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Main Issues

Regulatory Affairs

  • Like FDA, AdvaMed believes that product quality goes beyond compliance with current quality regulations. Instead, our goal is to partner with FDA to find design, production, and distribution practices that enhance medical device quality. We work towards this goal through efforts that include supporting FDA initiatives and by developing and providing resources and training on key principles of device quality.

  • The subjects below relate to premarket, postmarket, and quality topics. They are dynamic and closely watched by regulators, industry, and other stakeholders. We engage on these subjects through written submissions, in‑person discussions, and other communication channels.

  • After the FDA conducts its premarket review of a medical device, the manufacture and performance of the device are tightly controlled and monitored through a series of postmarket requirements. FDA’s postmarket requirements encompass every aspect of a device’s manufacture – from production and processing to packaging, distribution and use.

  • Proper servicing of complex, life-saving and life-sustaining medical devices is vital to their safe and effective functioning and the safety of patients and device users. 

  • CDRH advisory committees provide independent, professional advice from outside experts on the development, safety and effectiveness, and regulation of medical devices.  Going before an advisory committee can be a make-or-break moment for a device sponsor. Industry representatives (IRs) to these meetings play a critical role, helping to assure that these meetings focus on device safety and effectiveness and the issues under discussion.  

  • Ethylene Oxide (EtO) gas is the most common way to sterilize medical devices, a process which is critical for preventing infections and ensuring patients have safe surgeries and medical treatments.

  • Safety, effectiveness, and quality are the watchwords of the medical device industry, and companies commit time and expertise to ensure that their devices perform properly and serve patient needs. This commitment starts at the earliest design phase and continues through the development, manufacturing, and distribution of a device.

Payment & Health Policy

  • The Affordable Care Act included several new Medicare payment system reforms designed to improve coordination and collaboration among physicians and other healthcare providers. AdvaMed and its team of policy experts study these changes and determine their impact on patients, future medical innovation and our member companies.

  • Medicare covers health care items and services, including medical devices and diagnostic tests, for almost 50 million Medicare beneficiaries. In most cases, local contractors, called Medicare Administrative Contractors (or MACs) – the entities that process and pay Medicare claims –make coverage decisions, as long as those decisions do not conflict with a national policy. In some cases, Medicare develops a National Coverage Determination (NCD) for an item or service that applies to all Medicare beneficiaries that meet certain criteria for coverage.

  • The Payment & Policy Review is a new monthly communication from AdvaMed’s Payment and Health Care Delivery Policy Department that provides a short summary of important activities, reports, letters, meetings, etc. that relate to Medicare payment, coverage and quality issues.

  • AdvaMed’s Value Initiative is designed to provide stakeholders across the health care spectrum – patients, providers, payers, innovators etc. – with tools to objectively determine the value of a medical technology or diagnostic test and the evidence needed to support its use.


  • The AdvaMed Physician Service Market Analysis Report provides a resource for members to access detailed reports from data sets provided by CMS. The reports provide key Medicare Part-B service utilization and payment for a physician HCPCS code(s) to help members identify strategic opportunities in the market.

State MedTech Alliance

  • The State Medical Technology Alliance (SMTA) is a consortium of state and regional trade associations representing their local  medical technology companies.  SMTA’s mission is to collectively support the medical technology industry on the local, state and national levels by fostering a collaborative environment through sharing of best practices, promoting the industry, and advocating for public policies that support innovation.


  • Full repeal of the medical device excise tax is a clear win for American patients, American workers, and the American health care system.

Global & Trade

  • China presents the most significant growth market for the medical device industry today and for the foreseeable future.  AdvaMed's China initiatives increase opportunities for the industry in China while, at the same time, supporting China's long-term development goals.  Specifically, AdvaMed works with China's government and private sector to promote the value of medical technologies while advocating a fair and level playing field for all manufacturers.

  • Japan is in the midst of a two-year reimbursement cycle which will culminate in the determination of the rules it will use to adjust reimbursement prices in 2014. A key concern is Japan’s plan to adopt some form of health technology assessment (HTA) as a cost containment mechanism.

  • AdvaMed's Global Strategy and Analysis Department is seperated by country and issue. This contact list serves a directory.

  • America’s medical technology industry creates life-saving and life-enhancing treatments and cures that drive efficiencies and cost savings in the health care system while generating high-quality jobs that contribute to economic growth.

  • Ranking among the 20 top healthcare markets globally, India is expected to remain one of the fastest growing medical device markets over the next five years driven by emerging policies and initiatives, patient demographics and the expectations of India's rapidly growing middle-class. In addition to opportunities, however, there remain significant challenges, and AdvaMed is committed to working with public and private sector stakeholders to help bring advanced medical technologies to Indian patients.

  • As we continue to assess and respond to a crisis that continues to evolve, AdvaMed’s objective is to pool and disseminate industry knowledge, and share developments among our membership. Given the magnitude of the outbreak and the many moving pieces, AdvaMed has assembled a coronavirus task force. 


