'Not Going Back' to the Shultz Era of Medical Device Regulation

As Jeffrey Shuren, MD, approaches his retirement after 15 years leading FDA's Center for Devices and Radiological Health (CDRH), a controversial New York Times investigation casts a shadow over his legacy.

This report raises serious questions about potential conflicts of interest during his tenure, yet it fails to recognize the critical advancements in medical device regulation achieved under his leadership.

The report focuses on a potential conflict of interest: during Shuren’s tenure, his wife, Allison, co-led a team of lawyers representing medical device manufacturers at Arnold & Porter, a leading Washington law firm.

The New York Times reviewed thousands of court documents, FDA records, and conducted interviews, finding several instances where the Shurens' roles intersected.

The report highlights that while Shuren signed ethics agreements to avoid conflicts with Arnold & Porter’s business, it is unclear how strictly these were enforced. An FDA spokesperson acknowledged some instances a decade ago where Shuren should have recused himself or sought ethics authorization to prevent any appearance of bias. However, there is no evidence that he acted improperly or violated any laws.

Nevertheless, the perception of bias can undermine public trust in FDA whether any laws were broken or not. The agency’s role is not just to enforce rules but to maintain public confidence in its impartiality, especially when senior officials have potential conflicts of interest. This is why ethical guidelines are so critical—they safeguard not only against actual wrongdoing but also against any doubt that might arise about the integrity of regulatory decisions.

The problem with the New York Times report is that it misses the forest for the trees. Those who have been around the medical device industry long enough to remember what the regulatory climate was like under Shuren’s predecessor, Daniel Shultz, and the hot mess that was the CDRH when Shuren took the post, can appreciate how much progress has been made in the last 15 years, both for industry and for patient safety.

During Shultz’ reign, a group of FDA scientists and physicians known as The FDA Nine sent a whistleblower letter to Congress and the Obama administration. They alleged that CDRH managers had coerced FDA experts into altering their scientific reviews and recommendations unlawfully.

This letter, along with a follow up letter in January 2009, brought congressional scrutiny that had a significant impact on FDA’s 510(k) review process and brought what the device industry largely perceived as negative changes.

In May 2009, new public disclosures revealed that Schultz had overruled staff objections to approve ReGen Biologics' Menaflex collagen scaffold via the 510(k)-clearance process. An internal investigation later found this posed a “definite threat” to the integrity of the device’s review.

There is plenty of room for further progress, but overall, the state of medical innovation and patient safety is far better today than it was before Shuren took the helm.

When Shuren took the CDRH director post, his goal 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."

"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 than adversaries.

Shuren increased the use of guidance documents at CDRH, improving transparency and predictability in the medical device review process. Before this, there were few written procedures to clarify expectations and ensure 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.”

Other examples of progress under Shuren’s tenure include the breakthrough devices program, which improves Americans’ access to new innovation for life-threatening or irreversibly debilitating diseases or conditions; the Digital Health Center of Excellence; and the Total Product Life Cycle Advisory Program (TAP), which enables medical device companies to engage with the agency earlier for devices of public health importance.

While The Times noted an increase in medical device safety issues under Shuren, this is due to improved transparency and stricter reporting requirements. Most manufacturers are more diligent in reporting, creating an impression of more issues, when in fact, the public is just better informed.

The New York Times did make some good points. I mean let’s face it, Shuren did seem a little too cozy with industry at times. But that shouldn’t negate all the progress made in the past 15 years that has benefited medical device manufacturers and consumers.

I hope future leadership will build on Shuren’s legacy of transparency and predictability rather than go backward. His successor must understand how to use medical device regulation to protect patients from shoddy devices while also bringing lifesaving and life improving innovation to the U.S. market.

And to steal a phrase from a certain political party, medtech is “not going back” to the Shultz era of medical device regulation.