Committees & Working Groups

To address regulatory initiatives that impact 510(k) submissions. (Quarterly meetings)

The AdvaMed COVID-19 Supply Chain Task Force was launched in March 2020 at the direction of AdvaMed's Board in response to the COVID pandemic. This group, which is comprised mainly of logistics and supply chain experts from AdvaMed member companies, shares information about COVID and non-COVID related disruptions, bottlenecks, shortages and other barriers to the flow of medical supplies and equipment. At the direction of this group, AdvaMed works with the Administration and Congress to advance policies that will support our members and improve the environment for the deployment of medical technologies throughout the public health emergency and beyond.

Member companies and AdvaMed staff working on efforts to respond to racial disparities in health.

To address FDA's regulation of device manufacturers advertising and promotion activities. (Meetings/Calls: as needed)

To advance AdvaMed's Africa advocacy reducing patient barriers to Medtech across the disciplines of trade, regulatory, access, and ethics

This group will work to develop reimbursement pathway frameworks for AI coverage and payment, accounting for different types of AI products.

This subgroup of the AdvaMed Diagnostic Payment Work Group (DPWG) will work to develop recommendations to the government for improving payment and coverage for tests that further antimicrobial stewardship. 

to improve regulatory coherence through effective adoption and implementation of the ASEAN medical device directive

To address issues with medical device biocompatibility testing requirements and work with FDA to ensure clarity and predictability regarding these requirements. (Meetings: Monthly/Quarterly)

To address the regulatory and technology issues affecting blood products that require technical input including FDA product review, manufacturing, and compliance issues. (Meetings/Calls: As needed)

To advance AdvaMed?s Brazil advocacy reducing patient barriers to medtech across the disciplines of trade, regulatory, access and ethics

To advance AdvaMed?s Central America advocacy reducing patient barriers to medtech across the disciplines of trade, regulatory, access and ethics

Convene medtech compliance members and stakeholders in China to discuss contemporary compliance issues and steer AdvaMed's compliance program in China. In 2021, the Task Force will review and modernize as necessary the China Code of Ethics to align with the 2020 AdvaMed Code of Ethics.

To monitor and advocate industry positions in China's developing payment and reimbursement systems. Current Projects: Working with Chinese health officials to ensure appropriate value of technology in the new Centralized Tendering program; arranging education programs for Chinese reimbursement officials to share international experience.

To monitor and improve upon key regulatory issues in China.

To address regulatory and legislative initiatives that impact clinical trials. (Meetings/Calls: weekly)

This standing workgroup will serve as a forum to monitor and respond to policy developments from CMS in consideration of modernizing approval processes and coverage. Meeting bi-weekly, members will engage in informal discussions, share insights, and coordinate industry responses to CMS actions.

This standing work group will monitor, discuss, and work to improve CPT, and HCPCS code processes.

To advance AdvaMed?s Colombia America advocacy reducing patient barriers to medtech across the disciplines of trade, regulatory, access and ethics

To improve the regulatory process for combination products. (Meetings/Calls: Quarterly)

The AdvaMed Cybersecurity Working Group is a consortium of medical device industry professionals focused on improving Cybersecurity in the medical device ecosystem to protect patient safety and sensitive data.

MISSION & PURPOSE Data Privacy & Stewardship Policy Forum – The Data Stewardship & Privacy Working Group (DSPWG) shall serve as a forum to share and discuss data stewardship and privacy developments and trends.  Policy Position Development ? Review data privacy, data stewardship, or broader data use legislation, proposed rules, and other policy proposals impacting the medical device industry to develop AdvaMed positions and recommendations. Advocate for Patient-Centered Data Stewardship & Privacy Policies – Speak with a unified voice to drive appropriate, simplified statutory and regulatory regimes that enable the highest quality patient care while also meeting patients? expectations concerning appropriate controls in a framework that allows for continued life sciences research that further innovation to improve patient care. Benchmarking, Best Practices Exchange, and Development of AdvaMed Tools & Resources ? Conduct benchmarking of data stewardship & privacy policies, department and program management, or other operational issues. The Working Group shall serve as a forum for sharing Best Practices [e.g., de-identified policies (drafts under development & current), training materials, and monitoring practices] MEMBERSHIP RESTRICTION E-sign Commitment to Contribute to Policy Development, Benchmarking, and Sharing Best Practices – Contact the staff lead for more information.

