WASHINGTON, D.C. -- Center for Devices and Radiological Health Director Jeffrey Shuren aimed to reassure attendees of the 16th Medical Device Manufacturers Association meeting Tuesday that the center is fresh, more open place. Shuren made brief opening remarks before going into a Q&A session, deciding not to launch into a discussion of the center's priorities. And just like talk show hosts of old--Phil Donahue was invoked--he brought the microphone to audience members to elicit their questions and concerns.
Shuren's presentation seemed to show off the new, transparent, almost hip CDRH. The center now has a Twitter account. And, in an effort to increase transparency, it recently launched a website to provide information about medical device and radiation-emitting product regulatory processes and decisions. The center also recently embarked on a series of town hall meetings (though media reports have said the recent one in Minnesota was rather contentious).
When asked about the 510(K) process, Shuren said he doesn't know where precisely it is going, but it certainly won't be scrapped. He believes the system works well, although he knows there are those in the industry with "angst" about the program--and he has seen this concern increasing. But the largest challenges pertain only to a small minority.
The center is undertaking a two-prong assessment, with the IOM conducting research for what he called a "deep dive" report that is due out in the summer of 2011. He acknowledged that this a long wait, and as an agency, the FDA has the obligation to look at its own programs, so it's doing its own assessment. Shuren said that a preliminary report is due this summer, and if the center sees a groundswell of support for certain ideas, it will act quickly to implement them. Ideas that are more controversial will be left to the IOM.
This process hasn't been without its detractors. In a recent interview with the Minneapolis Star-Tribune, Shuren was asked to comment about certain complaints that changes to the process could hamper innovation. He responded that the center is taking the assessment precisely because industry has complained that the current system hampers innovation.
In addition, Shuren said that he'd like to see a bit of a culture change at the CDRH, allowing it to take a greater role in promoting public health--including facilitating innovation. For example, he'd like to make the center's expertise more available. Why is the FDA sitting back and allowing industry to solve all the problems when it could add its knowledge--it has devicemakers' proprietary and postmarket data, so it can help resolve problems.
Shuren also discussed the new Council on Medical Device Innovation, which brings together the FDA, NIH, CDC, CMS, Defense Department and Department of Veterans Affairs. Experts from these agencies will determine where the greatest needs are: That is, what devices can be developed to best improve public health, and what are the barriers prevent these devices from being developed. Shuren said a public meeting will be held in a few weeks to start the dialogue.
FDA Principal Deputy Commissioner Joshua Sharfstein also spoke via phone and emphasized the agency's commitment to cultivating an effective relationship with the industry.
During his talk, Sharfstein said the agency is trying to assuage fears that the FDA will be too conservative and overemphasize risks over benefits when evaluating medical devices. Former Minnesota Governor Arne Carlson raised this very concern in a recent op-ed: "The FDA must reinstate a culture of balancing patient risk and benefit to find ways to accelerate the innovation process and to halt this trend of slowing down or delaying device reviews. The agency must honor its existing agreements with device companies and change the rules only if new science obsoletes an ongoing trial or if there is a proven new safety risk." Sharfstein tried to allay the fears of devicemakers by saying the agency would safely balance risks and benefits when assessing medical devices.
He also discussed FDA-TRACK, a new agency-wide program performance management system that monitors more than 100 FDA program offices through key performance measures. Each quarter, monthly performance data is analyzed and senior managers present this data to FDA senior leadership. CDRH has six FDA-TRACK program areas for its eight offices, and one of the metrics it covers is resolution rates of 510(K)s. Members of the public can look at the data and comment on whether they think another measure would be better. - Liz Jones (twitter | email)