Committees & Working Groups

To discuss and address regulatory issues related to the 510(k) Program. 

The AdvaMed Accel Board of Directors will provide oversight to Accel division and lead the execution of its strategic plan and prioritization of its policy goals. AdvaMed Accel will lead efforts in advocating for domestic and international regulatory and payment policies favorable to emerging companies, facilitating a policy environment conducive to capital formation and innovation, and providing educational meetings and networking opportunities for member company leaders and professionals.  

Distribution List for regular Accel Member Updates: Accel Monthly Policy Update Accel Quarterly Advocacy Briefing

All small and mid size company prospects.

Tell the story of MedTech?s contributions at all stages of cancer care, Strengthen alliances with patient and clinical advocacy organizations, Connect more effectively with an Administration that is making cancer a high priority, and Advance AdvaMed policy initiatives by demonstrating their value from an oncology perspective.

At the direction of the AdvaMed Board Ethics Committee, this Working Group has been established to update the AdvaMed Code of Ethics to explicitly incorporate DMEPOS suppliers within the Code’s scope. The group will work in collaboration with Katie Pawlitz, Partner at Reed Smith. The Working Group will meet on an ad hoc basis as needed throughout the Code revision process.

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.

This is a group of government and global affairs professionals who discuss tariff and tariff-related issues at both the global level and advocacy level. 

AdvaMedDx Executive Committee

AdvaMedDx Board

AdvaMedDx Board Substitutes

Work group consisting of the staff from AdvaMedDx Board companies.

AdvaMedDx Distribution List

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.

To coordinate advocacy activity on AI issues and related legislation and regulation.

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. 

The Task Force developing the KLP updates is made up of representatives from the APEC medtech associations listed below and industry compliance leaders, so it’s a great opportunity to engage with medtech stakeholders across the APEC region on key ethics and compliance topics.

The kickoff meeting for the Task Force will be on June 24 at two times to accommodate diverse time zones (8:00 AM U.S. Eastern Time / 8:00 PM Singapore Time, and 6:00 PM U.S. Eastern Time / 6:00 AM Singapore Time on 25 June).
Background materials will be circulated in advance of the kickoff meeting.

Time Commitment: The Task Force will meet 4-6 times (roughly once per month) through year-end.
Meetings will be facilitated by the Initiative’s Stakeholder Liaison team at Ethicist International. 

Central location for APG database.

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 advocate on a global basis for the highest ethical standards, promote the AdvaMed Code of Ethics, promote understanding of the Code, regularly evaluate the Code, identify key medical technology industry compliance issues and initiatives, and provide guidance on timely health care compliance issues

The mission of the Committee on Payment & Health Care is to promote the value of technology and assure appropriate access and reimbursement for medical technologies and diagnostics to improve patient care outcomes. Top issues include: developing and advocating for payment and coverage proposals that advance innovation, including coverage of breakthrough devices and diagnostic tests, and digital and diabetes technologies. AdvaMed also assists companies in leveraging AdvaMed’s Value Framework for medtech to help them to demonstrate their value and engage with payers.

To provide guidance to AdvaMed Staff in shaping the strategic direction of the organization.

To provide leadership for the activities that implement the technological and regulatory priorities as identified by the Board of Directors.

Management Sub-Committee of Board

 To improve market access for medical technology products and promote the value of medical technology, especially in AdvaMed's priority markets, i.e., Japan, Germany, France and UK.

Management Sub-Committee of Board responsible for recruiting, retention & non-dues revenue projects

Management Sub-Committee of the Board responsible for the screening & approval of board and chair-elect candidates and supervision of association policymaking and organizational governance processes.

Governing Body of the Association

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

To coordinate advocacy activity on the Ensuring Patient Access to Critical Breakthrough Products Act and related regulation.

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

Chairman?s Advisory Council is a standing Board Committee under AdvaMed's bylaws (Section 4). It is a committee of former AdvaMed Board members chosen by the current Board Chair. The Chair's Advisory Council role will be advisory and non-executive in nature and its duties, functions, and responsibilities will be determined by the Board.  

Share information, benchmark and develop policy responses on global code of ethics and anti-corruption compliance issues affecting the medical technology industry. Consists of member company Chief Compliance Officers with global responsibilities.

To set AdvaMed China strategic direction and priorities.

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 advise the China Board and China Working Groups and task forces on AdvaMed China issues and activities.

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.

The International Board Committee (IBC) requested that this Subcommittee (of the International Policy Group) be created to focus on implementing IBC-approved strategy of addressing China’s Volume-based Procurement policy. This Subcommittee is open to all interested members.

A subgroup of folks interested in working on AdvaMed recommendations for the Annual Public Meeting.

