FDA Addresses Device Safety Process, But Will It Be Enough?

By John Palmer

The FDA has announced that its Center for Devices and Radiological Health achieved several new milestones in late 2018 aimed at making medical devices safer, as well as giving healthcare administrations more input in what devices should be approved.

The FDA, in a written statement, touted its “record-setting year” for approvals of novel medical devices, as well as focusing on advancing several meaningful initiatives and policy proposals aimed at enhancing the safety of medical devices, including the safety of devices cleared through the FDA’s 510(k) review process before going to market.

“We believe firmly in the merits of the 510(k) process,” the FDA said in a written statement released in late January. “Thousands of devices are cleared through this process each year and countless thousands more patients benefit from these technologies. In taking these new steps today, we’re reaffirming our commitment to continually strengthening our review process, so that it can continue to serve and protect American patients well for years to come.”

Premarket approval (PMA) is the most stringent FDA submission process, impacting about 10% of device applications today. Devices that qualify for premarket review are Class III, defined as devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. Examples of Class III devices covered by PMA include drug-eluting coronary stents, implantable pacemakers, spinal cord stimulation systems, and breast implants.

The 510(k) process is required by the FDA when introducing a medical device to the market for the first time, changing the indications for a previously cleared device, or making significant modifications to a previously cleared device. Typically, the FDA notifies a device manufacturer within 90 days for a traditional or abbreviated 510(k) or within 30 days for a special 510(k). If the device is cleared, the FDA affirms the device has been found to be substantially equivalent and can be marketed and commercially distributed within the United States.

To receive clearance, the FDA requires the demonstration of “substantial equivalence” to another legally U.S. marketed device, or predicate device. This means the new device must have the same intended use and same technological characteristics, or the same intended use and different technological characteristics that do not raise different questions regarding safety and effectiveness; the new device must also be demonstrated to be at least as safe and effective as the legally marketed device. A claim of substantial equivalence does not mean the new and predicate devices must be identical. A 510(k) includes several components, such as a description, indications for use, substantial equivalence discussion, and performance testing. Clinical testing is not typically required and is only requested in specific situations. When a device is cleared, it has been determined to be substantially equivalent to another legally marketed device via the 510(k) pathway.

The new FDA pathway is being called the “Safety and Performance-Based Pathway.” The name reflects the FDA’s focus on advancing new products with improved safety and performance. This option for 510(k) clearance is meant to help modernize the approach to moderate-risk devices by allowing manufacturers to use objective performance criteria established or recognized by the FDA to facilitate demonstration of substantial equivalence for their new products.

It’s a start, but for some medical safety device industry watchdogs, there is still a lot of work to be done.

“Regulation shouldn’t deprive society of valuable new technologies, but it also must ensure patients are kept safe from harmful devices,” says John Cherf, MD, MPH, MBA, chief medical officer of Chicago-based Lumere, an organization comprised of clinicians, researchers, pharmacists, and strategic thought leaders focused on helping health systems eliminate unwarranted clinical variation and cut unnecessary costs related to device and drug selection and utilization.

“The FDA has attempted to walk that fine line with both the 510(k) and PMA processes; however, there are some concerning issues with both,” Cherf says. “For example, 510(k) cleared devices do not require clinical testing to prove safety and efficacy in humans, and if a 510(k) cleared device is recalled, other devices that used this recalled device as a predicate for clearance do not need to notify users of the recall. In the PMA pathway, clinical trials are sponsored by the device manufacturer, and new clinical testing is not required for updated versions of a device that has minor changes.”

The FDA says that it plans to address such concerns, including the fact that predicates may be older and, consequently, may not reflect the modern technology embedded in new devices. For appropriate device types, the Safety and Performance-Based Pathway will ensure that the performance characteristics of new devices are evaluated against a set of objective, transparent, and well-validated safety and performance metrics.

“It’s important to acknowledge that older technologies sometimes become commodities, but they are often time honored,” says Cherf. “Some products become ‘mature’ with no further opportunity for improvement (or cost improvement). In many cases, changes to these ‘older’ technologies result in adverse effects. For example, there has been significant development of new hip and knee joint replacement technology over the past decade, such as gender-specific knees, high flex knees, rotating platforms, and alternative bearing surfaces. Except for improvements in polyethylene, these new innovations have not outperformed older, proven technology. In fact, ‘improvements’ such as ceramic-on-ceramic hips and metal-on-metal hips have resulted in poor outcomes, including high rates of hospital readmission and repeat surgical procedures.”

The FDA noted that devices using this pathway will still have to meet current standards for reasonable assurance of safety and effectiveness before they can be marketed. The benefit of this approach, the agency says, is that the pathway will benchmark modern technology against modern standards while offering a potentially more efficient way to demonstrate that a new device is substantially equivalent to devices already on the market—thereby ensuring patients have timely access to beneficial products.

“We also believe this new approach may drive greater market competition to develop safer devices,” the FDA statement said. “By using this pathway, manufacturers would have demonstrated that their products meet objective safety and performance criteria that are based on modern technological principles.”

The FDA said in addition to the information in the 510(k) database, it is considering posting on its website a list of FDA-cleared devices that have demonstrated substantial equivalence to older predicate devices. Doing so would create more transparency about these technologies, with the goal of encouraging manufacturers to offer devices that include the latest improvements.

“However, we recognize that for some types of well-established technologies there is not a need for improvements, and reliance on older predicates would not only be appropriate but necessary,” the FDA statement said.

Lumere, for its part, says there needs to be a third pathway that would sit between 510(k) and PMA; that way, a portion of the 90% of devices that pass through 510(k) could be required to demonstrate slightly more rigorous clinical evaluation without incurring the massive financial and time investment required with PMA.

“There is also room for significant improvement in post-market monitoring of the medical device safety,” says Eric Meizlish, co-founder and chief strategy officer for Lumere.

“This starts with the FDA making adverse event information more accessible and informative,” he notes. “Under the current process, patients are unaware about risks until a product is formally recalled, which impairs them from making informed decisions about their health. The establishment of a national device registry run by the FDA would ensure patients and caregivers could contemplate the likelihood of possible risks and engage with their physicians to determine their preferred treatment. “

A request for public input has been made by the FDA seeking comment on this new proposed approach. It also asks other questions that will help inform regulatory policy development, including the following:

  • Should the FDA make public a list of devices, or technology manufacturers, that rely on predicates that have been on the market for more than a certain number of years (e.g., 10 years)? If so, what would be an appropriate period of time?
  • Should the FDA consider using other criteria to inform its point of reference?
  • Are there alternative actions the FDA should take to promote the development and marketing of safer, more effective 510(k) devices?
  • Should the FDA consider certain actions that might require new authority, such as making some older devices ineligible as predicates?

John Palmer is a freelance writer who has covered healthcare safety for numerous publications. Palmer can be reached at johnpalmer@palmereditorial.com.