Thank you for signing up for rapid response updates! As part of our effort to keep you in the loop, you’ll be getting a quick update from us each week – either by email or through a brief call – covering both emerging policy issues impacting industry and responsive AdvaMed activity. We plan to have all updates use a format like what you see below.
We welcome your insights and questions on any of the topics included. Please don’t hesitate to reply directly or raise additional concerns through the submission portal on our Emerging Policy Response Center. We also encourage your feedback on this update’s format, level of detail, or anything else that can help us relay the information better.
Issue 1: FDA Reorganization and User Fee Implications
What’s Happening:
HHS has proposed an FDA reorganization that would consolidate all product review centers—drugs, biologics, devices, tobacco, and foods—into a new “Office of Product Evaluation and Regulation.” It would also centralize compliance, policy, and administrative functions.
Why It Matters:
This effort to streamline and align regulatory functions may influence future user fee structures and engagement strategies.
What’s Next & AdvaMed Action:
We are monitoring how these changes may impact the medtech industry, particularly around user fee negotiations and implementation timelines.
Issue 2: Richardson Waiver Repeal Webinar Recording Available
What’s Happening:
A recent webinar reviewed the repeal of the “Richardson Waiver,” a memo that had established voluntary procedural steps for HHS rulemaking.
Why It Matters:
The repeal could accelerate rulemaking timelines and reduce procedural transparency, affecting how stakeholders respond to new regulations. Implications for compliance under the Administrative Procedure Act (APA) and downstream effects on MedTech innovation were discussed.
This upcoming webinar will explore the Nairobi Protocol and its relevance to medical device manufacturers.
Why It Matters:
Understanding this international trade agreement can help medtech companies navigate tariffs, customs procedures, and better consider their approach to global markets.
What’s Next & AdvaMed Action:
Topics include eligibility standards, required documentation, and operationalization in non-U.S. markets. Members are encouraged to register here.
Issue 4: Port Fees on Chinese Vessels
What’s Happening:
USTR released its final actions on the Section 301 China shipbuilding investigation. In a positive step, USTR made significant changes from the initial proposed actions. They have removed the fees for vessel operators with Chinese-built ships on order or those who have Chinese-built ships in their fleet. They have changed the fee to apply per U.S. voyage and no more than five times a year. The fees have been changed from a flat fee to a fee based on the net tonnage of the vessel. The fees will also be phased in.
Why It Matters:
Chinese-owned vessels account for roughly 60% of global shipping capacity. Additional fees could raise costs for medtech companies that rely on international logistics. Members that rely heavily on cargo shipping to move product have expressed concerns about additional fees.
What’s Next & AdvaMed Action:
AdvaMed is monitoring this development to better understand the impact on members. We will continue to advocate for policies that ensure supply chain stability and affordability for our members.
Help Shape Our Rapid Response Priorities
As the new administration accelerates policy changes across the health and trade landscape, we want to ensure we're addressing the most urgent issues facing the industry. Submit topics or concerns for rapid response consideration here.
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