On Monday, November 26th, FDA announced changes to modernize the 510(k) clearance pathway, which is the most common medical device submission and allows for the allows for the "clearance of low- to moderate-risk devices that are substantially equivalent to a device already on the market – otherwise known as a predicate device." The changes will help the Agency keep pace with evolving technology and reflect the advances in the safety and capabilities of a new generation of medical devices. The FDA believes that "new medical devices that come to market under the 510(k) pathway should either account for advances in technology or demonstrate that they meet more modern safety and performance criteria". The Agency plans to pursue actions that will retire outdated predicates, especially those in which new, safer, and more effective technology has already been created.
FDA still firmly believes in the merits of the 510(k) process, but explicitly stated that innovative advances in technology have forced the Agency to evolve and to anticipate upcoming technological changes.
Background of the 510(k) Pathway
The Medical Device Amendments of 1976 established three categories of medical devices: Class I, II, III. Each class is based upon the level of risk the device poses to the user.
Included in the amendment was the provision for the 510(k), which specified that if a new device was substantially equivalent (SE) to a device legally marketed in the US before May 28, 1976, it "could proceed to market with the same classification and controls".
To obtain substantial equivalence, the devices in question are not required to be identical. SE is established with respect to; "intended use, design, energy used or delivered, materials, performance, safety, effectiveness, labeling, biocompatibility, standards, and other applicable characteristics".
Current 510(k) Program Innovation
In 2017, FDA’s Center for Devices and Radiological Health (CDRH), cleared 3,173 devices through the 510(k) pathway, which accounted for 82% of all devices cleared or approved last year. In the recent past, CDRH has made efforts to improve the performance, predictability, efficiency, and safety of the 510(k) program. FDA believes that its recent announcement will continue to assist its efforts to encourage innovation, promote modern patient care, and match its evolving understanding of benefits and risks. The Agency states that the most impactful way to achieve its goal is to encourage innovators to rely on more modern predicate devices or objective performance criteria when seeking to bring new devices to patients.
CDHR is considering releasing an online list of cleared devices that demonstrate SE to predicate devices which are more than ten years old. In addition to bringing public awareness to these devices, FDA hopes it will drive sponsors to offer devices with the newest technology to patients. Before releasing this list, FDA plans to seek public feedback on whether it should release "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 it should take to promote the use of more modern predicates." The Agency does not believe devices that rely on old predicates are unsafe
The joint statement from FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D, Director of FDA’s CDRH, states that "nearly 20 percent of current 510(k)s are cleared based on a predicate that’s more than 10 years old". Dr. Gottlieb and Dr. Shuren note that this does not necessarily mean that the products are unsafe, nor does the Agency think that older devices should be removed from the market. However, the pair feels "that encouraging product developers to use more modern predicates would give patients and their doctors a choice among older and newer versions of a type of device, promote greater competition to adopt modern features that improve safety and performance, and help make sure that newer devices reflect more modern technology and standards that can improve patient care and outcomes. It would help the overall product environment continue to evolve in the direction toward more modern performance standards."
The devices reviewed through the 510(k) program are growing increasingly complex. They are smaller, more portable, and are more interconnected. Technology has changed the way healthcare providers and patients interact with devices, and all of this has prompted the need for guidance.
Planned Alternative Accelerated Pathway
In early 2019, FDA plans to finalize guidance establishing an alternative 510(k) pathway. This guidance will complement the new modernization overhaul for manufactures of well understood device types by allowing them to "rely on objective safety and performance criteria to demonstrate substantial equivalence" based on criteria set by the FDA. The goal is to finalize the pathway to "expand its use broadly across the 510(k) program and make it the primary pathway for devices eligible for 510(k) review." FDA plans to rename this approach the "Safety and Performance Based Pathway" to more accurately reflect the safety and performance of new medical device technology.
If finalized, the proposed changes to the 510(k) pathway will help the FDA keep up with modern technology. With these new innovations, the Agency’s top priority remains to assure the safety and effectiveness of devices for patient safety.
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