Medical Device and Pharmaceutical News
The latest information of interest to regulated industry. Bookmark this page to have a quick review for
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Has Industry Self-Regulation Been Effective?
Has Industry Self-Regulation Been Effective? Supplement industry self-regulation has helped in limited ways, but it has not been sufficient to ensure reliable safety. What has worked Voluntary GMP certifications (e.g., NSF, USP, Informed Choice) A minority of...
Why DSHEA Reform Must Be a Priority
Why DSHEA Reform Must Be a Priority The recent wave of moringa-related contamination recalls – touching national retail chains and rippling through dozens of contract manufacturers – has forced an uncomfortable question into public view: How was a single tainted...
The 30-Year Consequences of Faulty Supplement Legislation
How a 1994 Law Created Today’s Dietary Supplement Crisis In light of the current moringa contamination recalls affecting national retailers and dozens of downstream manufacturers, many consumers are asking the same question: How did this happen? The answer leads us...
Invisible Outbreak of Contaminated Supplement Ingredients
Contaminated Products Distributed Nationwide How a contaminated Moringa shipment was spread across the U.S. supplement market, and why there were no additional recalls. Sam’s Club announced a recall of its Member’s Mark Super Greens powder in late October 2025 due...
Organic Moringa Powder Recalled for Salmonella Contamination
On November 12, organic moringa powder importer and packager Africa Imports issued a recall notice for its products dating back to June 5. The recall notice was published on the FDA website. Following are details of the recall. Who Issued the Recall Africa Imports...
When a “Good Enough” Design May Fail the User
Advancing from Basic Design to Usability In a world shifting toward user-centered regulation, even the simplest medical devices can demonstrate why human factors and usability engineering matter. The FDA’s Quality Management System Regulation (QMSR) – which aligns...
FDA “PreCheck” Program to Boost U.S. Drug Manufacturing
FDA Announces New PreCheck Drug Manufacturing Program The U.S. Food and Drug Administration (FDA) has announced the launch of FDA PreCheck, a groundbreaking new program designed to strengthen America’s domestic pharmaceutical supply chain by streamlining the...
Ethicon Issues Safety Alert for Surgical Stapler Cartridge
Endopath Echelon Vascular White Reload for Advanced Placement TipSource: FDAUrgent Class I Medical Device Recall Ethicon Endo-Surgery, LLC has issued an urgent correction for its Endopath Echelon Vascular White Reload for Advanced Placement Tip (35 mm, 4-row). This...
Global Medical Device Reporting and Vigilance
International Medical Device Reporting Medical Device Reporting and Vigilance in the EU and Globally Timely and transparent reporting of medical device incidents is critical to protecting public health and ensuring continued confidence in healthcare technologies....
U.S. Medical Device Reporting
U.S. FDA Medical Device Reporting What is 21 CFR Part 803 (Medical Device Reporting)? This regulation establishes mandatory postmarket surveillance requirements to ensure that the FDA is informed of deaths, serious injuries, and device malfunctions that could...