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Regulatory Affairs / VALID Act

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…

Government & Legislative Affairs

AdvaMed® to CMS: “Patients Are Still Waiting—But We’re Encouraged Congress No Longer Wants to Wait”

AdvaMed, The Medtech Association®, today called on the Biden Administration to implement a proposal to create a predictable pathway to national Medicare coverage for breakthrough medical technologies. The announcement comes…

Ethylene Oxide

EPA Analysis: “EPA Does Not Have Methods to Estimate How Long [EtO Sterilization] Facilities Might Close”

AdvaMed, The Medtech Association®, urges the Environmental Protection Agency (EPA) to heed concerns of medtech supply shortfalls under its proposed requirements on ethylene oxide (EtO) sterilization and consider the effects…

Ethylene Oxide

Medtech Leaders Testify Before EPA on Safety, Critical Role of Ethylene Oxide Sterilization in Public Health

AdvaMed®: “We place the highest priority on the safety of our communities, employees, and the millions of patients we serve.” WASHINGTON, D.C. – This week, medtech leaders from across the country…

Radiation Therapy

New Poll Finds Strong Support for Radiation Therapy in War Against Cancer

Today, AdvaMed, The Medtech Association®, released the findings of a new national poll on radiation therapy and cancer treatment revealing broad support for greater federal investment in the proven cancer…

Small Business

AdvaMed® Calls on Congress to Reform Tax Code to Support Small Businesses

Following the introduction of the bipartisan American Innovation and Jobs Act in the U.S. Senate and its House companion the American Innovation and R&D Competitiveness Act, AdvaMed, The Medtech Association®,…

Ethylene Oxide

AdvaMed® Calls for Extended Period for EPA’s Proposed Rules Governing EtO Sterilization

AdvaMed, The Medtech Association®, today called upon the U.S. Environmental Protection Agency (EPA) to double the time it will allow for public comment on two proposed updates to regulations governing…

Global & Trade

AdvaMed®, Department of Commerce Partner to Secure EU MDR Extension

AdvaMed, The Medtech Association®, working alongside the Department of Commerce’s International Trade Administration, advocated for and secured the recently implemented transition extensions for certifying medical devices in the European Union…

Ethylene Oxide

AdvaMed® Responds to Proposed Rules Governing Ethylene Oxide’s Role in Sterilizing Medtech

The Environmental Protection Agency (EPA) today released its proposed rule regulating ethylene oxide (EtO) sterilizers of medical technology and other commercial uses through the National Emission Standards for Hazardous Air…

Legal

AdvaMed® Comments on the FTC’s Proposed Rule Banning Non-Compete Clauses in Contracts with Workers

AdvaMed, The Medtech Association®, recently commented on the FTC’s proposed rule that would ban employers from imposing or enforcing non-compete clauses in contracts with certain workers. AdvaMed® opposes the FTC’s vastly…

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