Description
This 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.
Scope & Applicability
Product Classes
6A system consisting of sensors, actuators, and control algorithms that adjusts or maintains a physiologic variable
The primary subject of the guidance regarding technical considerations.
verifying the EDDO of flow rate accuracy should account for any before-use instructions
Host medical device for PCLC technology
Physiologic Closed-Loop Control medical devices providing automated titration or adjustment of therapy.
Physiologic Closed-Loop Control technology medical devices; medical devices with physiologic closed-loop control technology; Physiologic Closed-Loop Controlled medical devices discussed throughout the guidance
Stakeholders
2the terms you and yours refer to medical device manufacturers
Entity required to conduct postmarket surveillance; entity responsible for submitting postmarket surveillance plans; Entity holding the approved PMA, HDE, or cleared 510(k); The entity responsible for conducting postmarket surveillance and submitting reports.; Entity that can use the checklist as a reference for submissions.
Regulatory Context
Attributes
4response differences between patients; range of responses expected from different patients
A safety state the device enters during faults or unsafe conditions.
Sensor performance characteristic
response differences within an individual patient over time; degree to which an individual response can change over time
Identified Hazards
Hazards
10Potential automation-induced hazard; Tendency for users to give greater belief to information from automation without verification.; Automation-related hazard where users over-rely on automated systems
Automation-related hazard involving reduced vigilance
Safety risk in oxygenation devices if oxygen delivery falls below 21%.
Risk related to user interaction with multiple control modes
hazards related to human-automation interactions and cognitive limitations
Threats to the healthcare sector that can lead to patient harm; Technological characteristics that could be vulnerable; Threats that could negatively impact safety and effectiveness
hazards resulting from the PCLC device and its components
Potential automation-induced hazard
Reduction of user awareness due to automation of clinical decisions.
Reduction of decision-making ability due to consistent execution by automation.
Related CFR Sections (2)
- 21CFR814.20§ 814.20 Application.
(a) The applicant or an authorized representative shall sign the PMA. If the applicant does not reside or have a place of business within the United States, the PMA shall be countersigned by an authorized representative residing or maintaining a place of business in the United States and shall identRead full regulation →
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →
Related Warning Letters (10)
- 2025-12-09
CGMP/QSR/Medical Devices/Adulterated
Envoy Medical Inc.
- 2025-11-25
CGMP/QSR/Medical Devices/Adulterated
Hong Qiangxing Shenzhen Electronics Limited
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated
Contec Medical Systems Co., Ltd.
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Royal Philips
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Qianjiang Kingphar Medical Material Co Ltd.
- 2025-10-21
CGMP/QSR/Medical Devices/Adulterated
LEVO AG
- 2025-10-07
CGMP/QSR/Medical Devices/Adulterated
Technological Medical Advancements LLC
- 2025-09-23
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
The Richline Group, Inc.
- 2025-09-16
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
SeniorLife Technologies, Inc.
- 2025-08-26
CGMP/QSR/Medical Devices/Adulterated
Miach Orthopaedics
See Also (8)
- Pharmacogenetic Tests and Genetic Tests for Heritable Markers: Guidance for Industry and FDA Staff (Status: Final)
- Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems - Guidance for Industry and FDA Staff (Status: Final)
- The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Premarket Assessment of Pediatric Medical Devices: Guidance for Industry and FDA Staff (Status: Final)
- Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (Status: Draft)
- Saline, Silicone Gel, and Alternative Breast Implants: Guidance for Industry and FDA Staff (Status: Final)
- Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Medical Devices with Indications Associated with Weight Loss - Non-Clinical Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)