by Bruce Waldon | Mar 15, 2026 | Consumer Information, Consumer Safety, Dietary Supplements, Editorial, FDA Safety Communication, Industry Information, Labeling, Safety, Unapproved Drugs, US-FDA
Honey-Based Dietary Supplements Recalled Sildenafil and tadalafil not declared on product labeling Home About Consumer Food and Beverage Supplements Regulatory Medical Devices Pharma Biologics Combination Products Veterinary AI Quality QMSR Central News Enforcement...
by Bruce Waldon | Dec 13, 2025 | Consumer Information, Consumer Safety, Dietary Supplements, DSHEA, Industry Information, Industry News, Legislation, Product Quality, Product Recalls, Quality Information, Reg_Science, Regulatory_Info, Safety
Supplement Industry Self-Regulation Mixed results related to manufacturer prominence Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Has Industry Self-Regulation...
by Bruce Waldon | Dec 11, 2025 | Alerts, Alerts-Supplements, Consumer Information, Dietary Supplements, DSHEA, Industry Information, Industry News, Legislation, MedWatch-System, Product Quality, Quality Information, Safety
The 30-Year Consequences of DSHEA A direct cause of the supplement safety crisis Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact How a 1994 Law Created Today’s...
by Bruce Waldon | Nov 6, 2025 | Design and Development, Design Changes, FDA Regulations, Human Factors, Industry News, International standards, ISO 13485, ISO 14971, Med-Devices, Product Design, Product Quality, QMSR, Safety, US-FDA
When a “Good Enough” Design May Fail the User A Case Study in Usability Home Request Info QMSR Central QMSR FAQs ISO 13485 Transition Impact Integration Definitions FDA and ISO 13485 ISO 9000 Small Manufacturers Advancing from Basic Design to Usability In a world...
by MDP Staff | Jul 25, 2025 | Alerts, Alerts-Device, Class I Recalls, FDA Safety Communication, Industry News, Med-Devices, Product Recalls, Product Safety, Safety, Surgical
Ethicon Issues Safety Alert for Endopath Echelon Vascular Reload Surgical Stapler Cartridge Correction Home About Consumer Medical Devices Pharma Biologics Biologics Warning Letters AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Endopath...
by MDP Staff | Jul 24, 2025 | FDA Reports, Industry Information, MDR - Medical Device Report, Quality system, Safety, US-FDA
FDA Medical Device Reporting Know when and how to file an MDR Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact U.S. FDA Medical Device Reporting What is 21 CFR Part 803 (Medical Device...