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GUIDANCE DOCUMENT

Quality Assurance Guidelines for Hemodialysis Devices February 1991

Final
Docket Number:
FDA-2020-D-0957
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Devices and Radiological Health

This publication, "Quality Assurance Guidelines for Hemodialysis Devices," is an integral part of the Center's educational program in hemodialysis. It discusses quality assurance for water treatment equipment, equipment used to evaluate the acceptability of the dialysate concentrate, dialysate delivery equipment with its associated monitors and alarms, extracorporeal blood components, dialyzers, dialyzer reprocessing and testing equipment, and all other equipment associated with the dialysis procedure.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-0957.