FDA, MN medtech execs meet in Mpls.by Martin Moylan, Minnesota Public Radio
MINNEAPOLIS — U.S. Food and Drug Administration Commissioner Margaret Hamburg met with some medical device industry executives Wednesday in Minneapolis to discuss the agency's review process.
Medical device companies have long complained the FDA takes too long to review and approve new products. But both sides at the meeting agreed the FDA review and approval process has been improving but needs to get better.
"The issues of delay and funding, etc. ... those are still there," said Dale Wahlstrom, president and CEO of industry group LifeScience Alley. "What I'll say is that the trajectory feels like it's beginning to change and it is beginning to move in the right direction."
Hamburg said her agency is committed to addressing industry concerns while staying focused on safety.
"This is an ongoing activity, where we have a lot to accomplish and a lot of benchmarks by which we'll be measured," Hamburg said. "But we are very committed to this. And it is a true partnership, where industry also has to step up to the plate in a some critical areas."
Earlier this year, Congress passed legislation to increase FDA staffing and speed up product reviews. The agency says it has reduced the backlog of devices awaiting study and decisions are coming faster.
The medical device industry employs about 35,000 Minnesotans.