CDRH’s vision is for U.S. patients to have access to safe and effective medical devices before other countries.
FDA Wants to Be First in the World to Approve Devices
“We want to get new technology to patients as quickly as possible. First in the world is a good measure for that,” saysCDRH director Jeffrey Shuren, MD.
Speaking Tuesday at the Transcatheter Cardiovascular Therapeutics conference in San Francisco. Shuren stressed that the agency still has the same standards for ensuring the safety and efficacy of medical devices, but that it is working hard on improving its medical device ecosystem. “This is not a competition. We are not in a race with Europe or anywhere else,” he said. “But if there is good technology, we do want to have it come out first.”
That may seem like an especially ambitious goal given the agency’s regulatory standards, which are some of the strictest in the world. This often translates into a need for device sponsors to generate considerable evidence in order to get a device approved. That in turn leads to high costs and and years of work on the part device companies. A significant number of medical device developers have either fled the United States or have decided to not consider the U.S. as part of their initial product launch strategy. “So for us the solution is: can we sufficiently reduce the time and cost to bring product to the market such that innovators view our market favorably without compromising our standard of reasonable safety and efficacy?” Shuren said.
Progress in 2014 and 2015
Shuren stated that the agency has already made significant progress in 2014 and 2015, when it identified significant regulatory cost and time drivers, and worked to address them. For instance, CDRH has worked with industry to make clinical trials less expensive and more efficient, shifting some data collection from pre-market to post-market, and providing “excellent customer service.” If the agency can better understand the needs of industry, they are more likely be able to make better regulatory decisions and, quite possibly, help them identify a more streamlined pathway to market.
The agency has made progress in approving clinical trials related for devices that have won an investigational device exemption. It has also increased the number of early feasibility studies done in this United States. “If we know we can get it done early, we are likely to see it come to the market early, and clinicians get early experience with it as well,” Shuren said. FDA increased the volume of such early studies 50% in the first nine months of 2015. “And, not only that, out rate of approvals has skyrocketed,” he added.
In addition, FDA is working to enhance the quality of medical device clinical trials while making them more efficient to run. “There are too many clinical trials collecting lots of information we don’t ask for. Some of it may be for payers, but a lot of it isn’t for either [CDRH or payers] and it has created a lot of complexity and greater time,” Shuren said.
FDA is also looking at using modeling to reduce the size of some clinical trials. “If you model out what you think the end is going to be, and we validate that, you can start the trial and have a shorter cutoff if that matches up with the model; you don’t have to do the longer study,” Shuren said. “And we have a mock submission that is going through FDA review right now.”
Many of the FDA’s advances can be traced back to the work of an organization known as the Medical Device Innovation Consortium: the first public-private partnership that is focused on advancing regulatory science for medical devices. “It is not the science of making technologies, it is the science of understanding what they do,” Shuren said. The consortium has already helped develop tools to help lead to faster, safer, and more efficient regulatory processes.
In addition, CDRH is looking to reduce the regulatory burden for many device classes. “One of our efforts is to review every type of high risk device subject to a PMA, and see if, based upon the science today, if there are data that we can shift from pre-market to post market or can we down classify,” Shuren said.
In the agency’s review of medical device types thus far, approximately 30% of device types reviewed were eligible for shift to down classification, which Shuren says translates into less burden for the device sponsor.
“We also dawn-classified 120 device types from Class II to Class I,” Shuren said. “There is a major effort to reset the landscape.”
Shuren also touted the agency’s Expedited Access Pathway Program for breakthrough medical devices. The agency has received 19 requests for this program so far.
Looking to the Future
One of the agency’s next initiatives is to have greater engagement with its customers—both with industry and with patients—especially the latter. “Our vision starts with patients. They are truly the focus of what we do. Our basic mission is basically improving the health and the quality of life of patients,” Shuren says. “We are working on understanding what are patients’ preferences and the benefits and risks they are willing to accept for a given cost. It is not just asking them. There is a science to it. In fact our work in this area helped lead to the first device-based approach to treat obesity since 2007.”
The agency is also looking to factor patient-reported outcomes into its approval decisions. “Along these lines, we have established a patient-engagement advisory committee. There are a panel of patients who get to make recommendations to the agency,” Shuren said.
In terms of premarket review, the agency is looking to build on the progress it has made in recent years. “In the 510(k) space, we’ve had some modest decrease in average total time to a decision. We still think we are making appropriate decisions and the backlog is going down,” Shuren said. “For PMAs, we have cut our average total time down by one third. This year may be the biggest year for PMA approvals in many, many years,” he added. “For de novos, we shaved off two years on the process.”
FDA’s leadership is hoping that other changes to streamline the healthcare system at large will also benefit the agency. “We have a lot of inefficiencies in our healthcare system, and as a result, we can’t make use of evidence that is generated routinely in healthcare. We have data that is siloed in systems that don’t talk to one another, and we have challenges with data quality and completeness,” he said. “We need to be able to harvest data from EHRs and registries and claims forms. If we do that, we can change our ecosystem.”
Shuren outlined a few challenges or uncertainties standing in its way. He is hoping the 21st Century Cures Legislation will be enacted, which will give more funding to the FDA. “If we don’t get the funding, we’ll have to shift dollars from what we are already doing,” he said. The congressional budget process is another hurdle. “God knows it is completely unpredictable, but I never know my budget in any given year.” In addition, the Medical Device User Fee Act IV negotiation process is another wild card.
In his summary, Shuren called for industry to be more involved in collaborating with CDRH. “We have great partners but we need more people to be engaged. Ultimately, we rise or fall together.”
Posted in Regulatory and Compliance by Brian Buntz on October 14, 2015
Shuren announced that the agency had made substantial progress in terms of its timelines of approving 510(k)s, PMAs, and de novos.
