The Cardiovascular Program in the FDA’s Center for Devices and Radiological Health (CDRH) conducts regulatory science research to help fulfill CDRH’s mission of continued patient access to innovative cardiovascular devices that are safe and effective. This is one of 20 research programs in CDRH’s Office of Science and Engineering Laboratories (OSEL).
Cardiovascular Medical Devices
Millions of patients have benefited from cardiac medical devices regulated by the FDA, such as catheters, stents, artificial heart valves, hemodialyzers, ventricular assist devices (VADs), endovascular grafts, and inferior vena cava (IVC) filters. The FDA also regulates a variety of devices that monitor and affect electrical activity including cardiac mapping systems, ablation catheters, pacemakers and defibrillators. In addition, the FDA evaluates biosafety of device materials to avoid potential cardiac and neural toxicity induced by direct contact of the device with the human body.
Although the FDA has made significant improvements in preclinical testing, standards, and guidance documents related to cardiac medical devices, evidence of adverse events related to these devices create an imperative need to address regulatory science research gaps that will continue to spur medical device safety and innovation, while ensuring that innovate cardiovascular devices are safe and effective before they reach patients.
Regulatory Science Gaps and Challenges
Major regulatory science gaps and challenges that drive the Cardiovascular Program are:
- Lack of credible preclinical blood damage assessment methods for medical materials and devices to better predict clinical outcomes and enhance patient safety.
- Overreliance on clinical data to assess the hemodynamic performance of cardiovascular devices due to lack of credible preclinical test methods.
- Reported durability issues in cardiovascular implants regardless of currently available preclinical durability tests, standards, or guidance documents.
- Lack of validated tools to predict clinical translation of novel cardiac medical devices in development, which hinders an efficient regulatory review process.
- Lack of human physiology-based computational and in vitro test methods to assess safety and effectiveness of cardiac medical devices.
The Cardiovascular Program is intended to fill these knowledge gaps by fostering the use of in vitro, in vivo, and in silico models to develop medical device evaluation tools and address current gaps in regulatory knowledge.
Cardiovascular Program Activities
The Cardiovascular Program focuses on regulatory science research in these areas:
- Hemocompatibility: In vitro and in silico based pre-clinical blood damage assessment tests, for hemolysis and thrombosis.
- Hemodynamics: Non-clinical test methods to assess device-patient interactions under simulated pathophysiological conditions
- Device Durability: Mechanical fatigue, corrosion, and mechanical assisted-material degradation of cardiovascular devices.
- Electrophysiology: In vitro and in silico cardiac electrophysiology device safety and effectiveness assessment methods.
For more information, email contact: OSEL_cardiovascular@fda.hhs.gov