Medical Devices and Pharma
Medical device and pharmaceutical regulatory consulting and health safety informationHeadlines
Risks with Exactech Equinoxe Shoulder System
FDA Safety Communication April 19 Update: Exactech has initiated a recall to remove Equinoxe Shoulder System devices packaged in the defective bags from facilities’ unused inventory. To see if your device is affected by the recall, visit Exactech’s Recall...
Important Recall Notice for BioMérieux VITEK 2 AST Kit
Class I Recall Notice BioMérieux Inc. has issued a crucial recall notice for its VITEK 2 AST kit, a vital tool in determining bacterial susceptibility to antibiotics. The Food and Drug Administration (FDA) classifies this recall as Class I, indicating a severe risk...
SonarMed Inc Recalls Airway Acoustic Sensors
Urgent Class I Recall Notice SonarMed Inc. has issued a Class I recall for its Airway acoustic sensors due to a critical issue that could lead to serious health consequences for patients. The U.S. Food and Drug Administration (FDA) has identified this as the most...
DeRoyal Industries, Inc. Recalls Tracecarts
Urgent Class I Recall Notice DeRoyal Industries, Inc. has issued an urgent recall notice for certain Tracecarts containing 16FR Urine Meter Foley under recall by Nurse Assist. Identified by the FDA as a Class I recall, the most serious type, the use of these devices...
QSR-to-QMSR Paper Gap Audit
Is Your Quality Management System Ready for QMSR? As FDA’s transition from the QSR to the QMSR approaches, many medical device manufacturers are discovering that “substantially equivalent” doesn’t mean “completely aligned.” Even companies with solid QSR documentation...
Postmarket Surveillance – from QSR to QMSR
How QSR Postmarket Surveillance Will Evolve Under the QMSR As medical device manufacturers transition from the FDA’s Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR), one area undergoing significant change is postmarket...
Medical Device Labeling
In the world of medical devices, proper labeling isn't just a regulatory requirement, it is a vital component of patient safety, product usability, and market access. Whether you're a manufacturer navigating FDA regulations, a distributor handling multilingual...
QMSR Clause 8 – Measurement Analysis and Improvement
ISO 13485 Clause 8 Transition Notes The QMSR eliminates FDA-specific structure in favor of ISO 13485:2016 clauses. All above ISO 13485 clauses are now explicit requirements under QMSR. New documentation and risk-based decision-making are emphasized throughout the...
FDA Issues Warning on Counterfeit Botox Products
Real Botox PackagingReal Botox Cosmetic PackagingReal Botox PackagingCounterfeit Botox Products The U.S. Food and Drug Administration (FDA) has issued a critical alert concerning the presence of counterfeit Botox products in various states, posing severe risks to...
FDA Approves Xolremdi for WHIM Syndrome
A Breakthrough for Rare Infections In a groundbreaking development, the U.S. Food and Drug Administration (FDA) has granted approval for Xolremdi (mavorixafor) capsules, marking a significant milestone in the treatment of WHIM syndrome. Let's delve into what this...
FDA Fast Track Program
For Serious Conditions - Unmet Medical Needs The FDA's Fast Track program is designed to facilitate the development and expedite the review of drugs and biologics intended to treat serious conditions and fill an unmet medical need. Following are key details of the...
FDA’s Orphan Drug Program
Expedite Development of New Orphan Drugs The FDA's Orphan Drug Program is designed to encourage the development of drugs and biologics for the treatment, diagnosis, or prevention of rare diseases or conditions, often referred to as orphan diseases. Here are the key...
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Organic Moringa Powder Recalled for Salmonella Contamination
On November 12, organic moringa powder importer and packager Africa Imports issued a recall notice for its products dating back to June 5. The recall notice was published on the FDA website. Following are details of the recall. Who Issued the Recall Africa Imports...
FDA Cracks Down on Illegally Marketed 7-OH Products
Unapproved drugs sold online and in retail locations Yesterday the U.S. Food and Drug Administration (FDA) issued seven warning letters to companies marketing products that contain 7-hydroxymitragynine (7-OH) — a powerful and potentially dangerous opioid-like...
The FDA Orphan Drug Program
Incentives for Rare Disease Drug Development The FDA’s Orphan Drug Program was established to encourage the development of drugs for rare diseases that affect fewer than 200,000 people in the U.S. Because these diseases often lack market incentives due to small...
A Dangerous and Unapproved Drug Sold as a “Cure”
The dangers of tianeptine FDA warns that tianeptine is sold online and even at gas stations as a supposed treatment for depression, anxiety, pain, and opioid withdrawal. But don’t be fooled — this drug is not approved by the FDA for any medical use in the U.S. and has...
Latest Posts
FDA Completes Risk Review of Canine Freeze-Dried Plasma
Freeze-Dried Plasma for Emergency Use in Dogs The U.S. Food and Drug Administration (FDA) has completed a risk review of Mantel’s Canine Freeze-Dried Plasma (cFDP), a pooled allogeneic canine plasma product intended for the treatment of hypovolemia and control of...
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...
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...
How U.S. Testosterone Regulation Reached a Crossroads
How U.S. Testosterone Regulation Reached a Crossroads The FDA’s approach to testosterone therapy has undergone one of the most unusual and dramatic evolutions in modern drug regulation. What began as a cautious, evidence-driven posture in 2014 has, by late 2025,...
Canine microRNA Biomarkers and Osteosarcoma Diagnostics
The Diagnostic Problem Despite advances in surgery and chemotherapy, survival outcomes for osteosarcoma have changed little in more than 30 years – largely because metastasis is detected too late. Current diagnostics rely on imaging (often after spread has occurred),...
Canine Osteosarcoma Immunotherapy and Human Research
Osteosarcoma Osteosarcoma is a devastating bone cancer with limited treatment progress over decades. In humans, it remains rare but deadly – striking roughly 1,000 Americans each year, often children and adolescents. It is tragically common in dogs, with an estimated...
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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.
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