Technical Considerations for Physiologic Closed-Loop Control Devices – FDA.gov

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GUIDANCE DOCUMENT
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document’s docket number: FDA-2021-D-0996
This draft guidance document provides the FDA’s recommendations on design considerations, non-clinical testing, animal studies, and labeling to support premarket submissions for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.
12/23/2021
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