FDA updates physiologic closed-loop control final guidance with industry feedback

The US Food and Drug Administration (FDA) has finalized guidance on physiologic closed-loop control (PCLC) technologies that includes several updates requested by medical device manufacturers. More specifically, it includes additional examples of devices that the agency categorizes as PCLCs and risks that sponsors should consider.

In December 2021, FDA published draft guidance on technical considerations that sponsors of PCLCs should consider when designing their products. It focused on the potential risks associated with PCLCs and how they can be mitigated (RELATED: FDA issues draft guidance on assessing physiologic closed-loop control devices, Regulatory Focus 6 January 2022).

“Not all considerations in this guidance will be applicable to every PCLC device given the variety of device types that can incorporate PCLC technology,” FDA wrote in the final guidance. “Manufacturers should determine and justify in premarket submissions which considerations are appropriate for their device based on the technology being used and the intended use of the device.”
(current guidance?_

While FDA detailed what it considers a PCLC, stakeholders such as Becton, Dickinson, and Company (BD) asked for more clarity on the scope of the guidance. More specifically, the medtech manufacturer asked the agency to expand the examples of PCLCs to include hypo- and hyperthermia systems used to adjust patient body temperature for certain types of treatments and short-term drug delivery systems (RELATED: Device companies urge FDA to refine guidance on PCLC devices, Regulatory Focus 1 March 2022).

In the draft guidance, FDA listed automated anesthesia delivery systems, mechanical ventilation, and hemodynamic stability systems as examples of PCLCs. In the final guidance, the agency goes further by not only including hypo- and hyperthermia systems in its examples of PCLCs, but also including its rationale for why such devices are within the scope of the guidance.

“Although elements of this guidance may be applicable to active implantable devices with PCLC technology, including neurostimulators and pacemakers, additional considerations outside the scope of this guidance may also need to be addressed (e.g., related to the long-term use of the PCLC function),” FDA wrote. “In some cases, there may be device-specific guidances that should also be utilized, and this guidance is not intended to supersede other device-specific guidances.”

The final guidance also adds details on when PCLCs may be used in integrated clinical environments. Such settings, according to the agency, use various interoperable medical devices to integrate patient care by creating a comprehensive medical system. FDA lists the types of hazardous conditions sponsors should consider for PCLCs used in integrated clinical environments and potential issues that may arise when trying to integrate all the devices used to create the medical system.

When taking into account risk management considerations of PCLC devices, much of the agency’s recommendations remain the same. However, the final guidance advises sponsors of PCLC devices that are comprised of interoperable medical devices to take into consideration hazards listed in the American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI)/Underwriters Laboratories, Inc. (UL) 2800-1: Standard for Safety for Medical Device Interoperability.

In comments on the draft guidance, GE and Medtronic Respiratory Interventions recommended FDA include additional examples of sensor performance risks. The agency had originally listed eight factors to consider when evaluating risks related to inadequate sensor performance of PCLC devices. GE asked FDA to include sensor performance risk due to calibration drift over time as an additional risk, and Medtronic asked the agency to include sensor failure as a risk.

The agency added both examples in the final guidance as well as issues such as sensor uncertainty and electronic data interference. “For some PCLC devices, it may be necessary to monitor sensor performance so that the system can detect faults related to the sensor or identify calibration drift over time and revert to back up sensors or fallback modes as appropriate,” FDA wrote.

Final guidance

FDA updates physiologic closed-loop control final guidance with industry feedback

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