FDA Proposes Changes To Medical Device Classification/Reclassification Procedures

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:

• A summary of scientific evidence that includes public health risks and benefits of the device
• If the device is being reclassified from class II to III, an explanation as to why general and special controls are insufficient to reasonably assure safety and effectiveness of the device
• If the device is being reclassified from class III to II, an explanation as to why general and special controls are sufficient to reasonably assure safety and effectiveness of the device.

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:

1. Devices that present known risks that cannot be controlled
2. Devices for which the risk-benefit profile is unknown or unfavorable
3. Devices for which a full review of manufacturing information is necessary
4. Devices for which premarket review of any change affecting safety or effectiveness is necessary
5. Combination products involving a medical device and either a drug or biological product

You can learn more about the proposed Medical Device Classification Procedures here.

The FDA is accepting comments through June 23, 2014.