FDA's Shuren testifies in favor of reauthorizing device user fee

Responding to industry-wide criticism of the clearance process for medical devices, Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health (CDRH), said a root cause of the perceived lack of predictability, consistency and transparency is funding.

In a Nov. 15 testimony before the Senate Committee on Health, Education, Labor and Pensions, Shuren outlined efforts within the center to improve the medical device clearance process. He then called for a “seamless” reauthorization of the Medical Device User Fee Act (MDUFA).

The U.S.-based medical device market is currently the fourth largest sector for venture capital, Shuren pointed out, and more than 62 percent of the $631.4 million invested in life science ventures in the third quarter of 2011 went to medical device companies. Despite the poor economy, the industry has also produced a net gain in jobs since 2005, said Shuren.

Shuren noted that low-risk 510(k) devices without clinical data—which represent 80 percent of all devices reviewed annually—came to market in the U.S. as often as, or more often than, in the European Union (EU). The EU typically clears higher-risk devices faster than the U.S. However, their requirements are based on safety and performance, as opposed to the Unites States' safety and effectiveness-based requirements.

The FDA completes at least 90 percent of 510(k) reviews within 90 days or less, according to Shuren. However, average total days for the review of 510(k) devices have been increasing since 2005, as have premarket approval applications.

“FDA recognizes that, if the United States is to maintain its leadership role in this area, we must continue to streamline and modernize our processes and procedures to make device approval not just scientifically rigorous, but clear, consistent and predictable without compromising safety,” said Shuren.

Among some of the input the FDA solicited from stakeholders, Shuren noted the following:

• Industry found that inadequate predictability, consistency and transparency were stifling innovation and driving jobs overseas.

• Third-party payors and healthcare professionals found the 510(k) program did not provide adequate protection for patients and didn’t generate sufficient information for practitioners and patients.
• CDRH employees were also concerned the 510(k) program hadn’t adapted to the increasing complexity of devices.

The administration also sought comments on the 510(k) process from the Institute of Medicine, which recommended scrapping the program altogether.

Among numerous problems identified within the FDA and CDRH—such as insufficiently trained staff and high turnover of employees—Shuren said a key problem is funding.

“While it is true that providing more user fee resources alone won’t solve the problems with our premarket programs, insufficient funding is at the root of, or a contributing factor to several of these problems,” said Shuren. “Adequate and stable funding is one key component to our and industry’s success in bringing safe and effective devices to market quickly and efficiently.”

In conclusion, Shuren stated that an ongoing culture change within the CDRH will improve transparency, predictability and efficiency. The current enactment of MDUFA is scheduled to expire on Sept. 30, 2012, and Shuren said its reauthorization is necessary.

“If we are to sustain and build on our record of accomplishment,” he said, “it is critical that the MDUFA reauthorization occurs seamlessly, without any gap between the expiration of the old law and the [third] enactment of MDUFA.”