The Abbott NEC Case and Food Risk in Vulnerable Populations

by | Apr 13, 2026 | Food, Industry Information, Industry News, Labeling, Legal, Litigation, Products - Food, Reg_Information, Reg_Products, Reg_Science, Safety

Home About Consumer News Food and Beverage Supplements Cosmetics Regulatory Medical Devices Pharma Biologics Combination Products In Vitro Diagnostics Veterinary AI Quality QMSR Central News Enforcement Alerts Innovation Contact What the Abbott NEC Case Reveals About...

When a Small Process Failure Becomes a Patient Safety Event

by | Mar 23, 2026 | Analysis, Editorial, ISO 14971, Med-Devices, Product Design, Product Quality, Products_Devices, QMSR, Quality system, Reg_Information, Reg_Products, US-FDA

Medical Device Safety Alert Erbe cryoprobes may rupture or burst Home About Consumer Food and Beverage Supplements Regulatory Medical Devices Pharma Biologics Combination Products Veterinary AI Quality QMSR Central News Enforcement Alerts Innovation Contact What the...

When Apparel Becomes a Medical Device

by | Mar 4, 2026 | Analysis, Device Warning Letters, FDA Enforcement, Industry Information, Industry News, Labeling, Med-Devices, Medical Device Labeling, Reg_Information, Regulatory_Info, US-FDA

MDP Regulatory Insight When apparel becomes a medical device Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products Veterinary AI Quality QMSR Central News Enforcement Alerts Innovation Contact Lessons from FDA’s Breast Binder Warning...

Testosterone Regulation Takes a Sharp Turn

by | Dec 18, 2025 | Alerts-Pharma, Analysis, Consumer Information, Consumer Safety, Editorial, FDA Policy, FDA Regulations, Hormones, Industry Information, Industry News, Product Safety, Products_Drugs, Regulatory_Info

Testosterone Regulation Takes a Sharp Turn Why FDA’s December panel raises red flags Home Request Info QMSR Central QMSR FAQs ISO 13485 Transition Impact Integration Definitions FDA and ISO 13485 ISO 9000 Small Manufacturers Why FDA’s December Panel Raises Red Flags...

Invisible Outbreak of Contaminated Supplement Ingredients

by | Dec 11, 2025 | Alerts, Alerts-Supplements, Consumer Information, Consumer Safety, Dietary Supplements, DSHEA, Editorial, FDA Regulations, FDA_Legislation, Industry Information, Industry News, Legislation, Product Quality, Product Recalls, Quality Information, Reg_Information, Reg_Products, Regulatory_Info, US-FDA

The Invisible Outbreak An untraced distribution of salmonella-contaminated products Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Contaminated Products...