FDA Issues Draft Guidance on Devices with Physiologic Closed-Loop Control Technology

Today, the U.S. Food and Drug Administration (FDA) issued this draft guidance: Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology.

Physiologic closed-loop control (PCLC) technology can enable automation in a variety of medical device types, including automated anesthesia delivery systems, mechanical ventilation, hemodynamic stability systems, neurostimulators, pacemakers, infusion pumps, ventilators, and extracorporeal systems (such as dialysis delivery systems).

Read the Draft Guidance

Facts about the draft guidance

This draft guidance:

• Describes physiologic closed-loop controlled (PCLC) devices.
• Highlights technical considerations for the development of medical devices employing PCLC technology to ensure safe and effective use.
• Provides recommendations for the content of premarket submissions.
• Incorporates feedback received during the public workshop in 2015 and from numerous interactions with companies designing PCLC medical devices.

Note: This guidance is not for implementation at this time.

Submit comments on this draft guidance

This draft guidance will be open for public comments for 60 days at www.Regulations.gov under docket number FDA-2021-D-0996.

Questions?

If you have questions about this draft guidance, contact the Division of Industry and Consumer Education.