Former CDRH director Dan Schultz had this to say when reflecting on his tenure at the center’s helm:
“When I look back over the last five years, I see many CDRH accomplishments to reflect on and many unfinished tasks still ahead. The implementation of device user fees with its influx of resources and people has led to a more efficient and consistent premarket review process. Scorecards, project management plans, and extensive IT innovations have allowed us to track, measure, and adjust our programs while adding increased accountability. Science prioritization has both strengthened our research enterprise and ensured that science and regulation are firmly integrated in all of our many activities. And the postmarket transformation process has provided an opportunity to fundamentally rethink the way that risk/benefit information is collected, analyzed, and acted upon using all available resources within the center and utilizing available data and opportunities for collaboration outside the center as well. The matrix as both a construct and a concept is identifying and implementing new paths to a more effective CDRH and better risk management for the products we regulate.
“There is always more to be done. Developing methodologies for quantitative decision making across the product life cycle will not only allow us to make better decisions but will enhance our ability to explain and replicate those decisions. Working within the center and with other agency colleagues to prioritize and streamline the processes for regulation, policy, and guidance development will provide greater clarity both internally and externally as to the responsibilities that each of us has in maximizing the safety and effectiveness of the products that we regulate. Linking internal performance goals to public health outcomes and budget allocations in a way that can be measured and communicated will enhance the center’s fiscal strength and our ability to advance public health through access to better and safer medical devices and radiological products.â€
—Jim Dickinson (Washington Wrap-Up, MD&DI October)
[Read more about Schultz's resignation in Jim Dickinson's Washington Wrap-Up column in the October issue of MD&DI]
The Associated Press has reported that Daniel Schultz, head of CDRH, is resigning his post. In a letter to agency staffers, Schultz said that he and FDA Commissioner Margaret Hamburg agreed that his resignation “would be in the best interest of the center and the agency,†according to the Associated Press.
Earlier this year, nine scientists wrote a letter to Obama’s transition team that alleged that the device approval process was corrupted. The letter, coupled with growing complaints about the 510(k) process, have led to increased scrutiny of CDRH methods. This month’s Washington Wrap-Up column takes a closer look at Schultz’s role in the process.
AdvaMed released the following statement after Schultz’s departure:
“Dan Schultz served the nation for more than 30 years promoting and protecting the public health as a member of the U.S. Public Health Service. Dan supervised FDA’s device center at time of unprecedented scientific advancement and helped continue U.S. leadership in the development of safe and effective medical treatments. As CDRH director, Dan was instrumental in crafting the historic agreement in 2007 reauthorizing medical device user fees, which has provided FDA’s device program with a stable source of funding to help meet its regulatory responsibilities. In addition, he launched CDRH’s Postmarket Transformation Initiative, which is designed to improve the collection, analysis and utility of the agency’s multiple sources of postmarket medical device data. Dan also has been a leader in efforts to strengthen and harmonize global medical device regulatory requirements and has supported FDA’s work on the Global Harmonization Task Force. We wish Dan all the best in his future endeavors and look forward to working with Acting CDRH Director Jeff Shuren as the search for a permanent director of the device center proceeds.â€
[from DeviceTalk]
FDA has concluded that dental amalgam fillings are not a health hazard. The agency reached this conclusion after a six-year review of hundreds of studies on the fillings. What makes FDA’s position a little puzzling is the fact that just last year, CDRH issued a new policy statement that recognized health problems posed by mercury amalgam. The risks were notably higher for children (fetuses included), pregnant women, and others with mercury immuno-sensitivity or high mercury body burdens. The page containing CDRH’s previous statement statement has been taken down.
Susan Runner, who leads CDRH’s Dental Devices Branch, had this to say: “The best available scientific evidence supports the conclusion that patients with dental amalgam fillings are not at risk for mercury-associated adverse health effects.”
