FDA Reclassifies Several Medical Devices, Exemption Order

摘要

On November 7, 2017, the US Food and Drug Administration (FDA) reclassified the total 25-hydroxyvitamin D mass spectrometry test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the total 25-hydroxyvitamin D mass spectrometry test system's classification. The FDA took this action because it determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. It believes that this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens. A total 25-hydroxyvitamin D mass spectrometry test system is a device intended for use in clinical laboratories for the quantitative determination of total 25-hydroxyvitamin D in serum or plasma to be used in the assessment of vitamin D sufficiency.