2024-20081. Medical Devices; Gastroenterology-Urology Devices; Classification of the Hemodialyzer With Expanded Solute Removal Profile

Table 1—Hemodialyzer With Expanded Solute Removal Profile Risks and Mitigation Measures

Identified risks to health	Mitigation measures
Adverse tissue reaction	Biocompatibility evaluation, Pyrogenicity testing, and Non-clinical performance testing.
Infection or pyrogen reaction	Labeling, Pyrogenicity testing, Sterilization validation, Non-clinical performance testing, and Shelf-life testing.
Inadequate or incomplete treatment	Non-clinical performance testing, Labeling, and Shelf-life testing.
Clearance of essential blood substances or medications	Non-clinical performance testing, Clinical performance testing, Labeling, and Shelf-life testing.
Blood loss or blood cell destruction	Non-clinical performance testing, Labeling, and Shelf-life testing.
Blood leak into the dialysis fluid	Non-clinical performance testing, Labeling, and Shelf-life testing.
Air or particle embolism	Non-clinical performance testing, Labeling, and Shelf-life testing.
Fluid imbalance	Non-clinical performance testing and Labeling.
Acid-base imbalance	Non-clinical performance testing and Labeling.