By John Smith
The FDA has proposed amendments to its regulations governing the classification and reclassification of medical devices. These changes are intended to bring the agency’s process in line with the requirements of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, and to clarify the meaning of terms related to device classification and reclassification. A proposed rule describing the new procedures was published to the Federal Register last week.
Under the new process, the FDA will reclassify devices through administrative order. Before publishing a final order for a device reclassification, however, the agency must first publish a proposed order in the Federal Register, allowing for comments to be considered. The proposed order must include:
In addition, the FDA must hold a device classification panel meeting before the final order is published.
The proposed amendments also include revisions to the definitions of class I, II, and III devices. These definitions are intended to “reflect a key principle underlying device classification, namely, that a reasonable assurance of safety and effectiveness is necessary for all three device classes; however, the level of regulation necessary to provide such assurance should be closely tailored to the risk presented by a type of device,” according to the proposed rule.
Among the definitions is a clarification of what constitutes a high risk device. The proposed rule identifies five categories of devices that would be classified as class III based on the risks, benefits, and available controls for the three device classes:
You can learn more about the proposed Medical Device Classification Procedures here.
The FDA is accepting comments through June 23, 2014.