The FDA’s draft guidance for predetermined change control plans (PCCPs) is just that, a draft guidance, but that has not stopped the agency from incorporating the underlying concepts into existing guidances. An example of this is the September 2023 guidance for antimicrobial susceptibility test (AST) system for breakpoints in device labeling, a document that represents a jarring update to the legacy version published in 2009.

Neuroimmune modulation using vagus nerve stimulation (VNS) reduced Crohn’s disease symptoms and improved patient quality of life, a study published in the Journal of Crohn’s and Colitis found. The research by Setpoint Medical Corp. could provide a better option for patients with the autoimmune disorder than biologics, which often fail to work over time and can cause significant adverse effects.