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. ...
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."