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...
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...
When Apparel Becomes a Medical Device
Lessons from FDA’s Breast Binder Warning Letters In December 2025, the FDA issued warning letters to several companies selling breast binders and chest compression garments online. The agency concluded that marketing claims on company websites, like statements about...
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...
FDA Program to Accelerate U.S. Pharmaceutical Manufacturing
FDA Launches “PreCheck” Pilot Program to Accelerate U.S. Pharmaceutical Manufacturing The U.S. Food and Drug Administration has launched a new pilot initiative aimed at strengthening domestic pharmaceutical manufacturing and improving regulatory predictability for...
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...
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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 Early Alert for Baxter Pressure Breathing Device
FDA Issues Early Alert for Baxter Volara System Patient Circuits Following Therapy Leakage Concerns The U.S. Food and Drug...
FDA Early Alert – Hamilton Medical Breathing Circuit Sets
FDA Issues Early Alert for Hamilton Medical Breathing Circuit Sets Following Reports of Serious Injuries The U.S. Food and...
FDA Early Alert for GE HealthCare Infant Resuscitation Systems
FDA Issues Early Alert for GE HealthCare Infant Resuscitation Systems Due to Oxygen Blender Issue Early Alert for GE...
Gas Station Drugs: The Regulatory Wild West
Walk into enough gas stations, smoke shops or convenience stores in America and eventually you will encounter a strange...
Warning Letter Cites Serious Deficiencies at Pharma Facility
Serious Sterility and CGMP Deficiencies at ProRx Outsourcing Facility The FDA has issued a significant Warning Letter to...
FDA-Approved Vivistim: A New Pathway in Stroke Recovery
Vivistim implantable vagus nerve stimulator. Source: Vivistim.com.FDA-Approved Vagus Nerve Stimulation Device Opens a New...
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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