The Patient Monitoring and Control Program in the FDA’s Center for Devices and Radiological Health (CDRH) conducts regulatory science research to help ensure access to innovative patient monitoring and control devices that are safe and effective. This is one of 20 research programs in CDRH’s Office of Science and Engineering Laboratories (OSEL).
Patient Monitoring and Control Devices
The incorporation of artificial intelligence, automation, and interoperability in medical devices enables new patient monitoring and control capabilities. These capabilities can enhance patient safety in settings from critical care to wearable health care. Medical devices with these functions range from Software as a Medical Device (SaMD) applications to integrated systems of multiple medical devices.
These technologies have a number of potential benefits to patients, such as minimizing false alarms, providing precise and informative detection of patient changes, automatically stopping therapy to prevent dangerous scenarios, or automatically adjusting therapy to deliver only what is necessary to treat a patient. Nevertheless, the different clinical applications and types of medical devices can lead to inconsistency in requirements and testing caused in part by a lack of established nonclinical test methods. This inconsistency causes increased testing costs and delays in the regulatory process.
Regulatory Science Gaps and Challenges
Major regulatory science gaps and challenges that drive the Patient Monitoring and Control Program are:
- Lack of clear guidelines on testing with patient monitoring datasets that limits the utility of this type of least-burdensome testing and often results in significant reanalysis efforts or collection of new data.
- Limited availability of test methods to study the consistency and repeatability of physiologic waveform-based biomarkers considering device and patient variability factors.
- Lack of established computational modeling and simulation approaches for evaluating physiologic closed-loop control systems.
- Limited availability of test methods and quality of information in interface specifications for interoperable systems.
- Lack of evaluation frameworks over the total product life cycle for continuous learning and personalized patient monitoring algorithms.
The Patient Monitoring and Control Program is intended to fill these knowledge gaps by fostering predictable and transparent device assessment, development, and innovation and by making the FDA better prepared for addressing devices issues at both the premarket and postmarket stages in the medical device lifecycle.
Patient Monitoring and Control Program Activities
The Patient Monitoring and Control Program focuses on regulatory science research in these areas:
- Study designs and benchmarking approaches for patient monitoring algorithm testing.
- Tools to aid in the assessment of physiologic waveform analysis algorithms.
- Computational modeling and simulation methods for evaluating physiologic closed-loop control devices.
- Methods to identify unsafe situations when multiple physiologic closed-loop controlled devices are applied to the same patient.
- Test methods and guidelines for developing interface specifications for devices used in interoperable environments.
- Evaluation methods over the total product life cycle for continuous learning applications in integrated clinical environments.
For more information, email OSEL_monitoringcontrol@fda.hhs.gov