FDA’s Breakthrough Devices Program: What It Is and How It Impacts Everyday People
The U.S. Food and Drug Administration’s (FDA) Breakthrough Devices Program is a voluntary initiative designed to expedite the development, assessment,…
Tag: FDA
First Meeting of FDA’s Digital Health Advisory Committee
The U.S. Food and Drug Administration (FDA) convened its inaugural Digital Health Advisory Committee (DHAC) meeting on November 20-21, 2024,…
Healthcare AI: FDA Urges Balance Between Progress and Patient Safety
The FDA’s role in regulating AI-based medical devices has evolved significantly since the agency first approved such a device in…
Understanding FDA’s Role in Regulating AI for Medical Products
New technologies are frequently hailed as transformative in healthcare, yet AI has exceeded even the loftiest expectations, emerging as a…
Food and Drug Administration (FDA): Regulating AI in Healthcare
Food and Drug Administration (FDA): Regulating AI in Healthcare The U.S. Food and Drug Administration (FDA) recognizes the transformative potential…
Understanding the FDA’s Strategy for Regulating AI in Medical Products
On March 15, 2024, the U.S. Food and Drug Administration (FDA) released a significant publication titled “Artificial Intelligence and Medical Products:…