Orthogonal, Kwame Ulmer on the Value of AdvaMed Membership
At AdvaMed, we’re proud to be recognized for our work on behalf of the medtech community – and we’re especially grateful when that recognition comes from respected voices like Kwame…
Regulatory Affairs
Learn more about our Regulatory Affairs work.
AdvaMed Releases “AI Policy Roadmap” to Guide Congress and Federal Agencies
Washington, D.C.—AdvaMed, the Medtech Association, today released its “AI Policy Roadmap,” a detailed policy outline for Congress and the federal agencies with jurisdiction over medtech to consider in promoting the…
AdvaMed Congratulates Dr. Oz on his Confirmation as CMS Administrator
Washington, D.C.– AdvaMed®, the Medtech Association, today released the following statement from President and CEO Scott Whitaker on the U.S. Senate’s confirmation of Dr. Mehmet Oz to serve as Administrator of…
Medical Device Submissions Guidebook: 510(k) & De Novo
This in-depth 510(k) & De Novo Guidebook will provide real-world case studies, tips and best practices directly from FDA and industry experts.
AdvaMed®’s Medical Innovation Agenda for the 119th Congress
AdvaMed®’s medtech priorities for the 119th Congress highlight opportunities to address the most important issues facing patients and the medical technology industry today.
State of the Nation 2025: Global Medical Device Recall Index Report
Download Sedgwick’s Global Medical Device Recall Report for key insights on compliance, regulations, and global recall trends. Members only.
Richardson Waiver Repeal: What it Means for Medtech
Sidley Austin, joined by HPA, will lead a program examining the impact of HHS repealing the so-called “Richardson Waiver”, including its history, how it could impact the activities of the…
AdvaMed® Congratulates Dr. Makary on his Confirmation as FDA Commissioner
Washington, D.C.– AdvaMed®, the Medtech Association, today released the following statement from President and CEO Scott Whitaker on the U.S. Senate’s confirmation of Dr. Marty Makary to serve as commissioner of…
The Medical Innovation Agenda for the 119th Congress
AdvaMed®’s medtech priorities for the 119th Congress highlight opportunities to address the most important issues facing patients and the medical technology industry today.
Connected Medical Devices
This white paper, “Connected Medical Devices”, explores the transformative impact of integrating Bluetooth Low Energy (BLE), mobile apps, cloud platforms, and AI/ML into medical devices. It highlights the benefits of…