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)

Ad hoc working group/email list to coordinate Government Affairs efforts on competitive bidding.

Develops and executes regular benchmarking surveys on key compliance areas. These surveys go out to the broader Device & Diagnostics community, and remains available to AdvaMed members only.

Focuses on the measures and strategies companies employ to protect their assets, personnel, and operations from various threats. This includes physical security, such as access control and surveillance, as well as information security, risk management, and incident response.​

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.

FORUM: Serves as a forum for sharing and discussing data stewardship and privacy developments and trends.

POLICY REVIEW & POSITION DEVELOPMENT: Reviews 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.
Advocates for patient-centered policies and 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 research and innovation to improve patient care.

BENCHMARKING & BEST PRACTICES EXCHANGE: Development of AdvaMed Tools & Resources; Conduct benchmarking of data stewardship & privacy policies, department and program management, or other operational issues. Serves as a forum for sharing Best Practices (e.g., de-identified policies—drafts under development and current policies, training materials, and monitoring practices).

Group formed two times per year to faciliate planning for DDCG Spring and Fall meetings.

To discuss and address regulatory issues related to the De Novo Program.

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. 

Government affairs staff for members of the Diabetes ELG. Restricted access.

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)

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

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

Work group focused on discussing the development of communications plan designed to enhance awareness of the in vitro diagnostics industry as well as AdvaMedDx and its members’ collective successes and achievements beyond with trade, policy, regional and national media outlets and key public policy audiences.

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 issue-specific subgroup of the Digital Technologies Payment Work Group will consider coverage and payment pathways for DTx, focusing specifically on durable medical equipment and physician fee schedule benefit categories.  

This is the list for the DITTA Steering Committee

Share information on joint activities related to regulatory reliance

Share information on joint activities related to Unique Device Identifiers

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.

This issue-specific work group reviews pathology/lab coding applications being submitted to the AMA. (Requires execution of confidentiality forms before participation is allowed.)

To address regulatory issues pertaining to The Verifying Accurate Leading-edge IVCT Development (VALID) Act (Calls: Weekly / Meetings: As needed)

To address industry concerns regarding who may be affected by the imposition of requirements, through voluntary or regulatory standards, specifying electromagnetic emission and susceptibility limits and characteristics for medical devices. (Meetings/Calls: As needed)

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)

This issue-specific work group addresses payment and coverage issues related to products used in the treatment of end-stage renal disease and advocates for policy changes supporting new and innovative treatment technologies.

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

To coordinate advocacy activity on regulatory issues and outcomes related to legislation.

The purpose of the FDA strategy group is to provide members with updates on FDA organizational changes, new or updated policies/guidance/regulations, and new programs. Membership in this working group is open to individuals with a background in regulatory affairs who work on FDA-related regulatory issues.

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

MISSION & PURPOSE ·          Set Data Use, Stewardship, and Privacy Policy Priorities to guide the Association?s work based on direction from the AdvaMed Board of Directors (Board). ·          Steer AdvaMed?s Data Privacy, Data Stewardship, and Other Data Use Policy Development ·          The GCPOSC shall steer Data Use, Stewardship, and Privacy Benchmarking, Best Practices Exchange, and the Development of related AdvaMed Tools & Resources. ·          The GCPOSC will guide AdvaMed staff on ways to integrate these priorities across topics discussed at Data Stewardship & Privacy Working Group (DSPWG) and Data Stewardship & Privacy Interest Group (DSPIG) meetings.

Guides AdvaMed’s ethics and compliance engagements under the direction of the Board Committee on Ethics & Health Care Compliance. ​

To develop a strategy that supports regulatory convergence globally. Calls: Weekly

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

Consensus policies on global tendering issues.

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.

– Establish a regulatory, policy, and standards environment which enables the protection of device confidentiality, integrity, and availability to support patient safety and privacy;
– Advocate manufacturer-supported best practices to harmonize regulatory requirements and customer expectations;
– Provide manufacturers and healthcare systems increased clarity and harmonization to support efficient and effective application of standards and policies; and
– Coordinate, collaborate, and, where appropriate, align with the broader internal and external cybersecurity policy and standards development community.

AdvaMed Imaging members produce the software used by and for medical imaging devices. This includes traditional picture archiving and communication systems (PACS), software-as or software-in-a-medical-device (SaMD/SiMD) products (including AI/ML), and other software products that enable the creation, review, sharing, analysis, and display of medical images.
Enterprise Imaging aims to support the exchange of healthcare information through technical standards such as IHE, DICOM, and HL7 Version 2. It promotes interoperability, advocates for least-burdensome regulatory and legal requirements, and promotes key policies to better enable innovation in Health IT.

