The U.S. Food and Drug Administration has a proposed a rule that would allow reclassification of devices via an administrative order published in the Federal Register.
The proposed rule would conform to the provisions in the Food and Drug Administration Safety and Innovation Act, enacted July 9, 2012, which requires a device to be reclassified through an official administrative order. Before the administrative order can be published, the FDA is required to publish a proposed order in the Federal Register and consider any comments received there. Then, the FDA has to hold a device reclassification panel.
The FDASIA amended the classification rules of the Food, Drug and Cosmetic Act, which said the FDA can reclassify a device by an administrative order published in the Federal Register based upon "new information," such as information as a result of reevaluation from when the device was originally classified or information not yet available or developed at the original time.
The goal of the proposed rule is to "codify the procedures and criteria that apply to classification and reclassification of medical devices and to provide for classification of devices in the lowest regulatory class consistent with the public health and the statutory scheme for device regulation," according to the proposed rule in the Federal Register.
The proposed rule also discusses amending and updating a number of other reclassification provisions to help clarify term meanings.
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