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Regulatory Affairs

Learn more about our Regulatory Affairs work.

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Government & Legislative Affairs / Regulatory Affairs

Federal Net Operating Losses: One Tax Reform Issue Patients Should Know

Well-crafted tax policy on NOLs spurs innovation in new life-saving treatments and cures; and as we continue to emerge from the pandemic, there is no time more important for the…

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Online

Breakthrough Device Designation: Understanding Regulatory and Reimbursement Implications Webinar

August 4, 2021
12:00 PM - 1:30 PM

ADVAMED EVENT — This timely webinar focused on the FDA breakthrough devices program and the implications for payment and coverage.

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Government & Legislative Affairs / Regulatory Affairs

FTC: When it Comes to the Medical Technology Industry – First, Do No Harm

As medtech and the health care system drive us closer to the pandemic’s end, reflexive and ill-conceived antitrust policy targeting medical technology companies risks thwarting innovation, foreclosing patient access to…

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Online

U.S. Health Care Enforcement: Priorities and Key Regulatory Developments Webinar

June 16, 2021
1:00 PM - 2:00 PM

Join us for our webinar with Sidley Austin to better understand the current health care enforcement landscape with the new administration.

Global & Trade / Government & Legislative Affairs / Regulatory Affairs / Supply Chain

AdvaMed® Encourages Administration to Prioritize Transport of Medical Supplies

President and CEO of AdvaMed® Scott Whitaker sent a letter to President Biden on behalf of the medical technology industry asking “the Administration to make the transport of medical supplies…

Global webinar
Online

Navigating China’s New Regulatory Policy: Order 739 Webinar

June 28, 2021
8:00 PM - 9:30 PM

Join us for our webinar with Sidley Austin and China Med Device for a comprehensive overview of China’s new regulatory policies.

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Government & Legislative Affairs / Regulatory Affairs

The Problems State Right-to-Repair Statutes Pose for Patients and Hospitals

The long-term implications of state right-to-repair laws could have devastating consequences for health care providers and their patients.

Government & Legislative Affairs / Regulatory Affairs / Supply Chain

AdvaMed® Encourages Administration to Consider Patient Needs as It Addresses Semiconductor Shortage

AdvaMed®, the world’s largest trade organization representing medical technology companies, wrote a letter to U.S. Department of Commerce Secretary Gina Raimondo “to strongly encourage the implementation of policies that ensure…

Coverage & Payment / Government & Legislative Affairs / Regulatory Affairs

38 House Democrats Join Call to Give Seniors Access to Life-Saving Medical Care

A large group of Democratic lawmakers is requesting that the Biden administration enact a finalized federal rule that would give seniors on Medicare access to life-saving medical treatments.

Coverage & Payment / Government & Legislative Affairs / Regulatory Affairs

ICYMI: Medical Experts, Lawmakers, and Innovation Funders Urge Administration to Grant Medicare Beneficiaries Expanded Coverage of FDA-Designated “Breakthrough” Technologies Through MCIT Rule

Thought leaders across the country are urging the Administration to enact the Medicare Coverage of Innovative Technology (MCIT) rule that was set to go into effect March 15 before it…

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