Description
Thisguidance documentprovides recommendations for complying with special controls issued as part of the reclassification of Implanted Blood Access Devices for Hemodialysis into class II (special controls). The devices are intended to provide access to a patient’s blood for hemodialysis.
Scope & Applicability
Product Classes
6The primary subject of the guidance, recently reclassified to Class II.; The primary device category covered by this guidance.; Subject of the guidance document and regulatory classification
legally marketed device used for substantial equivalence comparison
Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
The regulatory classification for implanted blood access devices.
Guidance for industry and FDA staff regarding hemodialysis devices
Example of a common name for a blood access device
Regulatory Context
Attributes
5Regulatory status of the device under 21 CFR 876.5540(a)(1).
critical measurement parameter for blood damage
Classification of atherectomy devices for clinical trials
Determined by the sponsor for the investigational product.; investigational product(s) are stable over the period of use and only used within the current shelf life
Quality parameter that must remain unchanged for the policy
Identified Hazards
Hazards
4Potential complication associated with subclavian or femoral placement.
discovery of hemolyzed product
substances that may contribute to antimicrobial resistance
Potential complication specific to subclavian placement.
Related CFR Sections (5)
- 21CFR876.5540§ 876.5540 Blood access device and accessories.
(a) Identification. A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions anRead 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 →
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →
- 21CFR807.92§ 807.92 Content and format of a 510(k) summary.
(a) A 510(k) summary shall be in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence. FDA will accept summaries as well as amendments thereto until such time as FDA issues a determination of substantial equivalence. All 510(k) summaries shall conRead full regulation →
- 21CFR801.109§ 801.109 Prescription devices.
A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” canRead 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
- 2025-09-09
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.
- 2025-08-12
CGMP/QSR/Medical Devices/Adulterated
Spectra Therapy, LLC
- 2025-08-05
CGMP/QSR/Medical Devices/Adulterated
Mectronic Medicale S.R.L.
- 2025-07-15
Clinical Investigator
Mark J. Savant, M.D
- 2025-06-24
CGMP/QSR/Medical Devices/Adulterated
Aju Pharm Co., Ltd.
- 2025-05-27
CGMP/QSR/Medical Devices/Adulterated
Sedecal S.A.
See Also (8)
- Bioresearch Monitoring Technical Conformance Guide (Status: Final)
- Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Frequently Asked Questions About Medical Devices: Guidance For IRBs, Clinical Investigators, and Sponsors (Status: Final)
- Establishment and Operation of Clinical Trial Data Monitoring Committees: Guidance for Clinical Trial Sponsors (Status: Final)
- Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects: Guidance for Industry (Status: Final)
- Frequently Asked Questions – Statement of Investigator (Form FDA 1572): Guidance for Sponsors, Clinical Investigators, and IRBs (Status: Final)
- In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions: Guidance for Industry and FDA Staff (Status: Final)
- PET Drug Applications - Content and Format for NDAs and ANDAs_2011 (Status: Final)