CHI's Latest Report Shows Modest Improvement in FDA Medical Device Review Times

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Real Improvements Evident, Yet Still Areas of Concern

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The progress we’ve seen illustrates what can occur when industry, the FDA, Congress and patients work together. - CHI President & CEO Todd Gillenwater

California Healthcare Institute (CHI) today unveiled a report that provides a comprehensive overview of U.S. Food and Drug Administration (FDA) medical device review times. Working with the FDA, CHI examined a number of issues that directly impact medical device approvals, such as decision efficiency, process efficiency and outcomes, while also providing context on legislative regulations governing FDA medical device product review processes and procedures. CHI is a nonprofit, public policy research organization, representing leading California academic institutions, biotechnology, medical device, diagnostics and pharmaceutical firms.

Developed in collaboration with The Boston Consulting Group (BCG), the report is titled “Taking the Pulse of Medical Device Regulation & Innovation,” and takes a holistic look at specific benchmarks including review times for both Premarket Approvals (PMAs) and 510(k)s, review backlogs, overall approval rates, division branch performance and comparisons to EU timelines.

“The FDA is a critical linchpin in the medical technology innovation ecosystem,” said CHI President & CEO Todd Gillenwater. “We produced this report to be a productive tool to continue to drive forward and communicate the real improvements we’ve seen at the FDA, while also being constructive in pointing to areas where there is still more to be done. The progress we’ve seen illustrates what can occur when industry, the FDA, Congress and patients work together.”

CHI worked closely with Agency leadership in development of the report, during which the Center for Devices and Radiological Health (CDRH) Director Jeff Shuren, M.D., and his senior team spent considerable time providing answers about the data presented. The data is based upon submission cohorts, taking most recent submissions as a starting point, and assessing their fate in a forward looking manner. This provides a more accurate picture of review times because they are based on most recent progress, not biased by past performance.

Key Facts and Report Highlights:

  •     Data suggests that the PMA classes of 2011 and 2012 will show the best overall review-time performance of the device user fee era. 2013 shows even further improvement, however, it is premature to determine given the number of products still awaiting a decision.
  •     When comparing PMA submission trends at the FDA with those in Europe, we see that the 3-5 year lag between approvals in Europe and subsequent US approvals hasn’t improved during the user fee era, which began in 2002.
  •     After holding steady between 2000 and 2006, 510(k) clearance times lengthened dramatically, with review times in 2010 being 60 percent longer than in 2000. Even with some improvements over the past couple years, 510(k) review times continue to remain far higher, and processes are still viewed as less predictable, than during the pre-device user fee era.
  •     After climbing steadily since 2005 and peaking in 2010, the Agency’s 510(k) backlog has begun to improve – especially for those pending for more than 90 days. However, by nearly any measure, there is still much work to be done before the 510(k) process is considered back on track.
  •     Review divisions have varied markedly in meeting their PMA MDUFA performance goals. Similar variances exist across branches for 510(k) decisions. Encouragingly, the most recent years’ data shows a trend towards narrowing those gaps.

“The data in our report illustrates that Agency leadership has worked to get processes, internally and with industry, back on track,” said Gillenwater. “But there is more work still to be done to ensure device regulatory review processes are best directed towards the Agency’s twin goals: protecting patient safety and promoting patient health through timely approval of and access to innovative medical technologies. We look forward to continuing our work with the Agency and Congress towards those goals.”

Click here to view the full report on CHI’s website.
Click here to view PDF version of the report.

About CHI-California Healthcare Institute
CHI represents more than 275 leading biotechnology, medical device, diagnostics and pharmaceutical companies, and public and private academic biomedical research organizations. CHI’s mission is to advance biomedical research, investment and innovation through effective advocacy of policies to improve public health and ensure continued vitality of the life sciences sector. CHI’s website is Follow us on Twitter @calhealthcare, Facebook, LinkedIn and YouTube.

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Will Zasadny, Manager of Communications
California Healthcare Institute
since: 03/2010
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