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March 21 --The Food and Drug Administration March 21 proposed changes to how it classifies and reclassifies medical devices.
In a proposed rule (FDA-2013-N-1529) that was published in the March 25 Federal Register (79 Fed. Reg. 16252), the agency proposed to revise its device reclassification process to conform with the Food and Drug Administration Safety and Innovation Act (FDASIA). The law permits the FDA to change the classification of a device by administrative order instead of by regulation based on new information regarding the device.
Unrelated to FDASIA, the FDA also proposed to update its definitions of class I (low risk), class II (medium risk) and class III (high risk) devices to better reflect the level of risk associated with the device and the level of regulation needed to provide a “reasonable assurance of safety and effectiveness.”
Additionally, the proposed rule would change the definition of class III “to provide greater clarity regarding which devices fall within this class, and to improve transparency and predictability in device classification and reclassification decisions,” the agency said.
Comments on the proposed rule are due June 23. Comments on information collection issues under the Paperwork Reduction Act of 1995 are due April 24.
According to the FDA, class III devices are the highest risk because they are intended for use in supporting or sustaining human life, are of “substantial importance in preventing impairment of health” or present a “potential unreasonable risk” of illness or injury.
The current regulatory definition doesn't explain the concept of when insufficient information exists to determine that general and special controls would provide a reasonable assurance of safety and effectiveness, the agency said.
The proposed rule would “identify those potentially high risk devices for which insufficient information exists to determine that special and general controls would provide” a reasonable assurance of safety and efficacy (RASE.)
The proposed regulation would identify five categories of devices for automatic classification into class III:
• devices that present known risks that can't 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 (part drug and part device).
Bradley Merrill Thompson, an attorney at Epstein Becker & Green PC in Washington and general counsel to the Combination Products Coalition, told Bloomberg BNA the proposed regulation makes sense for combination products “because it merely codifies the existing practice of placing a drug/device combination product in class III where the device is the primary mode of action, but the drug is unproven.”
According to Thompson, it makes sense that a drug that hasn't yet been proven safe and effective, when bundled with a device, would lead the device to be placed in class III.
However, Thompson said he was concerned that the proposal states that combination products retain the regulatory identities of their constituent parts but at the same time still recognizes combination products as distinct from products that are sold solely as drugs, devices or biologicals and that might be subject to specialized regulatory controls.
“There is a long-standing debate regarding whether combination products are merely regulated as their underlying constituent parts, or as something of a new category,” Thompson said. “We have always resisted the notion that somehow combination products rise to the level of the new category, and it is unsettling for FDA to suggest that there might be specialized controls heaped on these products beyond the existing drug and device requirements. It's a vague statement, so I don't know exactly what they have in mind, but I consider it quite ominous.”
A device industry trade group, the Advanced Medical Technology Association (AdvaMed), also commented on the new proposed rule. Janet Trunzo, AdvaMed's senior executive vice president, technology and regulatory affairs, said in a statement, “We are reviewing the contents of FDA's proposed rule and will be looking to see if it meets the spirit and intent of the FDA Safety and Innovation Act. It is extremely important that the appropriate procedural steps as outlined under FDASIA that allow for due process are followed.”
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The proposal is at http://www.gpo.gov/fdsys/pkg/FR-2014-03-25/html/2014-06364.htm.
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