For months, Minnesota's medical technology community has fretted over the Obama administration's new leadership team at the Food and Drug Administration, and whether the changes will result in a wholesale shift in the way medical devices are regulated by the federal agency.
Much curiosity has centered on the new head of the Center for Devices and Radiological Health, Dr. Jeffrey Shuren, whose office holds sway over products from the more than 200 medical device firms in the state.
In an interview Friday with the Star Tribune, Shuren provided few definite answers about the agency's plans. But he said issues such as a controversial approval pathway that generally doesn't require studies on patients are under review, and he also touched on hot-button topics such as the industry's influence on the FDA.
A neurologist who also holds a law degree, Shuren will visit the Twin Cities next week for an FDA town meeting on Tuesday at the Hilton Minneapolis-St. Paul in Bloomington. He said the meeting will touch on "all issues, concerns, topics [that] are on the public's mind" regarding the FDA.
He'll also give an update on his own initiatives at the agency. Two additional public meetings -- in Boston and in Los Angeles -- are scheduled for later this year.
Shuren said the Institute of Medicine, an independent entity that provides advice to policymakers, is looking at the "510(k)" approval process, under which companies need only prove their products are "substantially equivalent" to ones already on the market to gain approval. Often this does not involve expensive clinical studies on patients to prove a device is safe and effective, but that may be changing.
Shuren said a final report from the institute is due in the summer of 2011. In the meantime, he said, the FDA is also performing its own assessment and will likely issue some guidelines in coming weeks.
"If there are particular [changes] that are no-brainers, and people uniformly say, 'This is worth doing,' we can start working on them now," he said. "Then, any of the recommendations that we don't adopt, if we think they require greater vetting, or if there's a lot of difference of opinion, we'd leave them out there for the Institute of Medicine process to consider."
No stranger to the FDA, Shuren held various policy and planning positions within the agency from 1998 to 2009, and was named to head the device division by FDA Commissioner Dr. Margaret Hamburg in January.
He said the 510(k) study was requested "in light of questions and concerns that were raised -- by industry, patient groups, the health care community and our own staff. We felt the best way to address concerns is to undertake a more comprehensive assessment of the process and do it in a very public way."
Under previous leadership, the FDA came under fire from consumer groups for what some saw as a too-cozy relationship with industry. But device companies said the agency was so disorganized that it was difficult to gain clarity regarding product approvals, uncertainty that made it difficult for small start-up companies to raise money.
Shuren touched on a number of other topics during the 30-minute interview:
On the charge that changing the 510(k) approval process will hamper innovation of new medical devices: "We're looking at the impact it has had on innovation, and if there has been an adverse impact, what we can do to provide greater predictability in the program."
On other initiatives at the FDA: "We're working on stronger guidance for industry about how they design clinical trials to support their pre-market applications. We've heard there's a lack of clarity. We're also taking steps to improve our oversight of imported products."
On post-market surveillance of medical devices once they're implanted in patients: "One is greater investment in the development of medical device registries. We're also developing a unique device identifier." (Once a device is implanted in a patient, his or her medical records will reflect the make, model and other information, making it easier to track.)
On charges that some advisory panel members considering approval of medical devices have industry ties, and therefore pose a conflict of interest: "We have tried to get people with the right experience on our panels. We keep a large pool of experts whom we can pick and choose from depending upon the topic that comes up. But when there are conflicts of interest, it can limit our ability to use those individuals. We've centralized our advisory committee process, we have a much more standardized approach in how we put these panels together to get the right expertise."
On why he took the job: "I believe very strongly in the benefits that medical devices can have in health care. ... [I] saw it as a wonderful opportunity to have what I hope will be an impact on public health and health care generally."
Members of the public interested in attending Tuesday's 8 a.m.-to-noon meeting will be admitted on a first-come, first-served basis. The Hilton is at 3800 E. American Blvd., Bloomington.
Janet Moore • 612-673-7752