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10 Important Updates from FDA

The CDRH Townhall at The MedTech Conference provided key updates on several programs.

  • The goal for this year’s FDA Townhall at The MedTech Conference was to have more of an interactive session, Janet Trunzo, senior executive vice president, technology and regulatory affairs, AdvaMed, told the audience. Attendees were asked to pose their questions to the panel, which included Jeffrey Shuren, director of FDA's CDRH; Capt. Raquel Peat, PhD, director of the Office of Orthopedic Devices in CDRH, Suzanne Schwartz, MD MBA, deputy director, Office of Strategic Partnerships & Technology Innovation, CDRH; Michelle Tarver, director of Patient Science & Engagement at CDRH; and Bill Maisel, chief medical officer and director, Office of Product Evaluation and Quality at CDRH.

    Read on for a few updates from FDA as panelists answered audience questions.

    Image by Gerd Altmann from Pixabay
  • Breakthrough Devices Program
    “For folks who are interested in breakthrough . . . you lose nothing by being a breakthrough device,” Jeffrey Shuren, director of CDRH, told the audience in response to a question about whether or not to apply for a Breakthrough Device Designation. “It’s an opportunity for us to engage early and often and work through issues, so [there’s] nothing to be lost by doing it.”

    Shuren added that the “feedback has been so good that the number of designations for breakthrough devices has doubled each year for the past few years. This year just going into the beginning of September, not even the end of the fiscal year [we’ve had] 103 designations; the year before fiscal year, 55; year before that, 19; and year before that, 11.” It does “eat up” a lot of agency resources, he said, so they are “monitoring the resource implications, because what we will not do is disenfranchise anyone who has a product that is not a breakthrough device. . . .”

    In the Breakthrough Devices Program, companies will start having “deeper conversations” with FDA at early stages. “You may get feedback . . . that may help you in terms of whether you really are a breakthrough and if you are, making sure it’s a good submission coming in the door,” Shuren said.

    Image by Peggy und Marco Lachmann-Anke from Pixabay
  • Pre-Submission Meetings
    Companies also have the option for presubmission discussions by requesting a “pre-sub” meeting, which according to guidance could be “in-person or by teleconference as the submitter prefers.”

    When asked about the review cycle and the potential efficiencies gained during presubmission meetings, Bill Maisel, chief medical officer and director, Office of Product Evaluation and Quality at FDA CDRH, said that “We think it is advantageous for the review teams to understand your device [and] why you did the testing you did and the story of your device development so that when the submission comes in house, they understand your technology and are not spending weeks or months looking at paper and diagrams and trying to figure out how a device works.”

    Maisel added that “for me-too devices or devices that are very similar to technologies already on the market or other devices we have seen, the presubmission process becomes less critical. But certainly for breakthrough technologies or other devices that really are different or have features or modifications that are important, it is always advantageous to plan in your device development process a time to check in with the team and let them know about your device. The presubmission process can help prepare the team and make the review go much more easily. It also can help prepare companies for doing testing that they might need to do that might take weeks or months. So instead of sending in a submission and getting a deficiency letter that says you need to go do test A, B, and C, you could have found out that information perhaps months or even in some cases years earlier and completed that testing along the way.”

    Maisel also said that years ago, companies were “afraid” of coming in for a presubmission meeting. “Part of that was because we heard we moved the finish line between the presubmission and the actual submission. We try very hard and I think have done a very good job of standing by our advice. So, if you come in and have a presubmission and we give you feedback, we will stand by that feedback . . . unless something has changed—you’ve redesigned your device or there is important safety issues that have arisen that we didn’t know about at the time we gave our advice.” He said that the numbers reflect that “people find value in the presubmisison process—we’ve had an exponential increase in the number of presubmissions each year for 6 or 7 years in a row.”

    Image by Chief22880 from Pixabay
  • Payor Communication Task Force
    When asked about the Parallel Path Review and Payor Communication Task Force, Shuren said that “CMS has been a great partner.”

