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- CAP Urges FDA Against Reclassification of Histocompatibility Antigen Testing Devices
Working to improve diagnostic medical device regulations, the CAP urged the Food and Drug Administration (FDA) to reconsider plans to reclassify three histocompatibility antigen devices due to concerns over future availability and other uncertainties. The FDA is proposing this reclassification into class II with special controls as a necessary measure to prevent risk from medical device malfunction in the transplantation and transfusion setting.
The CAP advocates ensuring regulations protect patients without overburdening pathologists and laboratories. In the April 21 letter, the CAP asked the FDA not to place Human Leukocyte Antigen (HLA), Human Platelet Antigen (HPA), and Human Neutrophil Antigen (HNA) devices as a generic type of device into class II of special controls. The CAP said it understood that test manufacturers need such guidance to ensure safe and effective HLA, HPA, and HNA testing. However, the proposed regulation will likely negatively influence the use and availability of these devices, and possibly raise additional questions regarding medical liability.
In the letter, the CAP recognized that the HLA, HPA, and HNA testing market is expected to significantly grow due to an increasing number of organ transplants. The reclassification may have an impact on the availability of HLA, HPA, and HNA clinical testing because of the limited number of methods available, the CAP said.
The CAP will continue to engage with the FDA on this issue.