February 23, 2022
ASA Provides Recommendations to FDA on Physiologic Closed-Loop Control Draft Guidance
This week, ASA submitted a comment letter to the Food and Drug Administration (FDA) on the agency’s “Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology” draft guidance. The draft guidance provides recommendations on the safe design and marketing of physiologic closed-loop control (PCLC) devices, which form systems that automatically adjust physiologic variables for a patient, such as the administration of a drug, using feedback from a sensor that monitors vital signs or other physiologic variables.
ASA provided specific comments to sharpen and clarify the FDA’s recommendations, including a number of suggested categorizations for PCLC devices by factors like the robustness of the sensors and the observability of the system to help differentiate risk levels and appropriate safety precautions. ASA stated later in the letter that anesthesia-based PCLC devices in the operating room would be a particularly safe environment for the technology due to the continuous presence of an anesthesia provider. ASA also voiced its support of end-tidal (ET) anesthetic agent controllers on anesthesia machines. ASA noted that the use of ET agent control devices could play a significant role in reducing anesthetic waste and environmental pollution.
For more information, contact the ASA Department of Quality and Regulatory Affairs (QRA) at [email protected].
To read ASA’s comment letter, click here.