– Establish understanding of technology and relationships with key Congressional offices
– Develop or support legislative or regulatory proposals to address coverage and reimbursement challenges
– Promote value and awareness of technology through the media 

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 System charged with developing initial inpatient payment recommendations for PPWG.

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

The IPG addresses all relevant international issues of concern to members. Its purpose is to allow members to consider a range of specific issues, some of which may also be addressed in other working groups, and to raise new issues. In addition, if a specific policy issue cannot be resolved in a working group, the IPG provides an opportunity to seek a resolution before advancing to the International Board Committee.

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.

General Counsel or Chief Legal Officer of an AdvaMed member company (excluding Associate Members).

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.

A Task Force overseen by the AdvaMed Cybersecurity Workgroup focused on development of industry-proposed updates to the MDS2 Standard

Mailing list for members of the MDSAP Industry Group including association members from US, Australia, Canada, Brazil, and Japan.

This Task Force will focus on overall global issues relevant to the MDSAP RAC and program as a whole. The group will inform MDSAP Industry Group activities and positions. 

The Medtech CEO Roundtable, per AdvaMed governance, is a Board Advisory group composed of CEOs from AdvaMed's mid-sized companies, who provide input on key AdvaMed policies, explore market-shaping issues of interest and make recommendations for potential AdvaMed policy development, and benefit from networking and engagement in all AdvaMed activities. Membership is restricted and its members must be vetted before approval. Please see Greg Crist, Andrew Steiner, or Nicki Boros for more information.

Steering Committee for the annual MedTech Conference

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.

This a group of government affairs professionals who engage in political fundraising in DC and have asked to be sent invitations to PAC events hosted by members of the medtech community.

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

At the direction of the AdvaMed Board Ethics Committee, this Working Group has been established to develop model legislation that would expand formal recognition of the AdvaMed Code of Ethics within state laws. The group will review existing state frameworks, such as those in California, Connecticut, Massachusetts, and Nevada, that require companies to maintain compliance programs or marketing codes of conduct consistent with the AdvaMed Code, and will explore opportunities to advance similar recognition in other jurisdictions. The initiative is being undertaken in collaboration with Katie Pawlitz, Partner at Reed Smith. The Working Group will meet on an ad hoc basis as needed throughout the project.

Provide ongoing guidance, support and oversight of non-dues revenue related initiatives after implementation.

This working group will develop AdvaMed Comments over the next 60-90 days on the OIG Compliance Program Guidance for Pharmaceutical Manufacturers (which references the medical device industry) and the OIG General Compliance Program Guidance.

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

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

To ensure strategic development and implementation of policies that will advance worldwide access to the benefit of orthopedic medical technologies by identifying and resolving legal, regulatory and economic issues. Essential to our success will be the development of strong working partnerships focused on the resolution of common issues with government regulators, standards organizations and payor, provider, practitioner groups. (Meetings/Calls: Quarterly)

To support enhanced patient centricity in the medical technology community, AdvaMed® created a program to provide training, support and advice so its members can further their own patient engagement programs.

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 provide a forum for AdvaMed company scientists to discuss latest research and help assess emerging issues. (Calls generally occur the second Wednesday each month.) The PFAS Subgroup is specifically limited to company scientists (and only one per company). Companies are welcome to designate a scientist to the group.  All members are welcome to join the lead policy group, the Environmental, Health & Safety Awareness Working Group (EHS WG), to receive updates on PFAS matters.

To discuss and address regulatory issues related to the PMA Program.

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

The RT Sector will work to shape regulatory environments to ensure predictable, efficient, and science-based policies and decision-making. (Meetings/Calls: Monthly)

To address domestic and international regulatory, reimbursement, legal/compliance, and public and government affairs issues of common concern to member companies in the RT sector.

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

To discuss and address regulatory and policy issues affecting digital health devices (e.g., SaMD, SiMD, AI-enabled devices, Clinical Decision Support, and mobile medical apps)

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)

To oversee the Association's state legislative advocacy program.

To communicate with state medtech partners. This group is not designed for AdvaMed member participation.

To address statistical issues in FDA guidances and regulations and to provide statistical expertise and support to other AdvaMed working groups. (Meetings/Calls: TBD)

To coordinate advocacy activity on sterilization issues and related legislation and regulation. 

mission statement under development (Meetings/Calls: TBD)

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 issues in the area of Technology and Regulatory Affairs and to recommend new projects to the Technology and Regulation Board Committee.

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. 

To provide overall direction and coordination to the staff and member company Washington Heads of Offices.

To provide overall direction and coordination to the staff and member company Washington representatives.

To respond to WHO proposals regarding prequalification; recommend proposed improvements to the program.