Dr. Jeffrey Shuren, head of the FDA’s medical device arm, said a Northwestern University survey on the 510(k) clearance program “validates actions we are already taking” to improve the regulatory path for almost all medical devices.
“These efforts may not grab headlines, but they represent true actions we’re taking to promote innovation and protect the public health,” Shuren told an audience in Washington, D.C. this morning following a presentation of the survey results. “The 510(k) program has to adjust, but it has to adjust properly.”
Sponsored by the non-profit Institute for Health Technology Studies, the online poll of 356 medical device development experts found that two-thirds of small medical device and diagnostic firms look to Europe for their first regulatory clearances. Nearly all of the respondents cited “the predictability of regulatory requirements is a crucial factor in deciding whether to invest in developing a new product,” according to a press release.
“Large and small companies reported that unclear guidelines, inconsistent implementation, and lead reviewer turnover are contributing to increasing unpredictability of the process,” according to the release. “Only 8 percent of survey respondents believe FDA’s 510(k) product review process is the most predictable regulatory system, as compared with roughly two-thirds of respondents who stated that Europe’s CE marking process is the most predictable.”
Uncertainty about the 510(k) process, by which the vast majority of medical devices are cleared for the U.S. market, was the leading factor in pushing new device introductions overseas, according to the survey. Three-quarters of those polled found that the preparation requirements for a 510(k) submission were “uncertain or unclear” and 72 percent said requests from FDA reviewers for more information fell outside the requirements detailed in the watchdog agency’s guidance documents. Nearly 60 percent reported that no guidance documents existed for their devices.
Turnover among the FDA’s cadre of reviewers was also a concern, with 14 percent reporting changes in the lead FDA reviewer for their submission. And the financial impact of FDA requests had “a significant impact” on financial resources for more than two-thirds of all respondents.
Although he noted that the survey included questions that elicited purely subjective responses, “predictability is the most important factor,” Shuren said.
“While this survey is informative about the experiences and perception of this group of respondents, we should be cautious about the actual percentages,” he said. “With those limits in mind, the survey does highlight some informative findings and opportunities for FDA and industry to make improvements.”
The Center for Devices & Radiological Health Shuren oversees is hampered by a couple of factors: The ever-increasing complexity of medical technology and chronic turnover among its cadre of reviewers. Dealing with the latter is especially important to improving the 510(k) protocol, he said.
“It’s critical that we reduce the unacceptably high staff turnover at CDRH,” he said, adding that plans afoot at the center include beefing up its ability to issue guidance documents — the lack of which is a key industry concern.
“A significant increase in guidance production won occur until we have the resources to establish a group of technical writers” to free reviewers and scientists to do what they do best, Shuren said. The CDRH plans to issue seven new sets of guidance this year, he added.
But that said, the industry can do a better job on several fronts, Shuren noted.
“Small companies need more help to succeed in bringing their products to market, yet they are also the most resistant to suggestions,” he said. “Less than a quarter of companies that come to meet with us follow the advice they receive.”
The quality of 510(k) applications could also use some work, according to the CDRH chief, stressing the importance of his center setting clear expectations.
“We have to make sure we are getting high-quality submissions,” Shuren said, detailing an internal review of a batch of applications that showed that “more than half of the 510(k) submissions had quality problems, such as failing to provide any performance data.”
“Poor-quality submissions divert time and resources from the review of other devices,” he said.
Addressing another persistent industry complaint — that the agency isn’t clear about what data needs to be collected to satisfy the process, Shuren said agency requests for more data are sometimes driven by information the applicant might not be privy to. And the pace of innovation in the U.S. device market means the FDA must continually update its standards to account for the new technology.
“We are seeing more and more sophisticated devices coming on the market. We sometimes do ask for more data than we might have previously, [but] good data is critical for understanding problems, when they exist, and developing solutions.”