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FDA Compliance

New Steps to Facilitate Medical Device Innovation

The least burdensome approach

Published: Tuesday, February 6, 2018 - 13:01

In recent days, the U.S. Food and Drug Administration (FDA) has committed to several new policies that will modernize the agency’s approach to regulation in the medical device system.

For instance, we announced our intention to propose an alternate approach to the traditional 510(k) clearance process, which will involve the use of modern, science-based, consensus standards along with FDA-developed performance criteria as the comparator for device review for certain well-understood technologies. The FDA currently compares new devices to predicate devices that can in many cases be as much as 40 years old. By modernizing the standards that the FDA uses to assess some new devices, it will make it easier to innovate these products, and adopt more up-to-date and rigorous benchmarks for evaluating their safety and effectiveness.

‘Least burdensome’

The FDA is taking another step to modernize its regulatory framework and make its review processes more efficient. It is issuing a new draft guidance that describes how it intends to implement provisions enacted by Congress to pursue the “least burdensome” means of assuring the safety and effectiveness of new devices so that innovations that benefit patients can reach them more efficiently.

Timely patient access to high-quality, safe, and effective medical devices requires that the FDA reduce or reform those outdated, unnecessary burdens in our regulatory approaches that can add to development costs or forestall beneficial innovation without also enhancing device safety and effectiveness.

The least burdensome approach is not new; however, recent legislation, as well as the opportunities offered by advances in science, call for updating this framework.

Since the passage of the Food and Drug Administration Modernization Act (FDAMA) in 1997, the FDA has been required to take a least burdensome approach to pre-market review of devices that are subject to a pre-market approval application (PMA) or pre-market notification (510(k)), the FDA issued guidance, and began to train staff on the least burdensome requirements shortly after FDAMA’s enactment.

While these initial efforts first established the principles of this least burdensome framework for device pre-market review, subsequent agency efforts—and especially new laws such as the 21st Century Cures Act in 2016—clarified and expanded the least burdensome concept. As a result, the concept has been increasingly integrated into the FDA’s culture and operations, and has become a guiding principle for the device center’s efficient, science-based regulation.

In new draft guidance on the Least Burdensome Provisions, the FDA defines least burdensome to be the “minimum amount of information necessary to adequately address a regulatory question or issue through the most efficient manner at the right time.” The new draft guidance also explains the FDA’s regulatory approach and delineates guiding principles that we propose to apply across the total product life cycle—beyond what Congress has required—including all device-related applications and interactions with the medical device industry.

By making sure our processes are efficient and our regulatory frameworks are better tailored to technology type and patient needs, we believe we can garner information about the safety and effectiveness of new devices in the pre- and post-marketing setting with less time and cost. Because we believe the application of these least burdensome principles will help drive the development of, and timely patient access to, safe and effective devices, we are committed to training all device center staff on the implementation of these principles, not just those involved in pre-market review as required by the Cures Act.

This balanced approach will allow the FDA to focus its resources on issues of highest public health concern. In just the past few years, we’ve seen notable results of our application of the least burdensome principles on medical device review, including reduction in review times and improved quality of applications. At the same time, we’re advancing the FDA’s gold standard for safety by taking additional steps, such as enhancing our pre- and post-market safety tools, including the establishment of a new pre- and post-market evaluation system (NEST).

The Cures Act extended the least burdensome provisions and their application to the pre-market review process in new ways. It streamlined the FDA’s ability to remove the 510(k) submission burden where no longer needed for certain lower-risk devices. This allowed the agency to free up review resources to focus on higher-risk devices. The application of the goals of the least burdensome approach also has resulted in new efforts to implement risk-based compliance policies. For example, through the implementation of a variety of new digital health policies since 2013—including those involving mobile medical apps and medical device data systems—the agency generally does not oversee low-risk products that are part of the fitness/wellness industry.

Applicability to other policies

The successes in the pre-market arena have encouraged the FDA to apply the least burdensome approach in many other device policies and programs. This includes the development of a more flexible framework for making benefit-risk determinations in support of PMA approvals and De Novo classifications; a new policy on early feasibility studies; and the wider use of Real-World Evidence, such as data gathered as a part of routine clinical care, such as in electronic health records and registries. We’ve also developed and incorporated new regulatory science tools in our review process, such as computer models, to make device development, assessment, and review safer, faster, and more efficient.

Each of these exemplifies the advances we’ve made in creating a more efficient regulatory process—and incorporating more modern evaluative tools and approaches—while enabling our scientists to get the safety and effectiveness information that they need to inform their decisions.

In extending these same principles, the FDA has embraced and led international harmonization efforts to identify areas where regulation is not achieving its intended goal, and may be adding undue burden and presenting an obstacle to beneficial innovation. For example, the FDA is a founding member of the International Medical Device Regulators Forum and led the forum’s working group that established the Medical Device Single Audit Program. Under this program, participating countries share their own inspections and rely on surveillance inspections conducted by or on behalf of other participating countries. The program potentially eliminates the need for participating device companies to prepare for multiple inspections while allowing government agencies to make better use of their limited resources. It shows how adopting the most efficient approach has set the FDA on a course to generate high-quality information at a potentially lower cost and burden to product developers and the agency.

Positive results

The resulting impact on public health from the FDA’s implementation of these and similar principles has been significant. In 2016, we approved 91 innovative devices as compared to 24 in 2009, the highest number since the start of the user fee program in 2003. This year, we may achieve a modern record when it comes to the number of innovative medical device approvals. In 2016, we also saw an increase in the number of high quality, safe, and effective devices of public health importance approved in the United States as the first commercial market, meaning that U.S. patients now have early access to critically important technologies, such as the first “artificial pancreas.”

Through the application of the least burdensome approach, we’ve moved much closer to achieving our vision of patients in the U.S. having access to high-quality, safe, and effective medical devices of public health importance first in the world. At the same time, we’re setting the FDA on a modern framework for making sure it continues to strengthen and secure its gold standard for medical product review.

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About The Authors

Scott Gottlieb’s picture

Scott Gottlieb

Scott Gottlieb, M.D., is the commissioner of the U.S. Food and Drug Administration.

Jeffrey Shuren’s picture

Jeffrey Shuren

Jeffrey Shuren is the director of the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health. Shuren has held various policy and planning positions within FDA from 1998 to 2009, including acting deputy commissioner for policy, planning, and budget; associate commissioner for policy and planning; special counsel to the principal deputy commissioner; assistant commissioner for policy; and medical officer in the Office of Policy. Shuren received his bachelor’s and doctor of medicine degrees in medical education from Northwestern University under its Honors Program.