Description
FDA has developed thisguidance documentto assist industry in preparing Investigational Device Exemption (IDE) applications for nocturnal home hemodialysis (NHHD) systems. These dialysis devices are intended to administer dialysis therapy in the home setting, while the patient is expected to be asleep.
Scope & Applicability
Product Classes
5Devices intended to administer dialysis therapy in the home setting while the patient is asleep.
Nocturnal Home Hemodialysis system labeling requirements
A type of chronic hemodialysis that takes place in the home while the patient is sleeping.
Chronic hemodialysis in a clinical environment typically three times per week.
Nocturnal Home Hemodialysis systems level of concern is major
Stakeholders
2Entity responsible for submitting applications under section 524B
Person present throughout the dialysis treatment; person assisting the subject with home hemodialysis
Regulatory Context
Attributes
6Level 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.
Included in the definition of lot or batch for stand-alone software.
Parameter to be checked during monitoring
Previous risk classification for ultrasonic diathermy devices under superseded guidance.; FDA's classification of software for ultrasonic diathermy devices
Risk-based approach to determine information amount for premarket submission
Categorization (minor, moderate, major) for software risk.
Identified Hazards
Hazards
3NHHD systems are classified as significant risk devices.
precaution not to override the air embolism/foam detector
precaution regarding susceptibility to interference
Related CFR Sections (8)
- 21CFR812.20§ 812.20 Application.
(a) Submission.Read full regulation →
- 21CFR812.5§ 812.5 Labeling of investigational devices.
(a) Contents. An investigational device or its immediate package shall bear a label with the following information: the name and place of business of the manufacturer, packer, or distributor (in accordance with § 801.1 ), the quantity of contents, if appropriate, and the following statement: “CAUTIORead full regulation →
- 21CFR812.25§ 812.25 Investigational plan.
The investigational plan shall include, in the following order:Read 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 →
- 21CFR812.3§ 812.3 Definitions.
(a) Act means the Federal Food, Drug, and Cosmetic Act (sections 201-901, 52 Stat. 1040 et seq., as amended ( 21 U.S.C. 301-392 )).Read full regulation →
- 21CFR876.5600§ 876.5600 Sorbent regenerated dialysate delivery system for hemodialysis.
(a) Identification. A sorbent regenerated dialysate delivery system for hemodialysis is a device that is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a sorbent cartridge and the means to circulate dialysate through tRead full regulation →
- 21CFR876.5820§ 876.5820 Hemodialysis system and accessories.
(a) Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and acceRead full regulation →
- 21CFR876.5860§ 876.5860 High permeability hemodialysis system.
(a) Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiaRead 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.
- 2025-09-09
Clinical Investigator
Shirish M. Gadgeel, M.D.
See Also (8)
- Guidance Document for the Preparation of IDEs for Spinal Systems - Guidance for Industry and/or FDA Staff (Status: Final)
- Preparation and Review of Investigational Device Exemption Applications (IDEs) for Total Artificial Discs: Guidance for Industry and FDA Staff (Status: Final)
- Saline, Silicone Gel, and Alternative Breast Implants: Guidance for Industry and FDA Staff (Status: Final)
- Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery - Guidance for Industry (Status: Final)
- Investigational Device Exemption (IDE) Guidance for Retinal Prostheses: Guidance for Industry and FDA Staff (Status: Final)
- Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Guidance for Industry and FDA Staff (Status: Final)
- Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies (Status: Final)