    “We put in place parallel review as a little bit initially of a toe-in-the-water process improvement,” he explained. “You can begin the national coverage determination process while that product is still under review at FDA. What I think is even more important to the program is the opportunity to meet with us and CMS in sort of a presubmission context before you’ve done a pivotal clinical trial to get our respective input and develop the most efficient clinical evidence generation strategy.” There haven’t been a lot of products to move through the program, he said, but the program has resulted in many more companies receiving advice from CMS, he said.

    Image by Thomas B. from Pixabay
  • International Medical Device Regulators Forum
    The International Medical Device Regulators Forum has “a work stream on clinical evaluation, and [one of] the topics . . . is the acceptance of clinical data generated in another country or jurisdiction,” said Shuren. “The nice thing that has come out of this we’ve seen some countries that have been a little bit more risk averse for leveraging data from outside their country starting to warm to the idea, particularly China.”

    A number of documents have come out or are coming out for public comment on cybersecurity, clinical evalution, and good regulatory review practices involving recognition of third parties for medical device review.

    “The next stage is how we as IMDRF are able to speak with one voice in important international voluntary consensus standard development organizations like ISO and IEC. One of the challenges we find with standards is that they may not be fit for purpose for us—they are not regulatory grade, particularly if they are not providing acceptance criteria methodology—it becomes a lot harder to use them,” Shuren said. “So, we are trying to have a stronger voice in those settings because we think if there are regulatory-grade standards we are more likely to recognize them as jurisdictions and that drives harmonization.”

    And while the efforts toward regulatory review practices have put together the building blocks for medical device single review program, “IMDRF has not blessed setting up such a program,” Shuren said. The work involving regulatory review practices should be wrapped up in about a year, and then “we as IMDRF would have some important decisions to make—are we going to move forward and establish a medical device single review program or not?”

    Image by OpenClipart-Vectors from Pixabay
  • Patient Science and Engagement Program
    “Our staff has been committed to engaging with patients,” said Michelle Tarver, director of Patient Science & Engagement at FDA CDRH. “Through that process we’ve learned a lot about how important to think about that voice, hear it, and incorporate it when it’s relevant to our regulatory decisions. . . . We’ve also committed to making sure that we integrated patient input where it was relevant in all of our decisions and we made that publicly transparent so that others could see how important that information was in that regulatory decision-making process.”

    She added that the Patient Science and Engagement Program is inspired by patients and driven science. “Our overarching goal is to understand the patient’s voice—not just hear but understand it and incorporate it into all regulatory activities where it is important.” She added that the effort includes a Patient Engagement Advisory Committee—the "only one like it at the agency"—comprised solely of patients, caregivers, and patient advocates. During its initial meeting in 2017, the group talked about “the importance of engaging patients as advisors in the design of clinical trials and the conduct of those trials as well as the relaying of information after the trials back to the patient community.” The draft guidance spells out the "importance and value that patients bring to the clinical trial design process," she said. She added that the agency welcomes comments on the draft.

    After an audience member asked how much FDA weighs patient-reported outcomes, Tarver said that “We are very committed to having quality and relevant patient-reported outcomes being included in clinical investigations, and we think the industry is as well,” she said. “We’ve seen in our submissions over 75% of our IDEs have patient-reported outcome measure as one of the endpoints.” She added that the agency is “also working internally to share with our staff the appropriate approaches to looking at patient-reported outcome measures.”

    Image by 圆 张 from Pixabay
  • Case for Quality
    "The MDIC [Medical Device Innovation Consortium] just put out a report talking about our experience, which I think from the companies has been very positive. For them it has been an opportunity to learn more about their own organizations and opportunities for improvement,” Shuren said. “We’ve been impressed as well.”

    The next step is to create a formal voluntary improvement program under Case for Quality. “As we build this out and put governance in place . . . we are also looking at what other things we may do to appropriately leverage the program and to incentivize participation. Becasue if we have high confidence in the capabilities of the companies, that allows us—particularly for high performers—to focus more effort on the people who need more help from us,” Shuren said. He added that the voluntary improvement program "is not in lieu of quality system requirements."

    Image by Gerd Altmann from Pixabay
  • Software
    The panel was also asked about software guidance.

