RFI: National Strategic Plan for Advanced Manufacturing Letter

AdvaMed opposes renewal of the medical device repair exemption, citing new legal and manufacturer evidence that the prior rulemaking record no longer supports renewal.

When is software not just software? That’s the question at the center of comments AdvaMed recently filed with the U.S. Copyright Office. At first glance, this may sound like a narrow dispute about medical device repair. In reality, it reflects a broader challenge facing a software-driven economy: how should the law treat software that is distinct from, but connected to, the products it supports?

AdvaMed urges OIG to modernize Anti-Kickback Statute and Beneficiary Inducements CMP rules with a clinical trial-specific safe harbor to provide greater clarity for reasonable participant remuneration and support arrangements.

Gain a focused overview of how to record intellectual property with CBP to stop counterfeit & grey market medical Devices at the border

The AdvaMed Medtech Compliance Workshop is a forum designed specifically for medtech compliance leaders and legal and other professionals with health care compliance responsibilities.

Join AdvaMed® and Porzio for this comprehensive compliance workshop to better understand the current medtech compliance framework.

WASHINGTON—AdvaMed, the MedTech Association®, the world’s largest medtech trade association, representing over 650 medical technology innovators, has filed an amicus curiae brief in the Walker v. Becton, Dickinson and Company and C. R. Bard, Inc. case now before the Georgia Court of Appeals, urging the Court to reverse a trial court ruling that allowed unreliable expert testimony on ethylene oxide (EtO) exposure.

AdvaMed® comment letter to the OIG’s recommends updates to safe harbors, value-based arrangements, & oversight to support value-driven healthcare.