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FDA has released a Draft Guideline Document on evaluating Physiologic closed loop Control Devices

The CDRH (Center for Devices and Radiological Health) of the US FDA (Food and Drug Administration) published draft advice on developing medical devices using PCLC (Physiologic closed-loop control) technology in late December to assure their safe and effective usage. Patient and device-related risks, as well as use-related hazards, should be carefully considered in submissions.

These devices have a sensor that detects a Physiologic variable from the patient, a controller/control algorithm, and an actuator that provides or removes energy or an object from the patient, such as a medicine.The FDA describes these devices as “emerging uses for the critical and emergency care situations,” since they allow automated treatment administration to patients for fluid resuscitation, breathing, and anesthesia. Hemodynamic stability controllers and mechanical ventilation and oxygenation controllers are examples of PCLC devices.

However, according to the FDA’s draft guideline release, “introducing automation and minimizing physician engagement might incur new types of dangers that may render the medical device dangerous if not appropriately developed or reviewed.”The guideline includes patient-related risks, device-related hazards, system safety features, the user interface, non-clinical testing considerations, human factors testing, and labeling as well as design and risk management concerns for these devices.

According to the proposed advice, “design inputs for a device utilizing PCLC technology should evaluate the hazards associated with the entire device, not just the PCLC functionalities.” “A PCLC device should be designed to be safe to use in the patient demographic, clinical environment, and clinical workflow in which it will be utilized.”FDA says risk management strategies should address how uncertainties in design and suggested workflow might impact the functioning of a PCLC device to reduce any device-related risks.

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