Instead of making life easier for medical device companies, the FDA’s new wearables guidance makes the market more complex.

The FDA has entered into the federal register a new draft guidance pertaining to "software as a medical device" (SaMD).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 ...

Opinion: The Food and Drug Administration's updated guidance on wellness devices will help ensure that products are appropriately positioned in the market—while staying away from unsupported, ...

The Food and Drug Administration (FDA) has released guidance providing recommendations on what information should be included in a predetermined change control plan (PCCP) tailored to marketing ...

Simpler rules apply to less invasive hardware ...

The FDA has released a new draft guidance that outlines how developers should evaluate software used for the clinical management of patients. This software, called “software as a medical device,” is ...

In the document, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning-Enabled Device Software Functions," the FDA proposes to ...

To support the continued development and marketing of safe and effective medical devices enhanced by artificial intelligence, the U.S. Food and Drug Administration will offer marketing submission ...

AI is touching every industry, and healthcare is no exception: the global market size for healthcare AI, which was valued at $10.31 billion in 2023, is forecasted to reach $14.92 billion in 2024 and ...

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