
Committees & Working Groups
One of the best ways to become engaged in AdvaMed is through our committees and 100+ working groups. Each policy area has a number of working groups that focus on a variety of issues to address the increasing challenges facing medical device, diagnostic, and health IT companies today.
510(k) Working Group
To address regulatory initiatives that impact 510(k) submissions. (Quarterly meetings)
Contact: Khatereh Calleja
Accel Member Updates
Distribution List for regular Accel Member Updates: Accel Monthly Policy UpdateAccel Quarterly Advocacy Briefing
Contact: Patrick Brennan
Ad Hoc 3D Printing Working Group
To monitor and address issues related to 3D printing. (Meetings: As needed)
Contact: Jamie Wolszon
Ad Hoc Biocompatibility Working Group
To address issues with medical device biocompatibility testing requirements and work with FDA to ensure clarity and predictability regarding these requirements.(Meetings: Monthly/Quarterly)
Contact: Khatereh Calleja
Ad Hoc Working Group on Women in Cardiovascular Device Trials
To facilitate recruitment, enrollment and retention of women in cardiovascular device trials. (Meetings/Calls: weekly)
Contact: Tara Federici
AdvaMed All Member Coronavirus Task Force
Contact: Kyle Churchman
AdvaMed COVID-19 Supply Chain Task Force
Contact: Abby Pratt
AdvaMed Digital Working Group
To address regulatory policy issues affecting Software as a Medical Device (SaMD), e.g. mobile medical applications, web-based applications, Clinical Decision Support software, Medical Device Data Systems (MDDS). The affected technology is within the scope of this group regardless of the platform on which it is installed, e.g. medical device, smartphone, cloud based server. The technical aspects of SaMD are not in scope, e.g. risk management, cybersecurity, software error corrections.
Contact: Zach Rothstein
Advertising and Promotion Working Group
To address FDA's regulation of device manufacturers advertising and promotion activities. (Meetings/Calls: as needed)
Contact: Khatereh Calleja
Advisory Committee Industry Representative Training Team
This team is developing training for industry representatives to all FDA device advisory committees.
Contact: Steven Silverman
Africa Working Group
To advance AdvaMed’s Africa advocacy reducing patient barriers to medtech across the disciplines of trade, regulatory, access and ethics
Contact: Steven Bipes
ASEAN Working Group
to improvde regulatory coherence through effective adoption and implementation of the ASEAN medical device directive
Contact: Philip Agress
Automatic Identification (UDI) Working Group
To address regulatory and legislative initiatives that impact the application of UDI to medical devices and the transmission of data associated with UDI.
Contact: Zach Rothstein
Automatic Identification – Global UDI Subgroup
Address global UDI implementation concerns.
Contact: Zach Rothstein
Blood Working Group
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)
Contact: Janet Trunzo
Brazil Working Group
To advance AdvaMed’s Brazil advocacy reducing patient barriers to medtech across the disciplines of trade, regulatory, access and ethics
Contact: Steven Bipes
Broader Device Tax Coalition
Repeal the medical device excise tax.
Contact: Riley Swinehart
Central America Working Group
To advance AdvaMed’s Central America advocacy reducing patient barriers to medtech across the disciplines of trade, regulatory, access and ethics
Contact: Steven Bipes
Chief Medical Officers Work Group
To address quality, payment and other medical-device related issues in an environment of medical professionals.
Contact: Terry Chang
China Code and Compliance Task Force
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.
Contact: Terry Chang
China Diagnostic Working Group
To monitor and improve China's regulatory and payment system for invitro diagnostic products.
Contact: Ashley Miller
China Payment Working Group
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.
Contact: Ashley Miller
China Regulatory Working Group
To monitor and improve upon key regulatory issues in China.
Contact: Ralph Ives
China Volume-based Procurement (VBP) Subcommittee
Contact: Ashley Miller
Clinical Trials Working Group
To address regulatory and legislative initiatives that impact clinical trials. (Meetings/Calls: weekly)
Contact: Tara Federici
Colombia Working Group
To advance AdvaMed’s Colombia America advocacy reducing patient barriers to medtech across the disciplines of trade, regulatory, access and ethics
Contact: Steven Bipes
Combination Products Working Group
To improve the regulatory process for combination products. (Meetings/Calls: Quarterly)
Contact: Anita Nosratieh
Competitive Bidding/Inherent Reasonableness Work Group
Contact: Richard Price
Coverage and Coding Work Group
It is charged with addressing the range of coverage, coding, and evidence matters and making recommendations to PPWG.
