Providers’ Insights Shaping MedTech Go-to-Market Strategies
Uncover pivotal medtech go-to-market insights in our free webinar. Explore healthcare leaders’ views on industry trends, investments, and vendor interactions.
Regulatory Affairs
Learn more about our Regulatory Affairs work.
Medtech Sterilization and Patient Care: The Critical Role of Ethylene Oxide
Ethylene oxide sterilization ensures billions of pieces of medical technology are sterile for patients in every medical setting, in surgical procedures from c-sections to knee replacements.
Op-ed: Risk, Regulation, and Reality Checks: The Example of Ethylene Oxide
According to a senior toxicologist in a RealClearPolicy op-ed, the EPA draws unreasonable conclusions about the health risks of the ethylene oxide used to sterilize medical technology.
AdvaMed Position Statement Regarding Transition to National Reimbursement Codes
This AdvaMed position statement is intended to provide clarity about the transition away from the acronyms NDC/NHRIC to NRC, including rationale and implications.
AdvaMed Welcomes EPA Extension of Comment Period for Complex Medtech Sterilization Regulations, Says There’s “Not Nearly Enough” Time to Review Proposals Critical to Public Health
AdvaMed, the Medtech Association, today welcomed the U.S. Environmental Protection Agency (EPA) extension of 15 more days for public comment on two proposed updates to regulations governing the use of…
FDA’s Dr. Califf Calls for Diagnostic Regulatory Reform, a Long-Time AdvaMed Priority
WASHINGTON, D.C. – Following a Congressional hearing on “Preparing for and Responding to Future Public Health Security Threats,” AdvaMed, the Medtech Association, released a statement from President and CEO Scott Whitaker echoing the…
Clinical Trial Site Budgeting –Risk Mitigation or Budget Control?
Join NAMSA for a webinar that will highlight clinical trial site budgeting as both a risk mitigation strategy and an approach for sponsors to standardize site costs.
Fact Sheet: EtO Sterilization Prevents Infection
Each year in the U.S., ethylene oxide sterilizes 20 billion medical devices, which are critical to preventing serious, even life-threatening, infections.
AdvaMed’s Medical Innovation Agenda for the 118th Congress
AdvaMed’s medtech priorities for the 118th Congress highlight opportunities to address the most important issues facing patients and the medical technology industry today.
China: Key Regulatory Changes from 2022 and Look Ahead to 2023
Get the latest on NMPA’s updated guidance for the clinical evaluation of medical devices.