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(a) Identification. A container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions is a device intended for medical purposes that is used to process and store Red Blood Cell components and reduce oxygen levels in the storage environment.
(b) Classification. Class II (special controls). The special controls for this device are:
(1) The intended use of the device must specify:
(i) The Red Blood Cell components that can be processed and stored including acceptable anticoagulants and additive solutions;
(ii) The hold time after Red Blood Cell component collection;
(iii) The processing capacity (volume) of the device; and
(iv) The storage temperature and dating period of processed Red Blood Cell components.
(2) Studies must demonstrate that the device is biocompatible and include detailed documentation of the biocompatibility evaluation.
(3) Performance testing and nonclinical studies must include a detailed study of leached materials extracted under conditions similar to clinical usage of the device, and a toxicologic risk assessment of those extracted or leached materials.
(4) Performance testing must support sterility of the device and include sterilization validation, endotoxin testing, and container closure integrity evaluation.
(5) Nonclinical and clinical studies must include evaluation of red blood cell quality throughout the duration of storage based on in vitro and in vivo studies, including hemolysis and red blood cell survival and recovery.
(6) Performance studies must include:
(i) Detailed documentation of functional and mechanical testing, including evaluation of oxygen and, if applicable, carbon dioxide levels during Red Blood Cell components storage; and
(ii) Detailed documentation of device shelf-life testing demonstrating continued sterility, package integrity, and functionality over the identified shelf life.
(7) The labeling must include a contraindication against processing Red Blood Cell components collected from donors with hemoglobin S.
[88 FR 77199, Nov. 9, 2023]
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