Committees & Working Groups

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

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

To develop recommendations for tax policy to encourage innovation and investment in small companies.

To monitor and address issues related to 3D printing. (Meetings: As needed)

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

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 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.

§ This task force supports the AdvaMed Digital Health Tech (DHT) Board Data Access & Interoperability Committee?s work on: § Developing a Data Access Code of Conduct Framework to build and maintain trust between health systems and medtech companies; § The development of a standard set of data-sharing templates between medtech companies and health care providers, including data types and access points required; § Governance models that support the use of the Data-Sharing Template; § Process, technical, and storage standards across industry and providers.

As a member of the Data Stewardship & Privacy Interest Group (DSPIG), you will receive the following: Updates about legislative and regulatory developments; Information about the development of AdvaMed policy positions, recommendations, and comments, along with opportunities to provide feedback; Invitations to volunteer for advocacy engagements; Invitations to participate in benchmarking surveys; and Invitations to educational webinars and virtual meetings.

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. Convenes regular peer-to-peer meetings concerning best practices; Conducts benchmarking surveys; Develops policy positions and guidance related to health care compliance. [In-house counsel & compliance professionals]

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)

To monitor and address issues pertaining to The Clinical Laboratory Improvement Amendments of 1988 (CLIA)  (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

Work group that connects AdvaMedDx member company government affairs professionals with the Association's advocacy and policy work.

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

This is a group of government affairs professionals who discuss cybersecurity issues and activities that are being considered by Capitol Hill.

Member company grassroots liaisons

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.

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.

To monitor and address regulatory issues affecting infusion pumps including FDA and international initiatives. (Meetings/Calls: As needed)

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.

AdvaMed will compile a list of current issues with FDA's facilities inspection process and work with FDA to (1) discuss inspectional issues and strategies to address these issues and (2) assist the Office of Regulatory Affairs (ORA) in its investigator training program. AdvaMed also will work on legislative/regulatory reforms to improve the FDA medical device inspection process.

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

Support IBC.

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

Working Group Membership: AdvaMed member company global executives, in house compliance officers, compliance lawyers and other professional in house staff having responsibility for company ethics compliance matters in Latin America.

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.

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 domestic and international regulatory and reimbursement issues of common concern to member companies in the ophthalmic sector. (Meetings/Calls: Quarterly)

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

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

To address FDA regulation of pacemakers, implantable cardioverter defribrillators and other issues associated with these devices. (Meetings/Calls: As needed)

To coordinate advocacy activity on payment and outcomes related legislation and regulation.

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 issues pertaining to personalized medicine. (Meetings/Calls: Quarterly)

To address FDA regulation of devices requiring a PMA. (Meetings/Calls: Every two months)

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.

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

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

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

To monitor and address issues related to UDI and spine, trauma tray and other devices distributed in trays (Meetings/Calls: weekly)

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 address statistical issues in FDA guidances and regulations and to provide statistical expertise and support to other AdvaMed working groups. (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 regulatory, payment and code issues in Taiwan as they arise.

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

This is a group of government affairs professionals who discuss issues related to price transparency and Capitol Hill.

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.

To address specific legal policy issues associated with innovative partnerships between providers and manufacturers.

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.