The National Heart, Lung, and Blood Institute (NHLBI), in collaboration with the U.S. Food and Drug Administration's Center for Devices and Radiological Health (FDA/CDRH), will convene a virtual workshop focused on regulatory science approaches to accelerate cardiovascular device innovation. The workshop will explore key opportunities, evidence needs, technology challenges, and regulatory considerations relevant to academic, industry, clinical, and regulatory communities.

Consensus standards, regulatory science tools, and validated methods can improve predictability, clarify regulatory expectations, facilitate premarket review, and support market access. However, developing and adopting these resources can be time consuming, particularly for emerging technologies and novel device areas, placing added burden on early developers and innovators.

Regulatory science tools and approaches can help reduce reliance on ad hoc testing methods and support more efficient evidence generation and assessment. Accordingly, the workshop will examine how shared methodologies, validation practices, and regulatory review approaches can reduce uncertainty and improve cardiovascular device development and evaluation.

Overarching Workshop Goals

• Highlight regulatory science resources and approaches for cardiovascular device evaluation.
• Foster cross-sector discussion to strengthen evidence, improve predictability, and support safe, effective cardiovascular technologies.
• Identify key gaps and challenges affecting regulatory readiness and innovation.

Workshop Focus Areas

• Artificial Intelligence, Software as a Medical Device, and Software-Enabled Regulatory Evaluation:
  Artificial intelligence-enabled devices, Software as a Medical Device, validation, predetermined change control plans, bias assessment, performance monitoring, and lifecycle considerations.
• In Silico Modeling, In Vitro Testing, and New Approach Methodologies for Cardiovascular Devices:
  Computational modeling, digital twins, new approach methodologies, verification, validation, and uncertainty quantification, test-method validation, standards, and hemocompatibility/biocompatibility assessment.
• Cardiovascular Diagnostics, Wearables, and Connected Monitoring:
  Digital biomarkers, wearable sensors, point-of-care diagnostics, remote monitoring, interoperability, and clinical validation.
• Innovative Cardiovascular Treatment Devices:
  Heart valves, mechanical circulatory support, heart-failure devices, vascular and interventional technologies, safety/performance evaluation, and adoption challenges.
• Evidence Generation, Real-World Data, and Lifecycle Evaluation:
  Real-world data and real-world evidence, registries, fit-for-purpose data, validation datasets, post market monitoring, and regulatory use of evidence.
• Early Clinical Translation and Trial Innovation:
  Early feasibility and first-in-human studies, Investigational Device Exemption planning, endpoints, patient selection, trial design, and early regulatory engagement.

Session Structure:

Each session will bring together FDA/Government, industry, clinical, and academic perspectives to discuss regulatory science resources, evidence and validation needs, review considerations, development challenges, implementation barriers, and research opportunities.

Sessions will include three 15-minute talks followed by a 25-minute moderated panel discussion focused on key gaps, actionable opportunities, and potential next steps to strengthen evidence, improve predictability, and support safe and effective cardiovascular device innovation.

Event Dates\Times:

November 12, 2026: 9:00 a.m. – 5:20 p.m. EDT
November 13, 2026: 9:00 a.m. – 12:00 p.m. EDT

Virtual Details:

A link to join the virtual workshop will be sent to you closer to the workshop. Registration for the workshop is free but required in order to attend.

Contact:

For questions or to request reasonable accommodations to participate in this event, please email Rashaad Houston at rashaad.houston@nih.gov.