Research & Policy Papers

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Our experts are continually producing new and valuable materials for the medtech community.

Research & Policy Papers
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Compliance

Newly Revised Code of Ethics

AdvaMed® has developed revisions to the  AdvaMed® Code of Ethics to address evolving compliance and legal standards, account for innovative value-based care arrangements, and incorporate additional provisions on risk areas specific to medical technology companies.

Resource / Diagnostics / Regulatory Affairs

Clinical Evidence for IVD Medical Devices

AdvaMed’s feedback on the CEIVD draft outlines targeted recommendations to improve clarity in clinical evidence expectations for IVD devices, including more precise terminology, alignment with global frameworks, and clearer distinctions between real-world data and evidence.

Resource / Ethylene Oxide

AdvaMed’s Comments on EPA Sterilization Emissions Standards

AdvaMed outlines recommendations to ensure EPA’s proposed ethylene oxide (EtO) emissions standards protect public health while maintaining access to life-saving medtech.
doctor chatting with patient

Resource / Coverage & Payment

Medicare Coverage Processes: An Analysis of Procedural and Resource Concerns

This report focuses on coverage for devices and issues related to procedural delays, the lack of transparency in Medicare’s National Coverage Determination process, the use of Coverage with Evidence Development, harmonizing with the FDA, and ensuring patient safety.
doctor wrapping a hand

Resource / Legal / Value-Based Collaborations

AdvaMed® Best Practice Guidance on Value-Based Arrangements

These arrangements to advance value-based care are designed to increase shared accountability among shareholders for quality of, access to and/or the total cost of care.
a doctor speaks with a patient showing them files

Blog / Health Access

Increasing Representative Enrollment In Clinical Research and Addressing Health Inequities

This document is intended to outline some of the potential considerations and possible approaches to help research sponsors improve inclusion of under-represented groups in clinical research.
two surgeons analyze hologram of a brain

Resource / Investor Relations / Small Business

New Strategies for Medtech Startups: Attracting Investment from Across the Innovation Ecosystem

Investment in early-stage medtech innovation can be critical in ensuring that patients have access to novel therapeutics and diagnostics.

More Resources

Coverage & Payment / Regulatory Affairs

AdvaMed® Comments on FDA-2016-D-1307 Communications with Payors

AdvaMed’s recent submission to the Food and Drug Administration (FDA) provides comments on the Agency’s revised draft guidance governing communications between drug and device manufacturers and payors, formulary committees, and…

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