Bradley Merrill Thompson Quoted in “FDA Proposal Aims to Streamline Device Classification According to Risk”Bloomberg BNA's Medical Devices Law & Industry Report April 2, 2014
Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "FDA Proposal Aims to Streamline Device Classification According to Risk."
Following is an excerpt:
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. ?...
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. ?...
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.