Contact: Chandra Branham
Data Stewardship & Privacy Work Group
This working group has three overlapping areas of work: Policy and advocacy on state and federal legislation;Policy and advocacy on federal rulemaking by relevant agencies;Development of AdvaMed Health Care Data Stewardship Principles.
Contact: Andrew Fish
DDCG Planning Group
Group formed two times per year to faciliate planning for DDCG Spring and Fall meetings.
Contact: Christopher White
Device and Diagnostics Compliance Group (DDCG)
Work Group Membership: AdvaMed member company in house compliance officers, compliance lawyers and other professional in house staff having responsibility for company compliance matters.
Contact: Ethan Gumpert
Diabetes Payment Work Group
To address the coverage and payment challenges within Medicare for private payers.
Contact: Richard Price
Diagnostics Blood Glucose Monitoring Working Group
To address regulatory issues pertaining to blood glucose monitoring (Meetings/Calls: Quarterly)
Contact: Jamie Wolszon
Diagnostics CLIA Working Group
To monitor and address issues pertaining to The Clinical Laboratory Improvement Amendments of 1988 (CLIA) (Meetings/Calls: As needed)
Contact: Jamie Wolszon
Diagnostics Payment Work Group
This group addresses payment, coverage and coding issues related to in-vitro diagnostic products.
Contact: Tara Burke
Diagnostics Task Force
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)
Contact: Jamie Wolszon
Digital Technologies Payment Work Group
To discuss payment and coverage issues for the telehealth/telemonitoring/ehealth category of issues that are becoming increasingly important as care coordination and integrated delivery models are working to better address patient care in multiple settings.
Contact: Richard Price
Dx Antibiotics Resistance Work Group
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.
Contact: Kristina Shultz
Dx Global Health Working Group
Work group focused on global priorities for IVDs including WHO programs and related activities
Contact: Susan Van Meter
Dx Washington Representative
Work group that connects AdvaMedDx member company government affairs professionals with the Association's advocacy and policy work.
Contact: Susan Van Meter
e-Submissions Working Group
To monitor and participate in standards and regulatory activities aimed toward the use of electronic submissions systems worldwide. (Meetings/Calls: As needed)
Contact: Jamie Wolszon
Electromagnetic Compatibility Working Group
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)
Contact: Jamie Wolszon
European Regulatory Working Group
To streamline and harmonize the regulatory environment for medical technologies in the European market.
Contact: Joseph Gatewood
Evidenced-Based Value in Orthopedics Working Group
Contact: Richard Price
Extended ECG Monitoring Work Group
This work group will discuss payment for the use of Extended ECG monitoring under Medicare.
Contact: Richard Price
FDA Advocacy Work Group
To coordinate advocacy activity on regulatory issues and outcomes related to legislation.
Contact: Greg Crist
Germany Working Group
To coordinate with local technology industry to influence health reforms, including new DRG system, technology assessment process and funding for health care.
Contact: Joseph Gatewood
Global Reimbursement Policy Working Group
Contact: Joseph Gatewood
GMTA Regulatory Committee
To develop regulatory proposals/positions on behalf of GMTA that will be presented internationally.
Contact: Janet Trunzo
Government Affairs Cybersecurity Group
This is a group of government affairs professionals who discuss cybersecurity issues and activities that are being considered by Capitol Hill.
Contact: Greg Crist
Grassroots Liaisons
Member company grassroots liaisons
Contact: Hasan Shah
HCIR Credentialing Working Group
Working Group Membership: AdvaMed member company in house counsel, HR executives and other in house professionals having health care industry representative (HCIR) credentialing responsibilities.
Contact: Christopher White
Imaging Work Group
To develop supporting site-neutral payment advocacy materials with a focus on imaging.
