GUIDANCE DOCUMENT
Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology Draft Guidance for Industry and Food and Drug Administration Staff December 2021
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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All written comments should be identified with this document's docket number: FDA-2021-D-0996
- Docket Number:
- FDA-2021-D-0996
- Issued by:
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Guidance Issuing OfficeCenter for Devices and Radiological Health
This draft guidance document provides the FDA's recommendations on design considerations, non-clinical testing, animal studies, and labeling to support premarket submissions for medical devices with physiologic closed-loop control technology. This guidance applies to the design and testing of a device incorporating physiologic closed-loop control technology. The design and testing will depend on a variety of factors, including, but not limited to, the energy or article being delivered, environment of use, level of automation, training of the user population, patient population, properties of the physiologic-measuring sensor, method of control algorithm design, and properties of the delivery system. The recommendations are intended to promote consistency and facilitate efficient review of medical devices with physiologic closed-loop control technology submissions.