Experts Divided On FDA's Approach To Medical Device Regulation

By Jof Enriquez,
Follow me on Twitter @jofenriq

The U.S. Food and Drug Administration (FDA) attempts to walk the fine line between protecting public health safety and encouraging the development of innovative medical devices. There is no shortage of differing opinions on whether or not the FDA’s current regulatory approach towards medical devices should be overhauled, slightly tweaked, or stay the course.

When the Wall Street Journal recently talked to three experts about the topic in a roundtable discussion, their views reflect how divided stakeholders are on device regulation.

Scott Gottlieb, former FDA deputy commissioner, believes that the agency has deviated from its original mandate by overreaching in areas it was not designed to monitor.

In the interview, he says that the FDA has unfortunately shifted towards applying a “much more uniform and druglike approach to its regulation of medical devices,” instead of focusing on risks associated with a particular device. Gottlieb says that this approach has led to the creation of unnecessary hurdles for newly developed devices.

He also describes as “unethical” and “unnecessary” dummy surgical procedures that he says the FDA has asked manufacturers to conduct as part of the review process. According to him, such procedures place the patient at risk without clear benefits.

However, another expert interviewed by the WSJ says that those placebo-controlled device trials were not required by the FDA. Bradley Merrill Thompson, a device attorney with the firm Epstein, Becker & Green, says companies are actually the ones who suggest these trials, and the agency merely permits them.

Thompson also countered Gottlieb’s expressed view that the FDA is unnecessarily clamping down on low-risk consumer apps by treating them as medical devices.

“In the last couple of years, [FDA] has sought to reduce, not enlarge, its regulatory oversight,” Thompson told the WSJ. “For example, it has deregulated the hardware and software that takes data from medical devices like a blood glucose meter and transmits it for storage and display. That was a big step forward.” (For more on this topic, see FDA Cuts Its Oversight Of Medical Device Data Systems.)

Rather than sweeping regulatory reform, Thompson is in favor of “continuous improvement guided by continuous review of agency performance data as well as marketplace and scientific trends.”

Meanwhile, a third expert in the discussion, Rita Redberg, a cardiology professor at the University of California, San Francisco (UCSF), says that only a few percent of all medical devices are required to undergo a pathway that lacks stringent evidence-based clinical trials.

“As a cardiologist taking care of patients every week, I see too many whose lives have been harmed and who have suffered greatly from untested or inappropriate devices,” she told the WSJ. She points out an increasing array of high-risk devices — morcellators, metal-on-metal hip implants, pelvic mesh implants, inferior vena cava filters — that were approved but were later shown to be dangerous and even lethal to many patients. 

“Simply put, for the vast majority of medical devices, there is NO requirement to demonstrate safety and effectiveness,” says Redberg.

She suggests establishing national, publicly available registries of devices and procedures for tracking real-time outcomes and preventing catastrophic device failures.

All three experts lament the fact that device failures have caused deaths and injuries to many patients. However, Gottlieb and Thompson say that simply requiring manufacturers to perform larger and more clinical trials to prevent these occurrences will not ensure device safety, according to the WSJ.

“My concern is that a lot of the fundamental questions about device safety turn on issues of biomechanical performance,” says Gottlieb. “For example, some common questions are how resilient an implanted valve will be to the shearing effects of blood flow, a joint to constant stresses, or the durability of a pacemaker’s circuits.”

According to an FDA report cited by the WSJ, the number of defective devices that were recalled nearly doubled in the decade ending in 2012. However, Gottlieb and Thompson say that everyone must consider the overall picture.

“Out of all of the thousands of medical devices that the FDA clears each year, how many turn out to be unsafe or ineffective? Not many,” says Thompson. “But further, and equally importantly, how effective are alternative regulatory systems in approving important new medical devices in a timely way? Changing the system in a way that delays or even forecloses the sale of safe and effective breakthrough medical devices hurts patients, too.”

Gottlieb expressed the same view, saying, “Keep in mind that 99.8% of all medical devices have no serious adverse events associated with them. The U.S. is the gold standard when it comes to device safety.” He pointed out the implementation of the unique device identifier (UDI) as one initiative aimed at improving safety.

The U.S. Congress is working on separate measures to overhaul how the FDA regulates medical products. The nation’s largest medical device trade group, AdvaMed, also released a report that complements the language and scope of regulation over medical devices used in those legislative proposals, according to the Regulatory Affairs Professionals Society (RAPS).