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Home » Devicemakers Call for Changes in FDA Guidance on Physiologic Closed-Loop Control Systems
Devicemakers Call for Changes in FDA Guidance on Physiologic Closed-Loop Control Systems
The FDA should consider broadening the scope of its draft guidance, “Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology,” device manufacturers said in written comments to the agency on the draft, which was released for comment on Dec. 23, 2021.