  • Working with nearly 300 in-house lawyers from member companies, AdvaMed’s Committee provides legal direction and leadership to ensure a legal environment that fosters medical technology innovation.

  • AdvaMed works to facilitate ethical interactions between companies and health care professionals (HCPs) globally. Ethical interactions enhance patient access to the safe and effective use of medical technologies by ensuring appropriate training of HCPs by companies.

  • The Affordable Care Act included several new Medicare payment system reforms designed to improve coordination and collaboration among physicians and other healthcare providers. AdvaMed and its team of policy experts study these changes and determine their impact on patients, future medical innovation and our member companies.

  • AdvaMed and MedTech Europe have developed joint compliance guidance and tools on Distributor Relations as part of an ongoing commitment to provide ethical guidance on appropriate industry interactions. We believe clear, established compliance programs will safeguard the integrity of medical decision making and promote further public confidence in our industry.

  • AdvaMed collaborated with AORN and the AHA to provide clinically based recommendations to support health care organizations and medical device representatives when resuming elective procedures--the Joint Statement: Re-entry Guidance for Health Care Facilities and Medical Device Representatives.  The recommended framework calls for hospitals to be the primary provider of personal protective equipment (PPE) to control for potential contamination, so that PPE is prioritized to providers where it is most needed. The guidance accounts for crisis capacity situations by allowing for company reps to be the back-up providers of their own PPE for emergency procedures. The guidance also recommends against COVID-19 diagnostic testing of asymptomatic reps, so that diagnostic testing resources can be prioritized for patients, symptomatic health care workers, and those with known or suspected exposures, consistent with CDC and other clinical guidelines.

  • We understand the pressing need to ensure access to high-quality, life-saving medical technology for patients in India, in the most affordable and efficient manner possible. To advance toward this goal, we share a commitment to and fundamental belief in operating with the highest standards of ethics and integrity. The companies listed here have Ethics and Compliance teams dedicated to communicating and enforcing clear standards of conduct for their employees and distributors. If there are gaps, concerns or observations, we welcome information via the compliance hotlines, websites, and/or contacts listed here.

  • Physician-own distributorships, or "PODs," include device companies and distributors that offer substantial equity positions to physicians, in some cases, selected because collectively they are in a position to generate a substantial amount of business for the entities through ordering (or influencing orders for) devices sold or manufactured by the company. In a March 26, 2013 Special Fraud Alert, the U.S. Department of Health and Human Services Office of Inspector General (OIG) notes that the POD business structure is inherently suspect, and cites OIG's 2006 correspondence with AdvaMed on the issue.

  • In partnership with the National Association of Manufacturers, AdvaMed members have free access to the Manufacturers’ Compliance Institute (MCI), which provides prompt, complimentary answers to questions regarding compliance issues from experienced attorneys working with top-tier legal counsel.

  • The U.S. health care system is transitioning from a fee-for-service and fee-for-product (volume-based) model to value-based paradigm to deliver more coordinated, high-quality, affordable health care.

    Value-based arrangements – also referred to as results-based, outcomes-based, or performance-based payment arrangements – may condition payment or modify pricing for health care items or services based upon a clinical, economic, and / or patient-experience outcome, to increase shared accountability for both quality and the total cost of care.

Ethics & Compliance

  • While the AdvaMed Code of Ethics has long set the standards for ethical interactions between health care professionals and member companies, we’re presenting an update in 2020 that reflects today’s world.

    As leaders in the MedTech community, it is our role to clarify and distinguish compliance standards as we continue our commitment to collaborative relationships, business integrity and life-changing innovation.

  • AdvaMed and its member companies work to facilitate ethical interactions between companies and health care professionals (HCPs) through global distributor capacity building programs, multi-national cooperatives and in-country initiatives.

  • At the Accel Center for Ethics (ACE), smaller companies are provided the tools and resources needed to adopt the AdvaMed Code of Ethics and implement its provisions to help ensure effective compliance.

  • The AdvaMed Global Distributor Center offers MedTech distributors in-person and online opportunities for compliance guidance, training and registration, including the Global Distributor Compliance Toolkit. 

  • To empower medical technology distributors with the tools and resources needed to build and implement an effective compliance program, AdvaMed and its member companies created a comprehensive Global Distributor Compliance Toolkit for use by all organizations in the global medical technology supply chain.

  • The AdvaMed Code Certification Center is open to both AdvaMed member and non-member MedTech companies to sign on to the code and obtain a certification logo to adopt, proudly display and reap the benefits of Code certification.

Ethylene Oxide Sterilization and Medical Devices

Board-Approved Principles

  • From time to time, AdvaMed adopts principles on a specific issue that provide summary information and convey the Association’s views on relevant policy matters and/or best practices. These principles are approved by the AdvaMed Board of Directors and serve as guidelines for Association member companies.