In a provocative feature published on July 8, 2025, The New York Times Magazine explored the dramatic restructuring of the U.S. Food and Drug Administration under HHS Secretary Robert F. Kennedy Jr., calling it nothing short of an institutional collapse (“The Collapse of the FDA,” NYT Magazine). The article highlights sweeping staff reductions, dismantling of review systems, and a pivot in regulatory priorities — all of which could significantly alter the path to U.S. market access for medical device manufacturers.
For companies operating in this space, especially foreign manufacturers seeking FDA clearance or relying on a stable regulatory environment, this shift introduces new uncertainty. Reduced enforcement capacity, altered timelines for reviews, and a shrinking pool of experienced FDA reviewers may create bottlenecks — or open the door to increased scrutiny on post-market surveillance and quality systems.
At RQMIS, we believe this is a time not for panic, but for preparedness. As regulatory norms are tested and redefined, having an expert Initial Importer and regulatory partner is more important than ever. We help clients anticipate changes, interpret evolving guidance, and maintain compliance across fluctuating policy landscapes.
In times of regulatory transition, clarity is power. RQMIS remains committed to delivering that clarity, so your innovation stays on track — and your business stays compliant.
For a conversation about how these developments may impact your market strategy, reach out to RQMIS today.