Modernizing Device Regulation

At what point does a modification of a device warrant an entirely new approval process? And who should make that decision? Dr. Alan Garber describes how the FDA might best approach its role as a device regulator. The Food and Drug Administration (FDA) is known for its rigor in regulating drugs, not devices. That may be about to change. In recent years, well-publicized device recalls and lawsuits have led to complaints that the FDA does not do enough to keep unsafe devices off the market. The failure of some devices, such as implantable defibrillators, could pose deadly risks. Fundamental differences between devices and drugs have important implications for FDA regulation. A typical device is an engineered product, rather than a chemical compound like a conventional drug or a biologic agent. The effects of a minor modification in . . .