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 Federal Device Distribution Legislation WG

To evaluate proposed federal legislation mandating licensure for device distribution activities; to develop industry consensus licensure positions and engage in public policy and advocacy activities to advance the consensus industry positions.

Contact: Christopher White

Ad Hoc Registries Working Group

To promote policies that facilitate the development of medical device registries that are efficient and effective in providing benefit to device manufacturers, the public, regulators, and the healthcare system. The working group monitors registry development worldwide and constantly reviews the AdvaMed Registry Principles document.

Contact: Zach Rothstein

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: Jamie Wolszon

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

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 Compliance Working Group

To advance a code of ethics in brazil and engage in compliance policy development.

Contact: Steven Bipes

Brazil Working Group

Contact: Steven Bipes

Broader Device Tax Coalition

Repeal the medical device excise tax.

Contact: Riley Swinehart

Central America Working Group

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: Ralph Ives

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: Ralph Ives

China Regulatory Working Group

To monitor and improve upon key regulatory issues in China.

Contact: Ralph Ives

China Volume-based Procurement (VBP) Subcommittee

Contact: Ralph Ives

Clinical Trials Working Group

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

Contact: Tara Federici

Colombia Working Group

To develop policy on Colombia regulatory and access issues.

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: Chandra Branham

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

Health Care Reform Working Group

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: Richard Price

Inpatient-Only List Transition to Outpatient Work Group

Contact: Chandra Branham

Inspections Subgroup

AdvaMed will compile a list of current issues with FDAÔø?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: Steven Silverman

Intellectual Property Working Group

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

Contact: Terry Chang

International Policy Working Group

Contact: Ralph Ives

International Special Reps

Support IBC.

Contact: Ralph Ives

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

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

Contact: Steven Bipes

Legal Affairs Group

Contact: Christopher White

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

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, ASC and physician payment recommendations for PPWG. Combines efforts on device payment under the Medicare hospital outpatient prospective payment system (OPPS) ambulatory surgical centers and physician fee schedule programs.

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

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

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

Contact: Chandra Branham

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

Puerto Rico Recovery Task Force

Coordinate and elevate company specific and industry-wide needs for recovery in Puerto Rico following the devastation of Hurricane Maria. The Task Force is a forum to exchange news, coordinate on mutual relief efforts, seek assistance and guidance from others, and to propose and consider outreach to the Federal and local government on industry requests and proposals to facilitate recovery.

Contact: Terry Chang

Quality of Life Products Working Group

To address reimbursement issues related to Ôø?quality of lifeÔø? 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: Janet Trunzo

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

Russia Working Group

Contact: Abby Pratt

Social Media Principles Team

Contact: Steven Silverman

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

WHO GMTA Working Group

Contact: Ralph Ives

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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