FDA Announces Plans to Modernize 510(k) Program
November 26, 2018—FDA Commissioner Scott Gottlieb, MD, and Jeff Shuren, MD, Director of the FDA's Center for Devices and Radiological Health (CDRH), announced proposed changes intended to modernize the 510(k) clearance pathway to keep pace with the increasing complexity of rapidly evolving technology.
According to the FDA statement, the proposed framework aims to efficiently advance beneficial technology to patients while solidifying FDA’s gold standard for safety. In addition to modernizing the 510(k) pathway, the FDA seeks to promote greater transparency and postmarket surveillance. The full statement is available online here.
According to FDA, new medical devices that come to market under the 510(k) pathway should, where appropriate, either account for advances in technology or demonstrate that they meet more modern safety and performance criteria. At the same time, FDA will pursue additional actions that will allow it to retire outdated predicates, especially in cases where safer or more effective technology has emerged.
In the statement, Dr. Gottlieb and Dr. Shuren explained, "Advances in material science, digital health, three-dimensional printing, and other technologies continue to drive an unparalleled period of invention in medical devices. It’s vital that the FDA’s regulatory approach continues to evolve and modernize to safely and efficiently advance these opportunities. Not only must we keep pace with this complexity and innovation, but we must also stay ahead of the new and evolving risks that sometimes accompany this progress."
Also on November 26, FDA announced new steps and proposed actions to substantially build on the Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health, which was issued in April for public comments. The agency will seek additional feedback on whether it should make public those devices or those manufacturers who make technologies that rely on predicates that are more than 10 years old, whether other criteria should inform its point of reference, and whether there are other actions that should be taken to promote the use of more modern predicates.
The new modern framework is a direct and transparent approach to demonstrating the safety and effectiveness of low-risk to moderate-risk devices. It is an alternative pathway to substantial equivalence that will provide more direct evidence of the safety and performance of a device and better information for patients and providers to make well-informed health care decisions. This new approach may also drive greater market competition to develop safer devices, stated the FDA.
These changes are being proposed by the FDA after accounting for all of the improvements to the 510(k) review process in recent years. The agency has posted a performance report, which highlights some of the key achievements of the past decade, including the measures taken to increase the predictability and transparency of the 510(k) review process. These efforts include more than 50 final guidance documents on important medical device policy issues that the FDA has issued since 2009.
Recently, FDA described the progress that has been made to build and launch the National Evaluation System for Health Technology. They have also discussed the plans that are underway to focus on women’s health devices by strengthening and leveraging the Women’s Health Technologies Strategically Coordinated Registry Network and to specifically focus on active surveillance.
As a result of its 510(k) policy proposals, FDA believes that more devices will use the De Novo pathway, which permits a robust evaluation of novel devices and allows the FDA to establish special controls for devices of the same type.
The FDA will shortly issue a proposed rule clarifying procedures and requirements for submissions of De Novo requests, further advancing its efforts to establish a regulatory framework that sets clear standards, expectations, and processes for De Novo classification as a way to continue to modernize the 510(k) process. Some of these proposals may require additional support from Congress, advised the FDA.
Dr. Gottlieb and Dr. Shuren concluded, "We’re seizing the chance to make a generational change in the framework for 510(k) reviews where appropriate—one that advances its best features while making sure it keeps pace with modern innovation. In the coming weeks, we’ll provide additional updates on the status of our Medical Device Safety Action Plan and describe further steps we’re taking to promote patient safety. We’re proud of the work CDRH staff is doing to make sure that the devices we regulate are safe. We’ll continue to take new actions to strengthen the device program for the years to come."