Description
Thisguidanceis intended to provide recommendations to Sponsors planning to develop and submit an Investigational Device Exemption (IDE) or premarket approval (PMA) application for an Artificial Pancreas Device System (APDS) for single patient use in the home environment. For the purposes of this document, the APDS refers to low glucose suspend systems, as well as closed loop control systems. FDA recognizes the need for guidance on the least burdensome means of development for these innovative device systems. Due to the evolving nature of these device systems, it is expected that they will develop incrementally. The recommendations contained in this guidance are intended to provide adequate guidance and instruction to facilitate the development and marketing of the APDS while, at the same time, allowing sufficient flexibility to accommodate the different approaches that Sponsors may wish to take.
Scope & Applicability
Product Classes
10Considered a device with a Major Level of Concern under the superseded guidance.; Guidance for IDE and PMA applications for these systems; The subject of the guidance document regarding IDE and PMA applications.; The APDS development process should include human factors/usability testing.; Each step is designed to test specific aspects of the APDS functionality; clinical expectations of clinical studies for artificial pancreas device systems; The subject of the pivotal trial and labeling require
recommend comparing outcomes between patients using sensor-augmented pump control, and patients using the APDS
Validation of certain in vitro diagnostic devices (IVDs) for emerging pathogens; Validation of certain IVD devices for emerging pathogens
The guidance provides recommendations for IDE and PMA applications for these systems.; autonomous systems that modulate insulin delivery
A type of Artificial Pancreas Device System.
A type of Artificial Pancreas Device System.
reduces likelihood of hypoglycemic event by suspending insulin delivery
adjusts insulin dosing if glucose levels reach predetermined thresholds
fully automated system that sets target glucose levels
Generally recommended for Enhanced Documentation; Regulatory classification mentioned for implantable sensors and HPV tests; Mentioned in the context of an in vitro nucleic acid test for CMV DNA.
Stakeholders
5Governs top dose in clinical studies
Way questions are framed is critical to collecting unbiased patient input
Veterinarian responsible for selecting anesthetic regimens and conducting field studies
Target population for dosing and safety assessment
Entity responsible for submitting applications under section 524B
Regulatory Context
Attributes
10Level of documentation required based on risk; higher documentation threshold for software functions; Risk-based documentation category requiring more detail; Outcome for software functions where failure presents a probable risk of death or serious injury; Outcome for devices where software failure presents a probable risk of death or serious injury.
Performance characteristic to be validated
Uncertainty of measurement parameter
Systematic errors introduced due to sampling or measurement.
Performance characteristics including Analytical specificity
A performance characteristic that may require validation testing.
Baseline characteristic and primary endpoint in diabetes studies.
coefficient of variation and standard of deviation
measures how successfully an APDS is able to keep glucose within a pre-defined range
convey the use(s) for which the drug has been shown to be safe and effective
Identified Hazards
Hazards
9Safety concern addressed through bench testing.; bench testing performed to show catheter occlusion does not occur
Monitored by measuring urine ketones and capillary blood ketone levels
Mitigated through training on the operation of the APDS
Risk caused by insulin crystallization during pump shutoff periods.
prior knowledge from product development, e.g., on leachables
Sponsor should also provide a safety evaluation of any extractables
Potential errors include use of an expired sensor.
Potential errors include improper anatomical placement of CGM.
hazards related to human-automation interactions and cognitive limitations
Related CFR Sections (8)
- 21CFR812.30§ 812.30 FDA action on applications.
(a) Approval or disapproval. FDA will notify the sponsor in writing of the date it receives an application. FDA may approve an investigation as proposed, approve it with modifications, or disapprove it. An investigation may not begin until:Read full regulation →
- 21CFR812.20§ 812.20 Application.
(a) Submission.Read full regulation →
- 21CFR812.46§ 812.46 Monitoring investigations.
(a) Securing compliance. A sponsor who discovers that an investigator is not complying with the signed agreement, the investigational plan, the requirements of this part or other applicable FDA regulations, or any conditions of approval imposed by the reviewing IRB or FDA shall promptly either securRead full regulation →
- 21CFR812.43§ 812.43 Selecting investigators and monitors.
(a) Selecting investigators. A sponsor shall select investigators qualified by training and experience to investigate the device.Read full regulation →
- 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 →
- 21CFR812.27§ 812.27 Report of prior investigations.
(a) General. The report of prior investigations shall include reports of all prior clinical, animal, and laboratory testing of the device and shall be comprehensive and adequate to justify the proposed investigation.Read full regulation →
- 21CFR814.15§ 814.15 Research conducted outside the United States.
(a) Data to support PMA. If data from clinical investigations conducted outside the United States are submitted to support a PMA, the applicant shall comply with the provisions in § 812.28 of this chapter , as applicable.Read full regulation →
- 21CFR3.2§ 3.2 Definitions.
For the purpose of this part:Read full regulation →
Related Warning Letters (10)
- 2025-09-09
Clinical Investigator
Shirish M. Gadgeel, M.D.
- 2025-08-26
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
CCIC Huatongwei International Inspection Co., Ltd.
- 2025-08-26
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Jiangsu Kerbio Medical Technology Group Co.
- 2025-07-15
Clinical Investigator
Mark J. Savant, M.D
- 2025-05-20
Bioresearch Monitoring Program/Institutional Review Board (IRB)
United Health Products, Inc.
- 2025-03-25
Clinical Investigator
Americo F. Padilla, M.D.
- 2024-11-05
Institutional Review Board (IRB)
Armstrong County Memorial Hospital
- 2024-10-22
Clinical Investigator
Namita A. Goyal, M.D.
- 2024-10-08
Institutional Review Board (IRB)
Louisiana State University Health Science Center IRB
- 2024-09-11
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Mid-Link Testing Company, Ltd
See Also (8)
- FDA Decisions for Investigational Device Exemption Clinical Investigations: Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff (Status: Final)
- Adaptive Designs for Medical Device Clinical Studies: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions: Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators and Food and Drug Administration Staff (Status: Final)
- Investigational IVDs Used in Clinical Investigations of Therapeutic Products: Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards (Status: Draft)
- Research Involving Children as Subjects and Not Otherwise Approvable by an Institutional Review Board: Process for Referrals to Food and Drug Administration and Office for Human Research Protections: Draft Guidance for Institutional Review Boards, Investigators, and Sponsors (Status: Draft)
- Guidance Document for the Preparation of IDEs for Spinal Systems - Guidance for Industry and/or FDA Staff (Status: Final)
- In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions: Guidance for Industry and FDA Staff (Status: Final)
- Bioresearch Monitoring Technical Conformance Guide (Status: Final)