The FDA issued Zoll Medical a warning letter outlining quality system regulation violations and violations of medical device ...

FDA issued a warning letter to Zoll Medical following a 14-month inspection of its Chelmsford, Massachusetts facility.

FDA plans to limit the regulation of wearable medical devices, according to a January 6 notice from the agency. Currently, the majority of fitness tracking wearables and fitness apps are classified as ...

CHELMSFORD — Medical device manufacturer Zoll was given a warning letter by the U.S. Food and Drug Administration for what the FDA said were violations of quality systems and medical device reporting ...

The new initiative is intended to improve the global oversight of medical devices, AI, and innovative medicines and to ...

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

Last month I outlined the triggers that could cause an ordinary mobile phone to become an FDA-regulated medical mobile phone. This month, in the second of six planned articles, I will outline the FDA ...

US Food and Drug Administration (FDA) Commissioner Margaret Hamburg recently announced that her agency would soon end a long-standing policy of enforcement discretion toward a classification of ...

The Food and Drug Administration (FDA) regulates medications, medical devices, foods, cosmetics, certain electronic devices, pet and livestock products, and tobacco products. FDA regulation involves ...

In the United States, medical device regulation and intellectual property (IP) protection are governed by complex statutory and regulatory frameworks that are distinct from—but closely related to, and ...