Class I Correction for Homecare Bed Fire and Entrapment Risks

by Bruce Waldon | Apr 6, 2026 | Alerts, Alerts-Device, Consumer Information, DME, Med-Devices, MedWatch-System, Product Corrections, Safety, US-FDA

FDA Class I Recall Medline homecare beds Home About Consumer News Food and Beverage Supplements Regulatory Medical Devices Pharma Biologics Combination Products Veterinary AI Quality QMSR Central News Enforcement Alerts Innovation Contact Medline Homecare Beds: FDA...

Nivolumab Combination Therapy for Advanced Hodgkin Lymphoma

by Bruce Waldon | Mar 24, 2026 | FDA Approvals, FDA_Innovation, Industry Information, Industry News, New Drugs, Product-Innovation, Products_Drugs, Reg_Products, US-FDA

FDA Regulatory Innovation Nivolumab Combination Therapy Home About Consumer Food and Beverage Supplements Regulatory Medical Devices Pharma Biologics Combination Products Veterinary AI Quality QMSR Central News Enforcement Alerts Innovation Contact FDA Approves...

When a Small Process Failure Becomes a Patient Safety Event

by Bruce Waldon | 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...

FDA Flags High-Risk Issue with Erbe Flexible Cryoprobes

by Bruce Waldon | Mar 23, 2026 | Alerts, Alerts-Device, Industry Information, Industry News, Med-Devices, MedWatch-System, Product Safety, Safety, 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 FDA Flags...

EPA Proposes Rollback of EtO Sterilization Emissions Limits

by Bruce Waldon | Mar 19, 2026 | EtO, Industry Information, Industry News, Med-Devices, Products_Devices, Sterilization, US-FDA

EtO Regulation Rollback EPA seeks to weaken emissions restrictions Home About Consumer Food and Beverage Supplements Regulatory Medical Devices Pharma Biologics Combination Products Veterinary AI Quality QMSR Central News Enforcement Alerts Innovation Contact EPA...

Adulterated Supplements and the Limits of Post-Market Oversight

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...