FDA Mulls Harmonized Device Review System: Shuren
CDRH director Jeffrey Shuren says FDA and other international regulatory agencies are considering how to develop a harmonized premarket review system. Providing a Center update at the Alliance for a Stronger FDA in Washington, DC 9/6, Shuren said the harmonized review would be modeled after the Medical Device Single Audit Program, which is intended to allow recognized auditing organizations to conduct a single audit of a medical device manufacturer that will satisfy the requirements of the pilot program participant.
Shuren said developing such a review program will be much more complicated than the inspection program, but it is worth the effort “to see if that type of system can be replicated on the review side.” Regulators are already putting some of the pieces in place, such as common expectations for core competencies and training of reviewers. Also, he said FDA will think about other changes needed to the system. One is for moderate- to low-risk devices under the 510(k) program and a “voluntary opportunity to rely on safety and performance principles rather than the substantial effectiveness approach,” he said. “The reason is that other countries use it and it can actually be a better evaluation in some cases and cleaner to demonstrate that where there are well established principles.”
Another review change could implement a “progressive approval pathway” to market for some higher risk and innovative lower-risk devices which could go to market on a safety and performance standard, but to stay on the market would have to also demonstrate reasonable assurance of safety and effectiveness, Shuren said. “It would be an outright recognition that the value for patients in some cases will be greater to let the product on the market with a good understanding of the benefits and risks, yet not exactly to the reasonable assurance of safety and effectiveness standard, but it would be mandated to get that data postmarket.” He said this is a big challenge because it is hard to get patients to enroll in postmarket trials and the data requirements may fit into the agency’s real world data model instead.
With real world evidence (RWE), Shuren said the agency gets data all the time on what happens to patients when they use medical devices, “but we dont make great use of it. And yet that is the place where we can truly understand the real impact on patients.” The agency has high hopes with RWE and it has worked $30 million from user fees to fund a National Evaluation System for Health Technology (NEST) to conduct a pilot to establish its value. Under NEST, active surveillance is a key feature to drive down time and cost and increase value to RWE to meet the needs of the medical device ecosystem stakeholders through a “market-driven collective buying power approach,” he said. But there are challenges to overcome, such as standardizing definitions, assuring core standardized data sets, data quality and systems that don’t talk to each other.
Next, FDA plans to select a NEST coordinating center which will receive an initial $3 million to get it up and running in next few months, since user fee funds for it won’t begin until 2018, Shuren said. “We are also moving forward to establish data use agreements with a variety of different real world evidence owners, and we will make these available to NEST to move the ball forward.”
Shuren’s update also touched on assessing patient preferences and how CDRH can better engage patients on the design of clinical trials. If trials are “better designed around their needs and how they live their lives, we will see better enrollment in clinical studies and better information because we are moving towards how we assess people more in the real world than in the pristine clinical setting,” he said. More companies are approaching the Center on how to use patient-preference information, and patient groups are trying to help out as well, he said. The new user fee agreement will fund a program on patient engagement to advance the concept.
Additionally, Shuren said advancing a culture of quality is a top priority. He observed that on the industry side, “we don't have competition around quality. When buying a car you get all kinds of ratings, but not with medical devices. So, we are working with industry and others about how to set up that kind of marketplace, and the right metrics that are meaningful to companies, FDA, users and purchasers.” He thinks quality transparency could also help companies when they are considering the acquisition of another firm. “So often one of the problems we see is that you merge with another company, and you didn’t fully understand what was going on with that company and now we see all these problems in manufacturing quality that take a while to work through,” he said. “How much better would it be if we had more transparency around that company or an incentive to demonstrate you do a good job before getting purchased?”