FDA Moves to Simplify Medical Device Classification Procedures

While it may seem counterintuitive to industry, the Center for Devices and Radiological Health (CDRH) within the U.S. Food and Drug Administration (FDA) is looking to simplify processes and also make them more transparent.

The agency recently proposed amending its regulations governing the classification and reclassification of medical devices relating to a device’s risk category—class I, II or III. The changes, according to FDA, are intended to bring the agency’s processes in line with the requirements outlined as part of 2012’s Food and Drug Administration Safety and Innovation Act (FDASIA), and to clarify the meaning of terms related to device classification and reclassification. A proposed rule describing the new procedures was published in the Federal Register on March 25, and the FDA is accepting the comments and feedback through June 23.

“FDA is proposing these revisions to update its regulations to reflect these and other changes, and to ensure classification of devices in the lowest regulatory class consistent with the protection of the public health and the statutory scheme for device regulation,” agency officials noted in the text of the proposed rule.

FDASIA amended the Food, Drug & Cosmetic Act to allow the FDA to reclassify medical devices by administrative order rather than the rulemaking process.

As part of the new process, the FDA must hold a device classification panel meeting before the final order is published that can take place before or after the order’s publishing. However, before publishing a final order for a device reclassification, the FDA first must publish a proposed order in the Federal Register, allowing for comments to be considered.
The proposed order must include:

• Substantive summary of valid scientific evidence, including the public health benefits and device risks;
• When reclassifying from class II to class III, an explanation that general and special controls are insufficient to reasonably assure safety and effectiveness; and
• When reclassifying from class III to class II, an explanation that general and special controls are sufficient to reasonably assure regulators of safety and effectiveness.

The proposed amendments also include revisions to the definitions of class I, II and III devices. The 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 proposal.

Among the definitions included in the proposal 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:

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

Interestingly for medical device makers, the FDA clarifies the third point (above), “Devices for which a full review of manufacturing information is necessary,” with the following explanation: Even when the risk/benefit profile of a device is well-established, for certain potentially high-risk devices, the risks may be of a type or degree that can only be adequately addressed by relatively stringent controls. Among the relatively stringent controls applied to class III devices are, in addition to the requirement for approval of an application containing valid scientific evidence independently establishing reasonable assurance of safety and effectiveness for the device, the requirement to provide full manufacturing information about a device for FDA review before it may enter the market. FDA may be aware, for example, from experience with a particular device type, that certain aspects of the manufacturing process are critical to the safety or effectiveness of the device, which makes review of the manufacturing process necessary prior to marketing.”

More details can be found in the Federal Register notice at www.federalregister.gov/articles/2014/03/25/2014-06364/medical-device-classification-procedures. The comment period ends on June 23.