In FDA docket submission, survey of 510(k) users guides recommendations for creating a more predictable and consistent medical device review process
Authors of the largest survey to date on the effectiveness of the premarket notification (510(k)) medical device review process at the U.S. Food and Drug Administration (FDA) have submitted an official comment and analysis to the agency, comparing their survey findings to those of the recent Institute of Medicine committee report about the 510(k) process.
Funded by the Institute for Health Technology Studies (InHealth), the survey found that within the past three years, 76 percent of survey respondents’companies chose to bring a specific device to market first outside of the United States. Their reasons? One in five (22%) blame the high cost of conducting clinical trials in the United States. Another 14 percent cite quicker and easier regulatory processes outside of the United States. Nearly all of the remaining companies that choose to market first outside of the United States say they do so because of unpredictable 510(k) requirements.
John Linehan, PhD, a professor of bioengineering at Northwestern University and the study’s lead author, surveyed more than 350 professionals from small, medium, and large companies, all actively engaged in medical device development and closely involved in a recent 510(k) submission. His comments to FDA are based on the survey findings and directly compare IOM’s findings about the 510(k) process with survey data on the same topics.
“In spite of the IOM recommendation that FDA should abandon the 510(k) process, the results of this survey show that there is wide agreement among many experts on 510(k) issues about basic changes that could make this process work better, and help America retain its position as the global leader in new medical technologies," said Martyn Howgill, executive director of InHealth. “The real question is exactly what FDA can and will do with this feedback.”
The survey findings both support and differ from the IOM findings, and offer additional insight and data that may be useful to policymakers and FDA as priorities are set. Some of the key comparative findings by category include:
- Device Classification and Premarket Review
While the IOM report found the 510(k) process to be more “economical, faster, and less burdensome to industry than the premarket approval application,” survey respondents found that increased testing requirements have made the average time from submission to approval effectively the same for the two processes. As a result, especially for smaller companies, more are choosing to bring their products to market outside the U.S.
- FDA Infrastructure
Survey respondents agree with the IOM findings that there is simply not enough staff at FDA to manage these applications in a timely manner, and suggest that insufficient training and expertise among the staff who are there is leading to repeated – and costly – requests for information already provided. Respondents further submit that inconsistencies and unpredictability in the approval process may be due, in part, to staff turnover and varying levels of expertise from reviewer to reviewer. Senior staff at FDA with longer histories of working with industry were viewed much more favorably.
Lack of consistent or clear interpretation at FDA of intended use and indications for use is problematic according to both the IOM panel and industry survey respondents. A fuller understanding of these two terms would improve the efficiency of the process for both device companies and FDA reviewers.
- Evidence Supporting 510(k) Submissions
The IOM panel and the survey respondents agree that FDA’s determination of need for pre-clinical and clinical data is inconsistent, and this process has changed the most over the past three years in comparison with other types of requirements. The survey further revealed that guidance documents issued by FDA are insufficient to help companies navigate the process, and don’t exist at all for many types of devices. Both situations pose difficulties for manufacturers.
- De Novo Premarket Review
The study confirms the IOM finding that the De Novo review process is underutilized due to a number of factors, including lack of clarity in the process and undefined timelines. Industry finds the process further complicated and undesirable due to a perception that FDA staff discourage these applications.
- Innovation and the Clearance Process
The regulatory environment is widely cited as the number-one factor in a company’s decision whether to develop a new product, according to the survey. The study authors suggest a slightly altered definition of innovation to that used in the IOM report, and cite the length of submission review times as a strong disincentive to innovate, especially for smaller companies.
- The Medical Device Ecosystem
Lack of predictability in the 510(k) process is uniformly viewed as a barrier to venture capital investment in companies seeking approvals, and may be leading to companies opting for non-U.S. avenues to get their products to market. Predictability is further cited in the survey as the most critical metric for evaluating the efficacy of any changes to the 510(k) system, followed by ‘appropriate alignment of device risk and review intensity.’
Rather than accepting the IOM recommendation to replace the 510(k) process, FDA has indicated ongoing willingness to explore reforms that would make the process more responsive to the increasing complexity of medical devices. Earlier this week, the agency announced proposed revisions to the De Novo 510(k) clearance process, with changes broadly matching industry recommendations.
Launched in 2004, the Institute for Health Technology Studies (InHealth) is a nonprofit research and educational organization supporting independent analyses of the social and economic effects of diagnostic and therapeutic medical devices. For more information, visit inhealth.org.