FDA Issues Final Rule on Medical Device Classification Procedures

By Véronique Li* — On December 17, 2018, FDA published a final rule, Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures, to amend its regulations governing classification and reclassification of medical devices to align with the relevant portions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA).  We previously blogged on the proposed changes here.  While FDA said that the final rule allows it to classify any device from class III to class I or class II, a process known as down-classification, it also makes it easier for the agency to increase product classification based on new or changing information to more appropriately reflect device risk.  FDA’s easier ability to up-classify devices may be particularly relevant in light of the Agency’s November 2018 announcement on new…

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