritize the areas of Digital Pathology and AI where MDIC can bring industry, users, government, insurance companies, and patients together to collaboratively work on several new projects. This alliance aims to work on: Temporary framework to synergize and tackle larger scale projects Harmonizing & standardizing […]

MDIC releases first of three resources that will be part of its Framework for Patient Input in Medical Device Clinical Trials

MDIC is seeking public comments on its Best Practices for Communicating Benefit, Risk and Uncertainty white paper in support of the Framework for Patient Input in Medical Device Clinical Trials that is set to be complete next year. MDIC’s Science of Patient Input Steering Committee has worked to understand the best methods to assess patient […]

MDIC Releases IVD Clinical Evidence Framework

MDIC’s Clinical Diagnostics Program today released the Framework for Developing Clinical Evidence for Regulatory and Coverage Assessments in In Vitro Diagnostics. This Framework is intended to help test sponsors make decisions on how to develop credible evidence of analytical and clinical validity and clinical utility. It is a product of MDIC’s IVD Clinical Evidence Working […]

CVRx President and CEO Nadim Yared Named Chairman of the MDIC Board of Directors

MDIC announced today that CVRx’s President and CEO Nadim Yared has been named chairman of the MDIC Board of Directors and Executive Committee for a two-year term. Yared has served on the MDIC Board of Directors since 2013. He will succeed Abiomed President and CEO, Michael Minogue who will remain on the Board. Read the […]

MDIC Releases 2018 Annual Report

MDIC is excited to announce the release of our first annual report and share the impact of our work during the 2018 year. This report not only helps quantify and demonstrate the impact we’ve had but also helps us identify opportunities for growth and improvement. Some of the key highlights from the Annual Report include […]

NESTcc Announces 12 New Real-World Evidence Test Cases

Today, NESTcc announced 12 new Real-World Evidence (RWE) Test-Cases.  These projects will answer questions of importance to the medical device ecosystem through collaborations between NESTcc Network Collaborators and submitting organizations, including health systems, government organizations, non-profit patient organizations, and medical device manufacturers.  NESTcc’s Test-Case portfolio now includes 20 projects that span the Total Project Life […]

MDIC Seeks Comments on Draft List of Prioritized Tumor Suppressors

MDIC’s Clinical Diagnostics Cancer Genomic Somatic Reference Samples working group seeks public comments on the draft list of prioritized tumor suppressors. The goal of the initiative is to develop reference samples that can be made available to the public to improve the accuracy, reliability and transparency of Next-Generation-Sequencing (NGS) based oncology tests. In addition, the […]