The U.S. Food and Drug Administration (FDA)’s Commissioner, Dr. Scott Gottlieb, and the Director of the FDA’s Center for Devices and Radiological Health (CDRH), Dr. Jeff Shuren, recently announced that the FDA is continuing to explore ways to modernize the 510(k) program. The 510(k) program is one of the means by which the FDA evaluates new medical devices coming to the market. Currently, the 510(k) program is used for the clearance of low/moderate risk devices (Class I or Class II) that can be demonstrated to be “substantially equivalent” to a device already on the market (referred to as a “predicate device”). According to the announcement, the increasingly complex nature of the new generation of medical devices has made modernization of the 510(k) clearance pathway necessary. The two main thrusts of the announcement are to drive innovators toward using (1) “more modern predicate devices” or (2)”objective performance criteria” when bringing new devices to patients.
Reliance on More Modern Predicate Devices
One of the more significant potential changes announced is promotion of the use of “more recent predicates.” According to the FDA, many recently cleared devices rely on predicate devices that were originally cleared a decade ago or more. According to the agency, new device risks and benefits should be compared with predicate devices that incorporate technology that is more modern. Thus, a focus of the recent announcement is in encouraging the use of more recent predicates for comparison with new devices. The FDA stresses, however, that this change does not imply that previously cleared devices that rely on older predicates are unsafe. The specifics of what will constitute an “acceptable” more “modern” predicate device have not yet been described. Furthermore, the FDA intends to retire “outdated predicates,” but the specifics of these have not been provided.
Objective Performance Criteria
According to the announcement, in early 2019, the FDA intends to release guidance establishing an alternative 510(k) pathway based on objective safety and performance criteria rather than reliance on a predicate device. The FDA envisions this as the primary pathway for devices eligible for 510(k) review. Under this approach, “Manufacturers would be able to demonstrate that their products meet or exceed objective safety and performance criteria that are based on modern technological principles.” The announcement also noted that Congressional approval might be necessary to implement some of the proposals outlined.
What Impact Will These Changes Have?
According to Drs. Gottlieb and Shuren, the CDRH has leveraged a risk-based paradigm to develop a “forward-leaning regulatory policy that meets our gold standard for safety and effectiveness.” One of the recent policy shifts includes promoting the use of real-world evidence in regulatory decision-making. Others include updating the “De-Novo pathway” for low- to moderate-risk novel devices, and using objective criteria to serve as a predicate for future clearances. The FDA also expresses interest in building a national patient safety net. Regulatory approaches for digital health products and in vitro diagnostics are also on the FDA’s agenda, as is a premarket review path for breakthrough products.
The above changes will significantly alter the data required and the approach to bringing new medical devices to market. With newer technology and safety standards being encouraged, and, potentially, required for predicate devices, manufacturers will need to ensure that they are able to generate the appropriate evidence for clearance.
How Exponent Can Help
In addition to evaluating the impact of the changes in the evolving 510(k) program on manufacturers’ future devices, Exponent’s consultants can provide expansive technical and regulatory expertise in navigating the impacts and changes that these announcements will have on medical device manufacturers, including the following:
- Pre and post market device performance and safety testing
- Identification of new/modern technology standards for device evaluation
- Evaluation of candidate objective safety and performance criteria for use with innovative technologies
- Assistance with identifying the appropriate regulatory strategy for new technologies
- Identification and analysis of real-world data to understand device performance and safety, and to support submission and post market surveillance strategies
- Analysis and interpretation of clinical data and real-world data on predicate devices, including data from registries
- Technical support for regulatory submissions and compliance
- Failure analysis as part of complaint or recall investigations