To address regulatory de novo issues. (Meetings/Calls: As needed)

The group promotes medical technology industry compliance initiatives, identifies and shares best compliance practices, and works to educate individuals within the industry on legal and regulatory developments related to medical device and health care compliance issues. 

This issue-specific work group addresses coverage and payment barriers that limiting Medicare beneficiary access to advanced diabetes technologies and makes recommendations for eliminating these barriers.

To address regulatory issues pertaining to medical devices important to diabetes patients, including blood glucose monitors, continuous blood glucose monitors, and insulin pumps (Meetings/Calls: As needed)

This standing work group addresses payment, coverage and coding issues related to in-vitro diagnostic products.

To address the global regulatory and technology issues affecting Diagnostics that require technical input including FDA product review, manufacturing, and compliance issues, CLIA, the IVD Directive and Canadian regulation. (Meetings/Calls: Quarterly)

This standing work group proposes and advocates for changes to Medicare's regulatory policies to improve coverage and payment for digital technologies and/or technologies with digital components.

This standing work group responds to policy changes proposed by CMS to Medicare's durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) benefits as well as payment policies established for these benefits under the Competitive Bidding Program.

Work group focused on promoting the use of quality diagnostic tests, essential tools in addressing the crisis of AMR, by facilitating patient access to appropriate and timely diagnostics tests, and driving innovations in new diagnostics.

Work group focused on global priorities for IVDs including WHO programs and related activities

To provide a forum for AdvaMed members to consider EHS issues of interest to the general membership and to keep them apprised of developments; to identify EHS issues that may require advocacy efforts by AdvaMed; and to make strategic recommendations to AdvaMed's Board of Directors. (Meetings/Calls: As needed)

To streamline and harmonize the regulatory environment for medical technologies in the European market.

To coordinate with local technology industry to influence health reforms, including new DRG system, technology assessment process and funding for health care.

To promote policies which ensure timely and appropriate levels of valuation and improved access for medical technology products in global markets.

To develop regulatory proposals/positions on behalf of GMTA that will be presented internationally.

Group Purchasing Entities (GPE) Working Group – develops policy proposals to address GPEs, which are GPO-like entities where the GPE Members wholly own or share common ownership with the GPE and the GPE charges administrative fees exceeding the GPO Safe Harbor’s 3%.​

Working Group Membership: AdvaMed member company in house counsel, HR executives and other in house professionals having health care industry representative (HCIR) credentialing responsibilities.

This Subgroup is dedicated to addressing ethics and compliance issues in India.

AdvaMed's Indian Executive Committee (ExCom) is comprised of the senior most representatives (usually CEO or Managing Directors) of our member companies in India. This group provides high level and strategic guidance of our advocacy initiatives in India.

Appointed by their respective ExCom member, our India based GA group is comprised on government affairs, public policy and regulatory professionals who help guide and provide input to our day to day advocacy activities in India.

This Subgroup is dedicated to addressing health economics, pricing and reimbursement issues in India.

The AdvaMed India IVD Subgroup tracks regulatory and policy developments In India to identify challenges that impact the IVD industry. Recent initiatives include the development of an Essential Diagnostics List and the new Medical Device Rules 2017. AdvaMed works with members to assign priorities and resolve IVD related issues through meaningful engagement with the Government of India and other relevant stakeholders including the US Government WHO and other likeminded associations.

This Subgroup is dedicated to addressing regulatory issues in India.

This standing work issue group proposes and advocates for changes to Medicare's regulatory policies to improve coverage and payment for medical technologies under the Hospital Inpatient Prospective Payment Systemcharged with developing initial inpatient payment recommendations for PPWG.

Work Group Membership: AdvaMed member company in-house counsel having IP responsibilities.

Support IBC.

To work with members and the Italian trade association to track and provide support on addressing Italy's payback issues

To work with local industry to improve the timeliness of payments for medical in Italy.

