Committees & Working Groups

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

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

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)

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.

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.

To facilitate recruitment, enrollment and retention of women in cardiovascular device trials. (Meetings/Calls: weekly)

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.

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

This team is developing training for industry representatives to all FDA device advisory committees.

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

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

Address global UDI implementation concerns.

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

Repeal the medical device excise tax.

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 improve China's regulatory and payment system for invitro diagnostic products.

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)

To develop policy on Colombia regulatory and access issues.

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

It is charged with addressing the range of coverage, coding, and evidence matters and making recommendations to PPWG.

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.

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

Work Group Membership: AdvaMed member company in house compliance officers, compliance lawyers and other professional in house staff having responsibility for company compliance matters.

To address the coverage and payment challenges within Medicare for private payers.

To address regulatory issues pertaining to blood glucose monitoring (Meetings/Calls: Quarterly)

To monitor and address issues pertaining to The Clinical Laboratory Improvement Amendments of 1988 (CLIA) (Meetings/Calls: As needed)

This 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)

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.

To focus on disposable devices.

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 monitor and participate in standards and regulatory activities aimed toward the use of electronic submissions systems worldwide. (Meetings/Calls: 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 streamline and harmonize the regulatory environment for medical technologies in the European market.

This work group will discuss payment for the use of Extended ECG monitoring under Medicare.

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

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.

To develop supporting site-neutral payment advocacy materials with a focus on imaging.

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)

Standing issue group charged with developing initial inpatient payment recommendations for PPWG.

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.

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.

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

To promote policies which ensure timely and appropriate levels of valuation for medical technology products.

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.

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

This is a group of companies interested in opioids related issues.

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

To monitor and address regulatory issues affecting spine products. Tara Federici is staff along with Richard Price. (Meetings/Calls: Weekly)

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.

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.

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 regulatory issues pertaining to PMA Submission Templates.  (Meetings/Calls: Every two months)

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.

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.

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.

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.

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 work to promote and secure fair, stable and transparent reimbursement and coverage policies.

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)

To address regulatory initiatives affecting computerized devices, medical information systems, and standalone software used in a medical setting.

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)

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.

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

To discuss issues related to Medicaid and Medicare coverage for telehealth technologies

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

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.

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.