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USFDA MD Guidance: AST System Devices, Technical Considerations & Electronic Submission Template

Recently (29th September 2023) the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released multiple guidances.

This (final) guidance outlines FDA's recommendations regarding the marketing submission content for predetermined change control plans (PCCPs) for new AST system devices, describes an enforcement policy for legacy AST system devices, and clarifies the process for including a cleared PCCP or breakpoint change protocol as a reference in a new 510(k) application for an AST system device.

In this guidance, FDA provides recommendations for submitting content for predetermined change control plans (PCCPs) for new AST system devices, describes an enforcement policy for legacy AST system devices, and clarifies how a PCCP or breakpoint change protocol can be incorporated by reference into a new 510(k) submission.


This FDA provides recommendations in this document about design considerations, nonclinical testing, animal studies, and labeling for medical devices with closed-loop physiology.


This guidance applies to the design and testing of a device incorporating physiologic closed-loop control technology and a number of factors will affect the design and testing. These include but are not limited to, the energy or article to be delivered, the environment in which it will be used, the level of automation, the training of the user population, the patient population, the properties of the physiologic-measuring sensor, the method of designing the control algorithm, as well as the delivery system.



This draft guidance is intended to represent one of several steps in meeting FDA's commitment to developing electronic submission templates to serve as guided submission preparation tools for industry to enhance submission consistency and efficiency in the review process.

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