Medical Devices and Pharma
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Labeling Correction for TRUE METRIX® Blood Glucose Meters
Labeling Correction for TRUE METRIX® Blood Glucose Meters Highlights the Critical Role of Clear Error Messaging Trividia Health, Inc. has initiated a labeling correction affecting all TRUE METRIX®, TRUE METRIX AIR®, TRUE METRIX GO®, and TRUE METRIX PRO® blood glucose...
Testosterone Regulation Takes a Sharp Turn
Why FDA’s December Panel Raises Red Flags Regulatory Analysis The FDA’s regulation of testosterone therapy has long been a model of cautious, evidence-based policymaking. For more than a decade, the agency maintained a consistent position: testosterone was approved...
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...
Device Recall Alert: Edwards Lifesciences Arterial Cannula
Edwards Lifesciences Arterial CannulaSource: FDAEdwards Lifesciences Recalls Arterial Cannulae Over Risk of Exposed Wire Edwards Lifesciences has issued a Class I recall of certain arterial cannula devices due to the risk of wire exposure near the cannula tip, which...
When a Small Process Failure Becomes a Patient Safety Event
What the Erbe Cryoprobe Alert Teaches Us About Modern Device Quality The FDA’s recent Early Alert regarding flexible cryoprobes manufactured by Erbe USA is a textbook example of a fundamental truth in medical device quality. That small manufacturing deviations can...
FDA Flags High-Risk Issue with Erbe Flexible Cryoprobes
FDA Flags High-Risk Issue with Erbe Flexible Cryoprobes The FDA’s Center for Devices and Radiological Health (CDRH) has issued an Early Alert regarding a potentially high-risk issue involving certain flexible cryoprobes manufactured by Erbe USA. Issue Overview Erbe...
EPA Proposes Rollback of EtO Sterilization Emissions Limits
EPA Proposes Rollback of Ethylene Oxide Sterilization Emissions LimitsThe U.S. Environmental Protection Agency has proposed weakening restrictions on emissions of ethylene oxide (EtO) from commercial sterilization facilities that sterilize medical devices. EtO plays a...
FDA Approves Novel Device for Pancreatic Cancer Treatment
FDA Approves Novel Device for Pancreatic Cancer Treatment The U.S. Food and Drug Administration has approved Optune Pax, a first-of-its-kind medical device designed to treat adult patients with locally advanced pancreatic cancer. Developed by Novocure, the portable...
Blaine Labs Recalls Wound Care Gels for Microbial Contamination
Blaine Labs, Inc Issues Voluntary Nationwide Recall of Wound Care Gel Products Due to Microbial Contamination Potential infection risk for vulnerable patients highlights critical quality system considerations Recall Overview Blaine Labs, Inc. has issued a voluntary...
Adulterated Supplements and the Limits of Post-Market Oversight
FDA Recall of Adulterated Supplements Raises Questions About DSHEA Oversight Lessons from the “Boner Bear” Recall The FDA’s recent recall of several honey-based “sexual enhancement” supplements illustrates a recurring problem in the dietary supplement marketplace:...
When Randomized Trials Are Not Possible
When Randomized Trials Are Not Possible: How Real-World Evidence Is Shaping FDA Drug Approvals The U.S. Food and Drug Administration’s recent approval of leucovorin (Wellcovorin) for cerebral folate transport deficiency caused by FOLR1 gene variants highlights an...
FDA Approves Cerebral Folate Transport Deficiency Treatment
FDA Approves First Treatment for Cerebral Folate Transport Deficiency The U.S. Food and Drug Administration (FDA) has approved an expanded use of Wellcovorin (leucovorin calcium) tablets to treat patients with cerebral folate deficiency caused by variants in the...
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Implications of the New Federal Vaccine Schedule for Children
The New Federal Vaccine Schedule for Children: What Changed and What Are the Implications?Authors: Jennifer Kates and Josh Michaud, KFF This story was originally published by KFF.As widely expected, and following a recent Presidential memorandum, the Department of...
When Generic Drugs Are Not Equivalent
Fighting for BreathLung transplant patient Hannah Goetz’s life depended on the generic version of a critical drug. It was supposed to be equivalent to the brand-name medication — but the FDA doesn’t always ensure that’s the case.by Megan Rose and Debbie Cenziper,...
Proposed Bill Would Increase Drug Labeling Transparency
Proposed Legislation would Require Generic Drug Labels to Bear Manufacturer, Location, and Key Suppliers ProPublica's RX Inspector tool provides manufacturer location and inspection information for 40k generic drug manufacturersby by Debbie Cenziper, ProPublica,...
FDA Removes Autism Treatments Warning
Chlorine Dioxide, Raw Camel Milk: The FDA No Longer Warns Against These and Other Ineffective Autism Treatments The FDA has taken down a webpage warning about therapies and products making “false claims” of treating autism. It’s part of a series of actions the agency...
Webcol Alcohol Prep Pads Recall Due to Microbial Contamination
Cardinal Health Recalls Alcohol Prep Pads Over Infection Risk Concerns Cardinal Health has issued a voluntary nationwide...
FDA Issues Warning Letter for Modifications to Infant Products
FDA Issues Warning Letter to Happiest Baby Over SNOO Smart Sleeper Modifications and Quality System Deficiencies The U.S....
FDA Expands Draeger Atlan Anesthesia Workstation Correction
More anesthesia machines added to correction for potential ventilation failure The U.S. Food and Drug Administration (FDA)...
Warning Letter to Zoll Medical for Major QMS Violations
Warning Letter to Zoll Medical for Major QMS Violations The U.S. Food and Drug Administration has issued a Warning Letter...
Abiomed Issues Correction for Automated Impella Controllers
Hardware Updates Required to Address Potential Loss of Hemodynamic Support Abiomed has issued a correction for certain...
Infant Formula Recalled after Reports of Botulism
Three Infants Hospitalized; Nationwide Recall Initiated Nara Organics has voluntarily recalled all lots of its powdered...
Welcome to Medical Devices and Pharma, a website dedicated to providing timely and relevant medical device and pharma information to the regulated medical device and pharmaceutical industries, and consumers of those products.
Our goal is to provide organized, clearly written information from regulatory affairs and consumer perspectives.
- Key information from the Food and Drug Administration (FDA), the federal regulatory agency responsible for providing oversight over the industries and assuring the safety and efficacy of their products.
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Perhaps most importantly, we will strive to maintain vigilance over product issues and their impacts. Check back here for consumer news, product alerts, and current litigation.
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