From Toxic to Transparent: How Shuren's Leadership Transformed CDRHFrom Toxic to Transparent: How Shuren's Leadership Transformed CDRH

A look back at how far the Center for Devices and Radiological Health (CDRH) has come under the leadership of Jeff Shuren, MD.

Amanda Pedersen

July 25, 2024

4 Min Read
Headshot of CDRH Director Jeff Shuren
CDRH Director Jeff Shuren has announced his intention to leave FDA this year. Michelle Tarver, deputy director for transformation at CDRH, has been tapped as acting director of the group effective July 28. Image courtesy of FDA

The year 2009 is remembered in medtech regulatory circles as the year in which long-simmering turmoil erupted into the open at FDA's Center for Devices and Radiological Health (CDRH). It cost Daniel Schultz his job as CDRH director and prompted an external investigation of the 510(k) review program. But it also opened the door for change, and Jeff Shuren was up to the challenge.

This week Shuren told his staff he is stepping down after 28 years with FDA, the past 15 years of which have been spent at the helm of CDRH.

Michelle Tarver, deputy director for transformation at CDRH, has been tapped as acting director of the group effective July 28.

Shuren sought a more predictable CDRH

Shuren's goal when he took the job in late 2009 was to set clearer guidelines on "what situations might justify a change in our decision making and to determine how to communicate those changes to our external constituencies in a timely manner in order to achieve a reasonable level of transparency."

"We also recognize that in order to foster innovation, we need to provide industry with reasonably predictable pathways,” Shuren said at a public meeting in February 2010. “We will not accomplish this if we make our decisions to change course on an ad hoc basis or if we leave our external constituencies in the dark about our decision-making processes and our rationale.”

And so a new era was born, one in which the medical device industry and CDRH slowly began to see one another more as partners. "Jeff understood the critical role a regulator plays in the innovation ecosystem, knowing how to balance the ultimate goal of medical device safety and effectiveness with the important goal of spurring innovations that improve and safe lives," Scott Whitaker, president and CEO of AdvaMed, said in a statement after the news broke about Shuren's retirement.

Whitaker went on to praise Shuren's willingness to work with AdvaMed and the medtech industry to support next-generation innovation. He also made a pointed remark about working with Tarver to ensure that Shuren's "vision of a true public-private partnership remains the hallmark of the center."

Shuren led CDRH through a 'perfect storm'

While Shuren leaves behind a legacy of building a more transparent and collaborative CDRH, it's important to remember that the job wasn't easy, and that change didn't happen over night.

"We're in the midst of a perfect storm and I don't know where we'll come out," Shuren warned in April 2011. Here's a look at the key challenges the agency and industry faced at the time:

  • A global recession that caused medical device industry managers and venture capitalists to reduce or forgo investment in early-stage research.

  • Certain institutional review board policies that allegedly complicated U.S. clinical trials, encouraging sponsors to perform trials in Europe and elsewhere.

  • Continuing complaints from industry about the unpredictability of the CDRH review process (it was just a little over a year into the job, after all).

  • Globalization and an increasing CDRH workload with relatively high staff turnover and limited resources, including insufficient investment in regulatory science.

  • Applications for medical devices with greater complexity.

  • Established regulatory pathways that weren't always well-suited to evaluating rapidly evolving new technologies.

It was not long after citing that perfect storm that Shuren set out to fix what he agreed were flaws in the system. In June 2011, speaking at the Medical Device Manufacturers Association's annual meeting, Shuren acknowledged three major shortcomings that he would commit to addressing:

  • A lack of predictability and transparency in the medical device approval process.

  • Insufficient, changing, and “unreasonable” expectations for data and information to be provided to reviewers.

  • A high rate of staff turnover among CDRH reviewers and other personnel, which often delays the review process.

Under Shuren, CDRH ramped up its use of guidances to bring more transparency and predictability into the medical device review process. Up until that point, there was a dearth of written procedures that could clarify expectations and encourage consistency among reviewers.

“In the absence of guidance,” Shuren said, “expectations for material to be included in regulatory submissions were often simply passed down as ‘tribal law’ from reviewer to reviewer.”

A decade later, Shuren and CDRH were faced with the agency's greatest challenge of all: navigating the COVID-19 pandemic. It's hard to imagine how the CDRH that Shuren inherited in 2009 would have navigated such an immense challenge, but it's safe to say the cultural changes he implemented and the guidances that were published between then and 2020 went a long way toward preparing for the unexpected.

The following are just a few of Shuren's notable accomplishments at the helm of CDRH, according to FDA Commissioner Robert Califf's message to staff:

  • Increased the number of medical devices authorized annually in the United States five-fold.

  • Established the breakthrough devices program, which is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

  • Creation of the Digital Health Center of Excellence aimed at empowering stakeholders to advance healthcare by fostering responsible and high-quality digital health innovation.

  • Piloted the Total Product Life Cycle Advisory Program (TAP), enabling medical device companies to engage with the agency earlier for devices of public health importance. TAP was soft launched in January 2023 and expanded later that year.

About the Author

Amanda Pedersen

Amanda Pedersen is a veteran journalist and award-winning columnist with a passion for helping medical device professionals connect the dots between the medtech news of the day and the bigger picture. She has been covering the medtech industry since 2006.

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