Fierce Healthcare

FDA paves way for more consumer wearables to hit the market, eases regulation of AI-enabled devices

The Food and Drug Administration (FDA) updated its guidance on Tuesday to allow more wearables to fall into a general ...
JD Supra

FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions

On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance ...
JD Supra

FDA Issues Draft Guidances on AI in Medical Devices, Drug Development: What Manufacturers and Sponsors Need to Know

The FDA recently issued draft guidances for the use of AI in medical devices, drugs, and biologics. The guidances emphasize the need for comprehensive AI policies addressing risk evaluation, data ...
ConsumerAffairs

FDA relaxes rules for wearable health devices

The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices.
MobiHealthNews

FDA floats new draft guidance, created by international group, on software as a medical device

The FDA has entered into the federal register a new draft guidance pertaining to "software as a medical device" (SaMD). The guidance is presented as representing the FDA's current thinking on ...
Control Global

Medical device control system cyber incidents have injured and killed people

The Federal Drug Administration’s current cybersecurity requirements are not appropriate for addressing and avoiding medical ...
MD&M East

To Be or Not to Be (a Medical Device): FDA Vs. WHOOP

On July 14, 2025, FDA issued a warning letter to WHOOP, Inc., notifying the company that its marketing of Blood Pressure Insights (BPI) was neither cleared nor approved. FDA stated that BPI qualifies ...