Contact: DeChane Dorsey
India Ethics & Compliance Subgroup
This Subgroup is dedicated to addressing ethics and compliance issues in India.
Contact: Abby Pratt
India Executive Committee
Contact: Abby Pratt
India GA Subgroup
Contact: Ralph Ives
India IVD Subgroup
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.
Contact: Abby Pratt
India Regulatory Subgroup
This Subgroup is dedicated to addressing regulatory issues in India.
Contact: Abby Pratt
India Working Group
Contact: Abby Pratt
Infusion Pump Working Group
To monitor and address regulatory issues affecting infusion pumps including FDA and international initiatives.(Meetings/Calls: As needed)
Contact: Jamie Wolszon
Inpatient Hospital Payments Work Group
Standing issue group charged with developing initial inpatient payment recommendations for PPWG.
Contact: Kirsten Tullia
Inpatient-Only List Transition to Outpatient Work Group
Contact: Chandra Branham
Inspections Subgroup
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.
Contact: Jamie Wolszon
Intellectual Property Working Group
Work Group Membership: AdvaMed member company in-house counsel having IP responsibilities.
Contact: Terry Chang
International Policy Working Group
Contact: Ashley Miller
International Special Reps
Support IBC.
Contact: Ashley Miller
Italy Working Group
To work with local industry to improve the timeliness of payments for medical in Italy.
Contact: Joseph Gatewood
Japan Regulatory Working Group
To streamline and harmonize the regulatory environment for medical technologies in the Japanese market.
Contact: Philip Agress
Japan Reimbursement Working Group
To promote policies which ensure timely and appropriate levels of valuation for medical technology products.
Contact: Philip Agress
Korea Working Group
Contact: Joseph Gatewood
Latin America Access Working Group
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
Contact: Steven Bipes
Latin America Compliance Working Group
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.
Contact: Nancy Travis
Latin America Regulatory Working Group
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.
Contact: Steven Bipes
MedTech Investment Working Group
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.
Contact: Patrick Brennan
Mexico Working Group
To advance AdvaMed’s Mexico advocacy reducing patient barriers to medtech across the disciplines of trade, regulatory, access and ethics
Contact: Steven Bipes
Ophthalmic Devices Working Group
To address domestic and international regulatory and reimbursement issues of common concern to member companies in the ophthalmic sector.(Meetings/Calls: Quarterly)
Contact: Tara Federici
Opioids Work Group
This is a group of companies interested in opioids related issues.
Contact: Kirsten Tullia
Orthopedic Products Working Group
To address regulatory issues affecting orthopedic products.(Meetings/Calls: weekly)
Contact: Tara Federici
Orthopedic Spine Working Group
To monitor and address regulatory issues affecting spine products. Tara Federici is staff along with Richard Price. (Meetings/Calls: Weekly)
Contact: Richard Price
Outpatient PPS/Ambulatory Surgical Center Work Group
Standing issue group charged with developing initial outpatient and ASC payment recommendations for PPWG.
Contact: Chandra Branham
Pacemaker & Implantable Defibrillator Working Group
To address FDA regulation of pacemakers, implantable cardioverter defribrillators and other issues associated with these devices.(Meetings/Calls: As needed)
Contact: Khatereh Calleja
Payment Advocacy Work Group
To coordinate advocacy activity on payment and outcomes related legislation and regulation.
Contact: Amanda Walsh
Payment Policy Work Group
To analyze Medicare reimbursement policy and provide changes assuring patient access to technology.
Contact: Chandra Branham
Pediatric Working Group
To monitor and address issues related to pediatric device development and postmarket surveillance.(Meetings/Calls: every other week)
Contact: Tara Federici
Personalized Medicine and Molecular Diagnostics (PMMD) Working Group
To address regulatory issues pertaining to personalized medicine. (Meetings/Calls: Quarterly)
Contact: Jamie Wolszon
Physician Fee Schedule (PFS) Working Group
Standing issue group charged with developing initial physician payment recommendations for AdvaMed's Payment Policy Work Group ("PPWG").
