New Report Finds Improvement in FDA Medical Device Review Times


California Life Sciences Association (CLSA) and Boston Consulting Group (BCG) Report Shows Progress Made, but Room for Improvement Remains

 SOUTH SAN FRANCISCO – OCTOBER 15, 2015 – The California Life Sciences Association (CLSA), the leading voice to drive innovation for California’s life sciences sector, today released an infographic report that covers trending data about the U.S. Food and Drug Administration’s (FDA) medical device review process over the last fifteen years. With cooperation from the FDA, CLSA investigated several issues that impact average times for medical device product reviews.

The summary, titled Recent Trends in FDA Medical Device Regulation includes premarket approval (PMA) review times, 510(k) decision times, and variation in performance across the FDA’s Center for Device and Radiological Health (CDRH) review divisions and branches. CLSA developed the report 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.
  • 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 shows a trend in improved consistency across the system. Previously, review divisions and branches varied markedly in meeting their MDUFA PMA and 510(k) performance goals.

These trends are getting the attention of industry leaders. “The recent and real improvements in FDA’s medical device review times sends a positive signal to companies and investors developing new lifesaving devices for patients in need,” said Don Bobo, Corporate Vice President of Heart Valve Therapy, Corporate Strategy and Corporate Development, Edwards Lifesciences. “We look forward to continuing the productive partnership with the agency in the years to come in order to ensure patients have access to important new therapies in a timely fashion.”

“Our report reflects the strong efforts made by FDA leadership and between the FDA, Congress and industry to decrease medical device review times and improve consistency throughout the Agency,” said Todd Gillenwater, CLSA’s Executive Vice President of Advocacy and External Relations. “However, there is still more that can be done. CLSA looks forward to continuing collaboration with the FDA and Congress to meet our shared goals.” 

Click here to view the full report on CLSA’s website.
Click here to view a PDF version of the report.
Click here to view press release on PRWeb.

About California Life Sciences Association (CLSA)
California Life Sciences Association (CLSA) is the leading voice for California’s life sciences sector. We work closely with industry, government, academia and other stakeholders to shape public policy, drive business solutions and grow California’s life sciences innovation ecosystem. CLSA serves more than 750 biotechnology, pharmaceutical, medical device, and diagnostics companies, research universities and institutes, investors and service providers. CLSA was founded in 2015 when the Bay Area Bioscience Association (BayBio) and the California Healthcare Institute (CHI) merged to create the state’s most influential life sciences advocacy and business leadership organization. Visit CLSA at, and follow us on Twitter @CALifeSciences, Facebook, Instagram, LinkedIn and YouTube.

About Boston Consulting Group
The Boston Consulting Group (BCG) is a global management consulting firm and the world’s leading advisor on business strategy. We partner with clients from the private, public, and not-for-profit sectors in all regions to identify their highest-value opportunities, address their most critical challenges, and transform their enterprises. Our customized approach combines deep insight into the dynamics of companies and markets with close collaboration at all levels of the client organization. This ensures that our clients achieve sustainable competitive advantage, build more capable organizations, and secure lasting results. Founded in 1963, BCG is a private company with 82 offices in 46 countries. For more information, please visit

Will Zasadny
Manager, Communications for CLSA