The FDA’s Action Plan for AI-ML Based Software as a Medical Device

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 medtech industry are playing a major role in improving patients’ lives through innovative care, reduced healthcare costs, and improved patient outcomes.

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 the United States each year. AdvaMed President and CEO Scott Whitaker released the following statement:

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 medtech industry are playing a major role in improving patients’ lives through innovative care, reduced healthcare costs, and improved patient outcomes.

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 Imaging division, in comments, outlined concerns regarding the impact of these policies as they relate to medical devices regulated by FDA.