Contact: Kirsten Tullia
PMA Submission Templates Subgroup
To address regulatory issues pertaining to PMA Submission Templates. (Meetings/Calls: Every two months)
Contact: Anita Nosratieh
PMA Working Group
To address FDA regulation of devices requiring a PMA.(Meetings/Calls: Every two months)
Contact: Anita Nosratieh
Postmarket Policy Working Group
To address regulatory and legislative initiatives that impact medical devices in distribution.
Contact: Zach Rothstein
Prior Authorization Work Group
The Prior Authorization WG will work to develop principles and promote key reforms needed to reduce prior authorization delays and physician burden, while enhancing patient care.
Contact: Kirsten Tullia
Public Affairs Coordinating Council
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.
Contact: Jim Jeffries
Quality of Life Products Working Group
To address reimbursement issues related to quality of life products that improve the lives of patients but are not necessarily lifesaving. Areas of focus for the group include (1) coverage from exchanges/private plans and standardization of coverage, (2) perception of medical necessity, (3) patient engagement and understanding of options and availability, and (4) new payment models.
Contact: Kirsten Tullia
Quality System Working Group
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.
Contact: Jamie Wolszon
Racial Disparities in Healthcare Core Team
Member companies and AdvaMed staff working on efforts to respond to racial disparities in health.
Contact: DeChane Dorsey
Radiation Therapy Global Committee
The RT Sector will strive to influence global government and healthcare thought leaders to increase patient access to radiation therapy.
Contact: Shandi Barney
Radiation Therapy Government Affairs Committee
The RT Sector will collaborate with Congress to develop policies that support innovation, maintain and increase patient access to radiation therapy.
Contact: Shandi Barney
Radiation Therapy Payment Work Group
The RT Sector will work to promote and secure fair, stable and transparent reimbursement and coverage policies.
Contact: Kirsten Tullia
Radiation Therapy Public Affairs Committee
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.
Contact: Shandi Barney
Radiation Therapy Regulatory Working Group
The RT Sector will work to shape regulatory environments to ensure predictable, efficient, and science-based policies and decision-making.(Meetings/Calls: Monthly)
Contact: Anita Nosratieh
Research & Development Forum
Contact: Andrew Fish
Software Working Group
To address regulatory initiatives affecting computerized devices, medical information systems, and standalone software used in a medical setting.
Contact: Zach Rothstein
Standards Working Group
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)
Contact: Jamie Wolszon
State Affairs Working Group
To oversee the Association's state legislative advocacy program.
Contact: Greg Crist
Statistics Working Group
To address statistical issues in FDA guidances and regulations and to provide statistical expertise and support to other AdvaMed working groups.(Meetings/Calls: TBD)
Contact: Khatereh Calleja
Substantiation Standards
Contact: Steven Silverman
Sunshine Implementation Working Group
Group Membership: AdvaMed member company in house counsel, government affairs professionals and other in house staff having responsibility for implementing the Physician Payments Sunshine legislation.
Contact: Terry Chang
Taiwan Working Group
To monitor regulatory, payment and code issues in Taiwan as they arise.
Contact: Kyle Churchman
Telehealth Payment Subgroup
To discuss issues related to Medicaid and Medicare coverage for telehealth technologies
Contact: Richard Price
Trade Advocacy Work Group (TAWG)
To coordinate advocacy activity on trade issues and related legislation and regulation.
Contact: Amanda Walsh
Transparency Strategy Group
This is a group of government affairs professionals who discuss issues related to price transparency and Capitol Hill.
UK Working Group
To work with local industry to promote access to innovative medical technologies and to increase the level of spending on medical technology.
Contact: Joseph Gatewood
US-EU Trade Initiative Task Force
Contact: Abby Pratt
Vascular Procedure Work Group
Contact: Richard Price
Washington Heads of Offices
To provide overall direction and coordination to the staff and member company Washington Heads of Offices.
Contact: Greg Crist
Washington Representatives
To provide overall direction and coordination to the staff and member company Washington representatives.
Contact: Greg Crist
Wound Healing & Tissue Regeneration Work Group
Promote adoption of favorable wound technology coverage and coding, and reimbursement policies, mitigate the impact of competitive acquisition programs on wound management reimbursement and promote the appropriate use of wound care technologies.
Contact: Chandra Branham
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