Joe Lieberman: “I rise to address Senator Reed's amendment to S. 830, the FDA reform bill. The proponents of the amendment have failed…”

“I rise to address Senator Reed's amendment to S. 830, the FDA reform bill. The proponents of the amendment have failed to distinguish between devices that are substantially equivalent to devices the FDA has approved and devices for which no predicate exists. That distinction is central to the regulatory scheme for device approval. Most medical devices brought to the market represent a small incremental change. Around 95% of medical device approvals granted by the FDA involve devices that are substantially equivalent to a device already approved by the agency. Most devices are not breakthroughs. They are not devices with bold new uses. They do not represent a sharp departure in medical science. They are devices with a foundation of testing, experience in the field, and most important, devices with a foundation in previous FDA approval. Policies and regulations that are appropriate for devices without a predicate are not appropriate where devices are substantially equivalent to a device that has already received the FDA stamp of approval. If each new device represented such a break with the past, it would be sensible to fully reexamine safety and efficacy every time FDA was asked to grant approval. But in a world of small changes, this unwarranted bureaucratic impediment would strangle progress, limit the benefits available to the public from technological advances, and yield little if any public health benefit.”