    “Today, if you are dealing with technology—SaMD—we have been fairly public that we do not think the currently regulatory framework—that 40-plus-year-old framework that has only been tweaked over the years—is fit for purpose,” he said. “We are test driving some different approaches, like precertification. We are sort of anticipating that as we kind of work this through and hopefully as an ecosystem figure out what that framework should look like and what provides the right safeguards to protect patients but also facilitates responsible innovation, we are likely going to need to go back to Congress. . . . At that point we may be looking other regulations and guidances coming under a new framework.” (There are some projects underway that FDA did commit to under MDUFA and 21st Century Cures Act, he added.)

    Regarding precertification, Shuren acknowledged that it is a pilot program with 9 participants, “but we have been very clear that if you are similarly situated, and there are similar approaches that would make sense to do with you, then we would go ahead and do that. We are not changing the regulatory standard to market . . . but we are looking to do business differently if it is appropriate to do so and we will apply the same to similarly situated companies and technologies. . . . But you gotta come and talk to us.”

    Image by Werner Moser from Pixabay
  • ISO 13485
    When asked about ISO 13485:2016 Medical devices—Quality management systems—Requirements for regulatory purposes, Shuren said that “essentially the standard will for the most part replace QSR.” He added that industry might “see some add-ons” as the agency builds it out. “Today 13485 the 2016 version matches up with what we do [by] about 95%. . . . In some areas it is a little stronger than what we have, such as in risk management.

    “And so what that will mean for a company—it’s not that you suddenly won’t get an FDA inspection . . . it is just that the standard by which we will go ahead and assess wouldn’t be QSR but the ISO standard with maybe a little plus.” The agency will need to retrain inspectors and make some changes in terms of documentation and other areas, but it will give companies time on the transition, he said. “We are looking to make this as least burdensome as possible,” he added.

    Image by Shahid Abdullah from Pixabay
  • National Evaluation System for Health Technology
    National Evaluation System for Health Technology (NEST) has “representation from stakeholder communities in the medical device ecosystem,” such as patients, providers, governments, industry, payers, explained Shuren.

    “It is rather unique because there are a lot of real-world data efforts that are going on in the country—there is no effort that we are aware of that has that full sort of spectrum and perspective that comes from all the stakeholder communities involved—it really is something of, by, and for the ecosystem. So anticipate seeing a lot more coming out on this from NEST.”

    When asked about the communities, “we don’t establish them, develop, manage, or monitor them,” explained Tarver. “We are members.”

    Image by Tumisu from Pixabay
  • The Future
    "We are going to believe it or not have to start thinking about MDUFA 5, soon, next year . . . we’ll start with a public meeting," Shuren said. “This go around, think about where do we want to be as an ecosystem at the end of MDUFA 5 maybe at the end MDUFA 6. Let’s really think where we should be—what’s is going to be the best place ultimately for patients,” he said. “Patients will get to weigh in on that as well. And then we can back up and start to think about . . .what do we need to do under the user fee program to support that and things outside the user fee program.”

    He also acknowledged industry's innovation and the complexity of science and technology. “That means it is moving a lot faster than the regulatory framework put in place so many years ago. We've got to rethink this.” SaMD is not the only “space” where this is the case, he added.

    “Should we really have cookie cutter pathways, or should we have building blocks—something we call regulatory 'Legos' where we have enough tools there to put it together to best meet those new technologies that are going to come both today and in the future so we don’t have to keep going back to Congress to go make changes?” he asked.

    Shuren wrapped up by saying he would like to have statements that U.S. FDA is the “gold standard” removed from the lexicon. “If we are going to be moving as truly a global community and we going to advance global harmonization, and we see this as the next big horizon we have to be going after, then we cannot be talking about gold standards. We have to recognize there are a lot of innovative things going on in other countries, there are experts sitting in other countries, there’s data sitting in other countries. We have to really think about we’re members of a global community and not about everything with the U.S. first but rather let’s focus on international citizens having an international system. And maybe that is one of the places we should be going as we look to MDUFA 5.”

    Image by Gerd Altmann from Pixabay
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