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Medical Devices; Immunology and Microbiology Devices; Classification of Human Leukocyte, Neutrophil and Platelet Antigen and Antibody Tests (Proposed Rule) Preliminary Regulatory Impact Analysis (PRIA)

The Food and Drug Administration (FDA, the Agency, or we) is proposing to classify Human Leukocyte Antigen (HLA), Human Platelet Antigen (HPA), and Human Neutrophil Antigen (HNA) devices, a generic type of device, into class II (special controls). FDA is identifying proposed special controls for HLA, HPA, and HNA devices that are necessary to provide a reasonable assurance of safety and effectiveness. FDA is also giving notice that we do not intend to exempt these device types from premarket notification requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA is publishing in this document the recommendations of the Blood Products Advisory Committee, serving as a device classification panel, regarding the classification of these devices.  After considering public comments on the proposed classification, FDA will publish a final regulation classifying these device types.

Regulatory Impact Analysis

Medical Devices; Immunology and Microbiology Devices; Classification of Human Leukocyte, Neutrophil and Platelet Antigen and Antibody Tests (Proposed Rule) PRIA -(PDF- 260KB)

Federal Register: 87 FR 3250, January 21, 2022

Docket: FDA-2021-N-0851

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