The LatAm Access Working Group advances AdvaMed?s LatAm regional access work including a priority on the implementation of value-based care and value-based procurement, payment, reimbursement, health technology incorporation

The LatAm Regulatory Working Group advances AdvaMed?s LatAm regional regulatory work including a priority on the implementation of foundational good regulatory practices and medical device specific regulatory convergence, working in close collaboration with the Inter-American Coalition for Regulatory Convergence ? Medical Technology Sector.

Provides a forum for in-house litigation counsel of AdvaMed member companies to build collegial relationships and exchange information, experiences, and best practices. They help identify issue areas to be proactively addressed by AdvaMed and advises AdvaMed on how particular issues may affect member companies.​

The Litigation Reform Task Force is responsible for coordinating, drafting, and advancing organizational positions related to Civil Justice and Litigation Reform. The task force supports the association’s overall legal and policy objectives by monitoring emerging legislative, regulatory, and judicial developments and identifying areas where organizational engagement may be appropriate.

This issue-specific work group discusses payment for the use of Extended ECG monitoring under Medicare.

This group includes investor members and active member company representatives in business development, strategy, and corporate venture, as well as fundraising CEOs of small companies. It holds quarterly meetings to address issues and policies impacting MedTech innovation and investment. It organizes partnering events and receptions at investment and industry conferences and promotes networking, business development, and fundraising opportunities.

To advance AdvaMed?s Mexico advocacy reducing patient barriers to medtech across the disciplines of trade, regulatory, access and ethics

To address regulatory issues affecting orthopedic products. (Meetings/Calls: weekly)

This issue-specific work group addresses regulatory issues affecting reimbursement for orthopedic products.

This standing work group is used to discuss emerging issues, make recommendations on AdvaMed positions on important issues, and support the Payment and Health Care Delivery Department's strategic priorities.

To monitor and address issues related to pediatric device development and postmarket surveillance. (Meetings/Calls: every other week)

To address regulatory and legislative initiatives that impact medical devices in distribution.

To exchange communications strategies and messages and to coordinate activities so as to maximize the communications power of the medical technology industry in support of patient access to medical technology.

To address and promote the interests of the industry, both domestically and internationally, in quality assurance and regulatory compliance issues related to the development, manufacture, installation, distribution and service of medical devices.

This issue-specific group will focus on CMS quality reporting programs, alternative payment models, and payment demonstration projects. This group will highlight the critical role of medtech in delivering high-quality care and provide a forum for collaboration and industry response.

The RT Sector will strive to influence global government and healthcare thought leaders to increase patient access to radiation therapy.

The RT Sector will collaborate with Congress to develop policies that support innovation, maintain and increase patient access to radiation therapy.

The RT Sector will strive to increase awareness, understanding and appreciation of the value of radiation therapies in the U.S. and around the globe.

This issue-specific work group promotes adoption of favorable wound technology coverage and coding, and reimbursement policies. 

Monitor and work with FDA to maximize the use of standards in product submissions. Coordinate and encourage AdvaMed involvement in standards issues. (Meetings/Calls: Monthly)

Develops comments and policy guidance concerning the implementation of / amendments to the Physician Payments Sunshine provisions of the Affordable Care Act/ Open Payments Program. [In-house Compliance & Gov’t Affairs professionals]

To monitor regulatory, payment and code issues in Taiwan as they arise.

To address regulatory and legislative initiatives that impact the application of UDI to medical devices and the transmission of data associated with UDI.

To work with local industry to promote access to innovative medical technologies and to increase the level of spending on medical technology.

Tara Burke and Amber Stock will lead this issue-specific work group will work to develop principles and promote key reforms needed to reduce prior authorization delays and physician burden, while enhancing patient care.

Focused on modernizing the Anti-kickback Statue (AKS) Safe Harbors (SHs) to enable manufacturer engagement in more comprehensive, patient-centric VBAs, in a simpler, less time-consuming, and less costly fashion, through new, value-based specific and modernized AKS safe harbor regulations.

This issue-specific work group reviews public and private plan coverage and payment issues related to vascular procedures.