FDA revised guidance documents for low-risk wellness products and clinical decision software, clarifying regulatory ...

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical ...

Medtech developers incorporating AI or machine learning into medical devices need to recognize if and how FDA will regulate ...

Opinion: In response to the FDA's updated cybersecurity guidance on medical devices, manufacturers should follow "secure by design" principles, ensure cyber transparency, conduct threat modeling, and ...

The US Food and Drug Administration (FDA) announced its intent on Thursday to exempt certain unclassified medical devices ...

After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...

As FDA medical device lawyers advising AI and digital health companies, Hogan Lovells lawyers have had a front-row seat to an increasingly common scenario: software platforms and mobile apps that ...

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 ...

Katie covers the impact of health technology on patients, clinicians, and businesses. Her stories explore the price tag of clinical AI, digital health at the FDA, and the boom in direct-to-consumer ...

June 3 (Reuters) - The U.S. FDA issued a warning letter to medical device maker Medline over violations of manufacturing ...

FDA revises 2022 human factors guidance with new risk-based categories, device modification examples, and 60-day ...