In the past 18 months, the FDA has outlined clear guidelines for designing, documenting, updating, and monitoring AI-powered ...
Finally, the terminology shift worth flagging is QMSR replacing the “Design History File” with “Design and Development File”, ...
New guidance issued by the US Food and Drug Administration (FDA) is intended to clarify the process of "marking" a medical device with a Unique Device Identifier (UDI). Under a final rule released in ...
The US Food and Drug Administration (FDA) on Thursday issued a final rule that significantly reduces record-keeping requirements for medical devices such as x-rays. The agency said the move will ...
The main market opportunities include navigating US regulatory pathways like 510(k), PMA, and DeNovo for medical device approvals. The modified 510(k) process encourages submission of new technologies ...
Key market opportunities lie in developing medical software and healthcare apps with a strong focus on safety, quality, and effectiveness. Leveraging AI/ML technologies, understanding clinical ...
FDA denies exemption request for radiology AI devices, requiring continued 510(k) premarket review to ensure safety and effectiveness.
The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices. Officials say the move is intended to speed innovation while maintaining ...
In November, the Food and Drug Administration (FDA) held a Digital Health Advisory Committee meeting where it considered treating artificial intelligence mental health chatbots as medical devices. As ...
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