11.11.15
Perhaps time really does heal old wounds. A half-dozen years ago, the medtech industry and U.S. Food and Drug Administration (FDA) were at odds over the agency’s product review process, considered back then to be unpredictable, inefficient and stifling to innovation. Premarket approval (PMA) review times averaged upwards of 400 days in 2008 and 2009, according to industry data.
Now, thanks to a newfound spirit of cooperation between the agency and industry (and some help from Congress), the FDA has cut those review times nearly in half. An infographic from the California Life Sciences Association (CLSA) shows that PMA review times have improved considerably and the 510(k) backlog has dropped significantly over the last several years. The infographic covers trending data about the FDA’s medical device review process over the last 15 years, specifically addressing PMA review times, 510(k) decision times, and variation in performance across the FDA’s Center for Devices and Radiological Health (CDRH) review divisions and branches.
The summary was developed in collaboration with the Boston Consulting Group.
“The FDA is a vital element in the medical technology innovation ecosystem, and has the challenging mission of balancing rigorous science and safety standards with the need for timely, predictable and efficient review processes,” said Sara Radcliffe, CLSA President and CEO. “We generated this report to illustrate the progress made by the FDA as well as to identify areas that could still benefit from further improvement. The decrease in review times over the last several years demonstrates the positive outcomes that can result from collaboration between industry, the FDA, Congress, and patients.”
Key facts and report highlights:
Born of a merger between BayBio and the California Healthcare Institute, CLSA boasts more than 750 members. The organization is tasked with advancing the Golden State’s life sciences innovation ecosystem by advocating for effective national, state and local public policies and supporting entrepreneurs and life sciences businesses.
Now, thanks to a newfound spirit of cooperation between the agency and industry (and some help from Congress), the FDA has cut those review times nearly in half. An infographic from the California Life Sciences Association (CLSA) shows that PMA review times have improved considerably and the 510(k) backlog has dropped significantly over the last several years. The infographic covers trending data about the FDA’s medical device review process over the last 15 years, specifically addressing PMA review times, 510(k) decision times, and variation in performance across the FDA’s Center for Devices and Radiological Health (CDRH) review divisions and branches.
The summary was developed in collaboration with the Boston Consulting Group.
“The FDA is a vital element in the medical technology innovation ecosystem, and has the challenging mission of balancing rigorous science and safety standards with the need for timely, predictable and efficient review processes,” said Sara Radcliffe, CLSA President and CEO. “We generated this report to illustrate the progress made by the FDA as well as to identify areas that could still benefit from further improvement. The decrease in review times over the last several years demonstrates the positive outcomes that can result from collaboration between industry, the FDA, Congress, and patients.”
Key facts and report highlights:
- With the exception of 2013, PMA average review times have declined steadily since 2010. In 2013 there was a surge in the proportion of devices sent to advisory committee panels for review, increasing from 8 percent in 2012 to 36 percent in 2013, and likely contributed to the slowdown in average review time that year. “Panel reviews are often used for innovative, first-in-class products, and the 2013 numbers may reflect a blip rather than a nascent trend,” the infographic states. “However, the panel-related data may reveal a topic worthy of further study by the agency and Congress given the implications, especially for small companies, which are particularly sensitive to lengthier review times and the costs or delays in revenue associated with them. Other data points to an improving environment for PMA product reviews, including an increase in the proportion of products receiving approval or approvable decisions and a reduction and stabilization in the agency’s decision backlog.”
- Fiscal year 2014 PMA average review times are on track to drop to their best performance since the year 2000.
- Recent decreases in 510(k) review times over the last three years suggest the first real improvement since 2005.
- The data show a trend in improved consistency across the system. Previously, review divisions and branches varied markedly in meeting their Medical Device User Fee Amendments PMA and 510(k) performance goals.
Born of a merger between BayBio and the California Healthcare Institute, CLSA boasts more than 750 members. The organization is tasked with advancing the Golden State’s life sciences innovation ecosystem by advocating for effective national, state and local public policies and supporting entrepreneurs and life sciences businesses.