Hello Rapid Response Subscriber,

This is week 2 of rapid response updates! You will also see last week’s updates included. 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 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 Rumors Clarified

What’s Happening:

Recent speculation about a potential FDA center reorganization—consolidating drugs, biologics, devices, tobacco, and foods under a new “Office of Product Evaluation and Regulation”—has been officially addressed. In an interview with Inside Medicine, FDA Commissioner Makary confirmed there will be no major reorganization of FDA centers. While some administrative functions such as travel and IT are being consolidated for efficiency, the commissioner emphasized the agency will continue working within its existing structure.

Why It Matters:

The clarification removes uncertainty around a possible structural overhaul that could have impacted regulatory review processes, user fee programs, and industry engagement. With center structures remaining intact, ongoing stakeholder relationships and engagement, channels are expected to remain stable.

What’s Next & AdvaMed Action:

AdvaMed will continue to monitor FDA leadership communications and evaluate any operational changes affecting MedTech regulatory pathways. No further action is required from members currently, but we welcome any feedback or questions.

Issue 2: Executive Orders on Federal Procurement Reform

What’s Happening:

President Trump issued two Executive Orders aimed at overhauling federal procurement processes:

Restoring Common Sense to Federal Procurement: This order mandates a comprehensive reform of the Federal Acquisition Regulation (FAR) to eliminate unnecessary regulations and streamline procurement procedures.
Ensuring Commercial, Cost-Effective Solutions in Federal Contracts: This order emphasizes the procurement of commercially available products and services to the maximum extent practicable, aiming to reduce costs and integrate private sector innovations into federal contracts.

Why It Matters:

These reforms could impact industry engagement with federal procurement, potentially reducing barriers and opening opportunities for commercial products in government contracts.

What’s Next & AdvaMed Action:

AdvaMed is analyzing the implications of these orders on the MedTech industry. We welcome member feedback on how these changes may affect your operations and procurement strategies. Please share your insights via email rapidresponse@advamed.org.

Issue 3: Supreme Court Review of Kennedy v. Braidwood Management, Inc.

What’s Happening:

On April 21, 2025, the U.S. Supreme Court heard oral arguments in Kennedy v. Braidwood Management, Inc., a case challenging the authority of the U.S. Preventive Services Task Force (USPSTF) under the Affordable Care Act (ACA). The plaintiffs argue that the USPSTF's recommendations, which mandate insurance coverage for preventive services, are unconstitutional due to the Task Force's appointment process. Following the arguments, the Court ordered additional briefing to address whether the Secretary of Health and Human Services has the power to appoint USPSTF members, a central issue in the case.

Why It Matters:

The outcome is likely to affect coverage requirements for various medical services and devices, potentially leading to uncertainty in healthcare coverage and reimbursement structures. .

What’s Next & AdvaMed Action:

The Supreme Court may remand the case for further analysis, delaying a final decision. AdvaMed is closely monitoring the proceedings and will assess any impacts on the MedTech industry and will keep members informed.

Issue 4: OMB Request for Information on Deregulation

What’s Happening:

The Office of Management and Budget (OMB) has issued a Request for Information seeking public input on federal regulations that may be outdated, unnecessary, or overly burdensome. The initiative aims to identify opportunities for deregulation across various sectors.

Why It Matters:

This RFI presents an opportunity for the MedTech industry to provide input.

What’s Next & AdvaMed Action:

AdvaMed requested member feedback from across our policy teams and divisions and is preparing comments in response to the RFI focused on deregulation for the benefit of innovation and patient care. Public comments are due May 12, 2025.

Issue 5: Nairobi Protocol Webinar Recording Available

What’s Happening:

This 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 new tariffs on global markets.

What’s Next & AdvaMed Action:

The recording is now available on demand here.

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.