ARTICLE SUMMARY:
Strategies for coping with rapidly changing FDA requirements from agency veteran Kwame Ulmer. By Kwame Ulmer, Principal, Ulmer Ventures
Changes, both large and small, are stirring at US FDA. A new commissioner (acting for now) is in place, 510(k) reforms are afoot, and, lest we forget, the recent government shutdown left an entire nation wondering if their critical medical device facilities were being inspected. Moreover, technology is rapidly accelerating, and FDA is grappling with how to adjust its frameworks to new digital realities.
These changes pose key challenges and raise significant questions for the medtech industry leader: How do I gauge the significance of any particular change? What is the proportionate response to that change? What is the best timing for actions?
