Hello Rapid Response Subscriber,

This is week 5 of rapid response updates! As part of our effort to keep you in the loop, you’ll be getting an email update from us each week covering both emerging policy issues impacting industry and responsive AdvaMed activity.

Visit the Emerging Policy Response Center
Stay current on the latest updates, advocacy efforts, and resources to help navigate evolving policies. Encourage your colleagues to sign up for these weekly updates to stay informed and engaged!

If there are any issues, you'd like more information on—or emerging topics you'd like us to explore—please don’t hesitate to reach out.

Issue 1: Trade Policy Collaboration

What’s Happening:

AdvaMed and Swiss Medtech have jointly called on the U.S. and Swiss governments to pursue a “zero-for-zero” reciprocal tariff agreement for medical technologies and to formally recognize FDA approvals and clearances as part of regulatory alignment. These recommendations were outlined in a joint statement released ahead of the May 2025 U.S.–Switzerland Trade and Investment Dialogue.

Why It Matters:

Eliminating tariffs and reducing duplicative regulatory requirements would lower costs, streamline market access, and strengthen transatlantic MedTech supply chains. Recognition of FDA approvals could also enhance global competitiveness for US manufacturers. .

What’s Next & AdvaMed Action:

AdvaMed will continue advocating for these trade and regulatory priorities.

Issue 2: MAHA Commission Report on Childhood Chronic Disease

What’s Happening:

The Medical and Health Accountability (MAHA) Commission released a 68-page report today addressing the rise of chronic disease in children. The report outlines three main drivers the Commission will focus on in an upcoming August strategy release: overprocessed foods, environmental chemicals, and overmedication of children.

Why It Matters:

The report criticizes the food, chemical, and pharmaceutical industries for contributing to poor pediatric health outcomes. It raises concerns about rising prediabetes rates and post-market surveillance—especially for pediatric drugs—and hints at the role AI could play in monitoring health trends.

What’s Next & AdvaMed Action:

AdvaMed is continuing to review the report closely for implications to medtech. A second report with policy recommendations is expected.

In Case You Missed It (Week 4 Recap)

1. Supreme Court Review: Kennedy v. Braidwood Management, Inc.

Issue:The challenge to the authority of the U.S. Preventive Services Task Force under the ACA.
Why It Matters: Potential implications for coverage of preventive services and structural authority under the ACA.
AdvaMed Action: Released an executive overview developed with legal counsel; a member webinar will follow once a decision is issued

2. Executive Orders on Federal Procurement Reform

Issue: Two EOs aim to streamline federal procurement and promote use of commercial products.
Why It Matters: May reduce barriers for MedTech companies and improve government contracting efficiency.
AdvaMed Action: Met with the Coalition for Common Sense Government Procurement and continues monitoring implementation guidance.

Other RFIs/Comments We Are Tracking

To ensure alignment and efficiency, AdvaMed will continue to coordinate responses across teams and ensure consistency across related RFIs.

The Office of Management and Budget (OMB) has issued a Request for Information seeking public input on outdated, unnecessary, or burdensome federal regulations as part of a broader deregulatory initiative. This effort provides a platform for the MedTech industry to identify regulatory barriers that hinder innovation or patient care. AdvaMed has solicited member input across policy teams and divisions and has officially submitted comments. Access the submission here.
The U.S. Department of Health and Human Services (HHS), in coordination with the FDA, has issued a Request for Information (RFI) seeking public input on regulations that should be modified or eliminated across all HHS agencies. The initiative supports the administration’s 10-to-1 deregulatory policy and broader efforts to reduce regulatory burdens on providers and the healthcare system. The public comment portal is now open, and responses will be accepted for 60 days.
The Department of Justice (DOJ) has launched an Anticompetitive Regulations Task Force and issued a Request for Information (Docket No. ATR-2025-0001), seeking public input on laws and regulations that may hinder competition. In addition, the DOJ and Federal Trade Commission (FTC) issued a joint letter directing federal agencies to identify regulations that reduce competition, entrepreneurship, and innovation. Comments are due by May 26.
The Centers for Medicare & Medicaid Services (CMS) has issued a Request for Information on Medicare Regulatory Relief, inviting input on policies that may create unnecessary burdens or limit access to care. The comment deadline is June 10.