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...
Class I Correction for Abiomed Impella Inaccurate Flow Readings
Abiomed Impella RP: FDA Class I Correction for Inaccurate Flow Readings Abiomed has issued an Urgent Medical Device Correction for its Impella RP with SmartAssist and Impella RP Flex with SmartAssist systems due to potential inaccuracies in displayed pump performance...
Class I Correction for Homecare Bed Fire and Entrapment Risks
Medline Homecare Beds: FDA Class I Correction for Fire and Entrapment Risks Medline Industries has issued a critical safety correction involving multiple models of homecare beds following reports of overheating components, electrical hazards, and patient entrapment...
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...
FDA Issues 30 Warning Letters to Telehealth Firms
FDA Issues 30 Warning Letters to Telehealth Firms Over Compounded GLP-1 Marketing Claims On March 3, 2026, the U.S. Food and Drug Administration (FDA) announced that it has issued 30 warning letters to telehealth companies for making false or misleading claims...
FDA Warning Letter Cites Key CGMP and Data Integrity Failures
FDA Warning Letter Highlights Fundamental CGMP and Data Integrity Failures The FDA has issued a Warning Letter to A. Nelson & Co. Ltd. citing significant violations of Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Parts 210 and 211 at a...
FDA Approves First Generic Fenbendazole Oral Suspension
Defendazole™ (fenbendazole) 10% Oral Suspension The U.S. Food and Drug Administration has approved Defendazole™ (fenbendazole) 10% oral suspension, the first FDA-approved generic fenbendazole dewormer for use in beef and dairy cattle and goats. Defendazole is...
FDA Testosterone Panel Sparks Concern
Concerns Over Sudden Regulatory Shift The FDA’s December 2025 expert panel has recommended sweeping changes to testosterone regulation – a sharp departure from the agency’s long-standing cautionary stance for the hormone. The panel urged the FDA to broaden...
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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...
FDA Approves First Gene Therapy for Genetic Hearing Loss
FDA Approves First Gene Therapy for Genetic Hearing LossRapid Review and Breakthrough Science Converge in Landmark OTOF...
April 2026 Update for FDA QMSR Inspection Results
April 2026 Update for FDA QMSR Inspection ResultsConfirming the Shift to System-Level, Risk-Based Inspection When FDA’s...
Major Eye Drop Recall Shows Manufacturing and Inspection Issues
Kian Pee Wan Capsules Recalled for Undeclared Drug Ingredients
Kian Pee Wan Capsules Recalled Due to Undeclared Drug Ingredients Aphreseller (Buy-herbal.com), an online seller based in...
Good Brain Tonic recalled by Liquid Blenz due to botulism risk
Good Brain Tonic Recall: Liquid Blenz Removes Beverage Due to Botulism Risk FDA Issues Nationwide Alert for “Memory and...
Allergy Alert: Silver Moon LP dba Loard’s Ice Cream
Loard’s Ice Cream Recalls Products Due to Undeclared Allergens and Missing Ingredient Labeling Silver Moon LP, doing...
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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- Information about innovation, including new products cleared for use in the U.S. market.
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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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