Medical Device Daily Managing Editor

SAN FRANCISCO —− Attendees who stuck around until the end of Wednesday were blessed with a real treat, a chance to pick the brain of the head of the Center for Devices and Regulatory Health (CDRH), Jeff Shuren, MD. While there was no actual cannibalism involved, entrepreneurs certainly hungered to hear some good news from someone so closely involved with regulatory policy from Washington.

Shuren noted that two FDA working groups issued 55 recommendations in August 2010 to improve the most common path to market for medical devices, the 510(k) process. That list was whittled down in January 2011 to a list of 25 recommendations that it planned to act on immediately. Key actions included: streamlining the de novo review process for certain innovative, lower-risk medical devices; clarifying when clinical data should be submitted in a premarket submission, guidance that will increase the efficiency and transparency of the review process; and establishing a new Center Science Council of senior FDA experts to assure timely and consistent science-based decision making.

"The bottom line is we identified some of the biggest problems were on the FDA side," not on the industry. We had not done as good a job as we should have in managing the program," Shuren said.

One of the biggest problems that he said they identified was insufficient management oversight, at times asking for unnecessary or inconsistent data requests. At the same time, he noted that the workload at CDRH had gone up "even in spite of resources going up and user fees." That was more than what the people were able to handle along with a high turnover rate at the agency.

Shuren said that the signs of trouble really started back in 2002. "The canary in the coal mine were things like requests for additional information on the 510(k)."

Shuren asserted that 2011 was the year CDRH really made inroads in changing how they went about their business. He said many of those things aren't going to fully kick in until next year, but the processes are finally in motion and many big policy changes will get finalized this year.

While he is proud of some of CDRH's initiatives, Shuren acknowledged that the agency "still has a long way to go, but some of the early signs are positive."

Shuren stressed that the high turnover rate at CDRH is a big issue. He noted that their are not enough managers at the agency at this time. "The ratio of frontline managers to staff is around 1 to 14 to upwards of 1 to 25 and 1 to 27" at the various CDRH offices. "That's a prescription for disaster," he said. He added that just over half of these frontline managers have less than three years of experience. He also noted that about 40% of CDRH's reviewers have about four years of experience, and it takes about four years for these people to gain the needed expertise. "Those numbers have got to get turned around."

According to Shuren safety and effectiveness to not have to get in the way of ground-breaking innovation. "The alignment of safety and effectiveness and innovation doesn't have to be polar opposites, they actually can be aligned and complimentary."

Trying to find a way to align these various ideals is what lead to the Medical Device Innovation Initiative in February 2011 (Medical Device Daily, Feb. 9, 2011), Shuren said.

The nuts and bolts of the innovation program is that CDRH assigns a case manager for each product to be fast tracked and establishes a primary review group to help each application along. Within 120 days from acceptance of such an application, CDRH reviewers are charged with developing a memorandum that describes a road map for assessment and review of the application.

Shuren said the program was initially cobbled together "with spit and chewing gum." The first application to go through the expedited review mechanism was sponsored by the Defense Advanced Research Projects Agency (DARPA), part of the Department of Defense, which is working on an artificial hand and lower arm that closely replicates the functionality of the human hand, but which requires that a processor chip be implanted in the human brain in order to tie the device into the user's central nervous system.

What was different about this new initiative as it related specifically to the DARPA project, Shuren said, was the level of early engagement between the developers and CDRH so that the agency could really understand the product "and try to lay out a pathway early on to the extent that we could." Even more critical in the process, he said, was the ability to see early on if there were going to be any unaddressed scientific issues to deal with. "Sometimes the lack of predictability isn't about the regulatory issues per se, it's about [having] the right tools to assess an emerging technology."

Shuren mentioned the need for a "culture change" at CDRH, this is particularly important he said, for making the PMA application process more effective for industry. Part of this also involves understanding patient tolerance to risk. "As I've said to my staff, when it is done, and you put [a product] out on the market, that device isn't about you, it's about patients. What are the risks [patients] are willing to tolerate?"

One thing that Shuren said should encourage companies is that CDRH needs to do a better job of understanding that first generation products are not going to be perfect, and that some technology needs to be given a chance to evolve.

Pouncing on that, one questioner from the audience wondered if perhaps CDRH should focus on safety exclusively and let CMS deal with efficacy. This, the questioner said, might make it easier to get a next generation product to market much quicker.

Shuren said, essentially what the question boiled down to was whether or not the U.S. would adopt a European style of regulatory approval. "The answer is no," he said and the reason is "it would significantly change your reimbursement situation." He noted that currently, "the approval of the FDA actually carries significant weight." He said the agency doesn't want to "lower the bar for marketing." He added that one key difference between medical device regulations in the U.S. compared to in Europe is that in the U.S. a device has to be safe and effective. In Europe, a device has to be safe and it has to perform, which is not exactly the same as being effective.

Shuren acknowledged that "culture change is hard." One way that this can happen quicker at CDRH, he noted, is to repair the deteriorating relationship between the FDA and industry. "I think if we're also going to drive change, it's not just what we do at the FDA. I think it comes from industry and others to actually be supportive of those changes, and start changing the dialogue that they're having with the folks at the center, that could have a big impact on speeding up this culture change."

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