This post is sponsored by LifeScience Alley.
On Tuesday, May 18, over 400 medical device manufacturers, patients, health care consumers, regulatory and clinical consultants, venture capitalists, and other professionals from Minnesota’s life science community filled a large ballroom at the Hilton’s Airport location to hear and speak with senior leaders from FDA’s Center for Devices and Radiological Health (CDRH).
As FDA is in the process of internally reviewing various aspects of medical device clearance programs, namely the 510(k) clearance process, CDRH’s director Dr. Jeffrey Shuren and key members of his senior staff are making stops in Minneapolis, Boston, and Los Angeles to meet with the local medical technology communities. The FDA Town Hall programs are serving as a platform to deliver CDRH’s 2010 Priorities, and as a forum to solicit input and concerns from people from industry, academia, government, and the general public.
When Investment Rhymes with Canada
Canada has a proud history of achievement in the areas of science and technology, and the field of biomanufacturing and life sciences is no exception.
During the Town Hall Meeting, thirteen pre-registered speakers offered their concerns and thoughts on the current medical device clearance processes. Common themes of concern included a lack of predictability in the processes, a lack of timely communication from FDA regarding changes, and varying interpretations of FDA’s role in the process by individual reviewers.
More importantly, at a time when medical device companies are facing challenges like the $20 billion excise tax (part of national health care reform), there is industry-wide concern that FDA will increase the regulatory burdens necessary to bring new technology to market, thus increasing time to bring life-enhancing products to patients, and increasing costs. There is already a dearth of early-stage start-up funding available in many parts of the country, and an increasingly burdensome and unpredictable regulatory process only hurts the ability of promising companies to attract what little start-up money exists.
LifeScience Alley’s Activities
LifeScience Alley formed a 510(k) Action Committee, comprised of prominent members of the local medtech regulatory community, to provide insightful feedback and reasoned input to FDA and federal lawmakers during the process of review. The committee has met regularly for the past several months and has been building a case to protect a clearance process that ensures patient safety and promotes innovation in medical technology.
Following the FDA Town Hall Meeting on May 18, several members of the Action Committee held a private audience with Dr. Shuren to discuss key positions on potential changes to the 510(k) process. LifeScience Alley and the Action Committee have been following progress at the federal level and will be issuing an interpretation of FDA’s initial findings from its internal review of the 510(k) process, due for public comment before the end of June.
Please visit www.LifeScienceAlley.org/advocacy for more information on LifeScience Alley’s advocacy efforts on behalf of the life science industry.
