Artificial Intelligence in Medtech
Artificial intelligence has been in the spotlight recently, but it is not a new concept to the Food and Drug Administration (FDA) or the medtech industry. AI advancements in the…
Regulatory Affairs
Learn more about our Regulatory Affairs work.
Artificial Intelligence in Medical Technology Myths and Facts
Outlining the facts and dispelling myths will inform policymaking to avoid overlap with current regulations and preserve the broad capacity of innovation to help patients.
Principles for Artificial Intelligence in Medical Technology
This document provides the medical device industry’s foundational principles for artificial intelligence in medical technology. These principles will guide further innovations, policymaking, and regulations in AI-enabled medical technology.
AdvaMed® Medical Device Cybersecurity Foundational Principles
Medical device manufacturers take seriously the need to continuously assess the security of their devices.
AdvaMed® Urges FTC to Not Implement Right to Repair Policies for Medical Devices
AdvaMed, the MedTech Association®, submitted comments to the Federal Trade Commission in response to a request for public comment on rulemaking regarding “right to repair” policies. AdvaMed® and AdvaMed®’s Medical…
Managing Requirements – A Systems Approach to Medical Device Requirements for efficient and compliant design and development
Sunrise Labs outlines a systems approach to medical device requirements for efficient design and development..
Building Medtech Connections and Why They Matter
Scott Whitaker, president and CEO of AdvaMed®, recently chatted with Joe Mullings, chairman and CEO of The Mullings Group, about the impact of the medtech industry and the importance of…
Medtech Sterilization and Patient Care: The Critical Role of Ethylene Oxide
Ethylene oxide sterilization ensures billions of pieces of medical technology are sterile for patients in every medical setting, in surgical procedures from c-sections to knee replacements.
Op-ed: Risk, Regulation, and Reality Checks: The Example of Ethylene Oxide
According to a senior toxicologist in a RealClearPolicy op-ed, the EPA draws unreasonable conclusions about the health risks of the ethylene oxide used to sterilize medical technology.
AdvaMed® Position Statement Regarding Transition to National Reimbursement Codes
This AdvaMed® position statement is intended to provide clarity about the transition away from the acronyms NDC/NHRIC to NRC, including rationale and implications.