Learn more about our Regulatory Affairs work.
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…
Per- and polyfluoroalkyl substances, known as PFAS, are a broad class of over 12,000 substances that are found in a variety of consumer, commercial and industrial products, including medical devices…
By Friday, March 1, the Environmental Protection Agency is expected to finalize its regulation for the ethylene oxide (EtO) sterilization of 20 billion, or half, of all medical devices in…
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…
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.
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.
Medical device manufacturers take seriously the need to continuously assess the security of their 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…
AdvaMed experts gave a presentation on how FDA regulates AI/ML in medical devices and how Medicare reimbursement policy is impacted by digital health technologies.
This carefully curated program will provide you with a comprehensive understanding of the current compliance framework.