01.22.19

FDA Issues Statement on Steps to Strengthen FDA’s 510(k) Program for Premarket Review of Medical Devices

Source: US Food & Drug Administration

FDA Commissioner Scott Gottlieb, MD; and Jeff Shuren, MD, Director of the Center for Devices and Radiological Health, issued the following statement regarding an initiative to strengthen the agency’s 510(k) program:

“In 2018, the FDA’s Center for Devices and Radiological Health achieved several new milestones, including a record-setting year for approvals of novel medical devices. We also focused 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.

We articulated those concepts early in the year as part of the FDA’s Medical Device Safety Action Plan and most recently with our announcement of changes to strengthen the 510(k) program. The Safety Action Plan described actions we’ve taken over the past several years to enhance device safety and outlined our vision for how the agency can build on these initiatives to further assure the safety and effectiveness of medical devices.

As we start the new year, we’re dedicated to executing on the commitments we laid out last year and implementing our proposed new policies. As we outlined this past November, one of our goals is to ensure that the 510(k) program is keeping pace with the important innovations we’re seeing in device development. We believe this means that, where appropriate, new medical devices coming to market under the 510(k) pathway should either account for advances in technology that can improve the safety or performance of these products, or demonstrate that they meet more modern safety and performance criteria. Today, we’re pleased to announce two developments toward advancing this policy effort.

First, the FDA posted its final guidance establishing the framework for the Safety and Performance Based Pathway. The new name for this guidance reflects our focus on advancing new products with improved safety and performance. This option for 510(k) clearance will modernize our 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 of their new products to legally marketed devices. Under the traditional approach, manufacturers often rely on comparative testing against a device already on the market, known as a predicate device, to show that a new device is as safe and effective as the predicate device. But, the predicates may be older and, consequently, they may not reflect the modern technology embedded in new devices of that type.

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 note that devices using this pathway will still have to meet our current standards for reasonable assurance of safety and effectiveness before they can be marketed. The benefit of this approach is that the pathway will benchmark modern technology against modern standards while, at the same time, offering a potentially more efficient way to demonstrate that a new device is substantially equivalent to devices already on the market, and thereby ensure patients have timely access to beneficial products. We also believe this new approach may drive greater market competition to develop safer devices. By using this pathway, manufacturers would have demonstrated that their products meet objective safety and performance criteria that are based on modern technological principles.

This year, we’ll build on today’s final guidance by establishing safety and performance criteria for certain well-understood device types. We’ll issue these criteria through guidance, which includes an opportunity for public comment prior to using them under the new pathway.

In addition, today, the FDA is soliciting public comment on steps that we could take to further encourage medical device manufacturers to develop innovations that enhance the safety of 510(k) devices. One possible way to advance this goal could be to focus on the use of more modern predicate devices.

As we noted above, older predicates might not closely reflect modern technology used in new devices. While this doesn’t mean the products that reference those predicates are unsafe, it does mean there is an opportunity to examine how we can enhance the process to ensure devices are continually improving so patients can reap the benefits of modern advancements.

To that end, as we discussed in our November statement, we’re considering whether, in addition to the information in the 510(k) database, the FDA should post on its website a list of FDA-cleared devices that demonstrated substantial equivalence to older predicate devices. Doing so would create more transparency about these technologies, with the goal of driving device manufacturers to offer patients devices with 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. We’re seeking comment on this new proposed approach, as well as other questions that will help inform our regulatory policy development, including:

  • Should the FDA make public a list of devices, or manufacturers who make technologies, 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 our point of reference?
  • Are there other and/or alternative actions we 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 at least some older devices ineligible as predicates?

The FDA has opened a docket to receive comment on these questions, and we request that any responses be provided within 90 days. We’re committed to engaging with the public on our approach to 510(k) modernization and look forward to receiving and reviewing this feedback.

We believe firmly in the merits of the 510(k) process. 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.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.”

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