FDA 510(k) reaction: The trade group (Minnesota)
Cautiously optimistic was the word from one trade group after the FDA released details Wednesday on current and future plans for changes to the 510(k) medical device approval process. "They're moving in a positive direction," Dale Wahlstrom, CEO of LifeScience Alley, the Minneapolis-based nonprofit trade association, said in a phone interview. "I was surprised to see 25 things they're doing right now to make it better, with really tight timelines. That to me says they want to show success quickly, and that's good as long as they implement with an appropriate amount of detail that doesn't catch us by surprise." The detail, of course, is the catch. "The area of concern is the significant number of items that they delayed decision on as they move into dialog with IOM."
