Medical Devices and Pharma
Medical device and pharmaceutical regulatory consulting and health safety informationWelcome 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.
- Regulatory services for compliance, market access, and crisis management
- Information about innovation, including new products cleared for use in the U.S. market.
- News stories with topics ranging from product issues to market trends.
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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The Latest Posts
CPAP Machines
What Is a CPAP Machine? A CPAP (Continuous Positive Airway Pressure) machine is a medical device used primarily to treat sleep apnea, a condition characterized by pauses in breathing or shallow breaths during sleep. CPAP therapy involves delivering a continuous...
FDA Approves Versatile Antibiotic Zevtera for Three Key Infections
FDA Approves Versatile Antibiotic Zevtera for Three Key Infections The U.S. Food and Drug Administration (FDA) announced today that the fight against bacterial infections has gained a significant boost with the recent approval of Zevtera (ceftobiprole medocaril...
Urgent Recall Notice for ARROW QuickFlash Catheterization Kits
Urgent Recall Notice for ARROW QuickFlash Catheterization Kits In February 2024, Teleflex and its subsidiary Arrow International issued an urgent recall notice for the ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits. Today, a...
Plastic Syringe Safety: FDA’s Ongoing Evaluation
Today, the U.S. Food and Drug Administration (FDA) provided a crucial update regarding the quality and performance issues associated with plastic syringes made in China. This announcement follows the agency's previous safety communication issued on November 30, 2023,...
Original FDA Safety Warning for China-made Syringes
In an announcement dated November 30, 2023, the U.S. Food and Drug Administration (FDA) issued a notice regarding the evaluation of potential device failures associated with plastic syringes manufactured in China. The FDA is actively collecting and analyzing data to...
AvKARE Recalls Atovaquone Oral Suspension
AvKARE Recalls Atovaquone Oral Suspension AvKARE, LLC has issued a voluntary recall of lot # AW0221A of Atovaquone Oral Suspension, USP 750mg/5mL due to potential Bacillus cereus contamination found during stability testing at a third-party lab. The affected...