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In December 2021, FDA published draft guidance on technical considerations that sponsors of PCLCs should consider when designing their products. It focused on the potential risks associated with PCLCs and how they can be mitigated (RELATED: FDA issues draft guidance on assessing physiologic closed-loop control devices, Regulatory Focus 6 January 2022).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