On October 3, the U.S. Food & Drug Administration (FDA) published a highly anticipated proposed rule (Proposed Rule) to regulate laboratory-developed tests (LDTs) as medical devices. LDTs are ...

Key Takeaways: The Food and Drug Administration (FDA) issued a Final Rule to amend device current good manufacturing practices (CGMP) requirements of the Quality System (QS) regulation to ...

SBOMs And The Future Of Medical Device Cybersecurity Compliance and regulations can support product development in a positive way. The FDA mandate fits in this category.

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...

Go-To Guide: On Feb. 2, 2024, the U.S. Food and Drug Administration (FDA) published a final rule amending, for the first time since 1996, medical device current good manufacturing (cGMP ...

The FDA stands as a robust guardian of patient safety and quality standards within the medical device industry. Through stringent regulatory processes, it ensures that only safe and effective ...

This same concept is uniquely suited to the regulation of artificial intelligence (AI) medical devices that can augment patient care. Legislation currently before Congress (Senate Bill 2209 and ...

Medical devices that receive necessary clearance or approval from the FDA can be marketed for sale and use in the United States. 3 What are the basic regulatory requirements for medical device ...

Proposals include establishing "indirect recognition" of EU CE-marked devices to the UK market and "international reliance" ...