FDA Announces Plans to Revamp 510(k) Clearance PathwayNovember 29, 2018
On November 26, 2018, the Food and Drug Administration (FDA) announced plans for modernizing its 510(k) clearance pathway, which dates back to 1976 and remains the agency’s main method for reviewing medical devices.
The announcement came a day after the International Consortium of Investigative Journalists (ICIJ) published a report critical of how health authorities around the world regulate implantable medical devices.
The FDA requires a 510(k) premarket submission to demonstrate that a new device is substantially equivalent to an older “predicate device” already on the market. The agency continues to believe in this process, but recognizes that the “framework needs to be modernized to reflect advances in technology, safety, and the capabilities of a new generation of medical devices.” To that end, the agency will propose measures to shorten the age gap between devices and their predicates, noting that some devices on the market have predicates that are decades old.
Plans to update the 510(k) process are part of an overall FDA strategy to improve the safety of currently marketed medical devices and stimulate innovation of new safer, more effective devices that address unmet medical needs. This strategy was introduced in April, when the FDA released its Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health. The plan outlines key actions that the agency will take in the following areas:
- Establish a robust medical device patient safety net in the United States.
- Explore regulatory options to streamline and modernize timely implementation of postmarket mitigations.
- Spur innovation towards safer medical devices.
- Advance medical device cybersecurity.
- Integrate the Center for Devices and Radiological Health’s premarket and postmarket offices and activities to advance the use of a Total Product Life Cycle (TPLC) approach to device safety.
The FDA will continue to update the public on the status of the Medical Device Safety Action Plan and describe further measures being taken to promote patient safety.
Food and Drug Administration (FDA).
Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices [news release]. November 26, 2018. Available at: click here. Accessed November 28, 2018.