Ongoing media attention concerning medical device safety and quality is causing many to question whether there is a need to reform the 510(k) clearance process. Nearly 20% of current 510(k)s are cleared based on predicates that are more than 10 years old, according to the FDA. In a recent statement, the FDA announced that it will be “focusing on new policy efforts that we plan to advance to help the 510(k) program keep pace with innovation, promote modern patient care and match our evolving understanding of benefits and risks. Our new plans are aimed at continuing to ensure that new and existing devices meet our gold standard for safety and effectiveness as technology rapidly advances.”
Dr. Scott Gottlieb, FDA Commissioner was featured on CNBC on November 26, 2018. He addressed several issues the FDA is monitoring in regard to medical devices. Concerning the new rules, he stated, “The FDA is pursuing new efforts to ensure device safety, and develop active and post-market surveillance in the marketplace. The FDA and the U.S. should be among the first in the world to spot a ‘safety’ signal among world regulators.”
The FDA wants to significantly modernize the device approval process. Many devices come to market by comparing to other devices, using a predicate that may be decades old. Efforts will be made to make it ‘easier’ for companies to establish new predicates for new standards. Some of the older predicates that have been used for approval will be retired as sometimes they are no longer on the market.
In 1976, Congress considered the vast diversity of devices that would become subject to the FDA’s regulatory oversight and established many of the predicate devices that served as the basis for 510(k) clearances over the last 40 years. Now, FDA plans to “push the market to better technology and capabilities by advancing the predicates and always looking ‘forward’.” The complement of predicates that companies are using as the basis for approvals are constantly incorporating new and better technologies.
When asked about the risk of dealing with predicates that may not have decades of history, Gottlieb said, “The newer devices have better safety and technology built in. The concerns will be on the side of the industry, concerns that standards may be raised for approval, because it may have been easier to compare to older products. Comparing to new technology with more capabilities, you will be coming to market with a better label, a newer product comparison, making the product more competitive. It may be easier to bridge to a newer technology than an older one.“
Medical device safety concerns have been escalating in the public eye. In July, Netflix released a documentary The Bleeding Edge, examining the patient experience and adverse effects of a contraceptive technology. Other adversely impacted patient stories have emerged around devices like breast implants, transvaginal surgical meshes and spinal fusion and bone stimulators, among others.
The FDA also recently announced that they are committing new resources to NEST, (National Evaluation System for Health Technology), advancing a more rapid build-out of a national surveillance system. NEST is intended to become a community-wide resource, and leverages a wide range of data systems. Patient registries, electronic medical records and Medicare claims are among the sources of clinical information that will be included. Another key component is the unique device identification (UDI) system. When medical devices are marked on their labels with a unique code, they can be used to track the device through its distribution and use in patients. Now numbering more than 1.5 million device records, public databases enable patients and health care providers to download information about devices, including patient reported problems, recalls and adverse events reported.
FDA stated it will seek public feedback on posting a list of predicates that are more than 10 years old on its website. They stated clearly that they “don’t believe devices that rely on old predicates are unsafe, or that older devices need to be removed from the market. However, we believe 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.”
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