Medical Devices and Pharma
Medical device and pharmaceutical regulatory consulting and health safety informationFDA and global regulatory affairs, consumer health, and professional development
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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...
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...
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Study Reveals Delays in Medical Device Adverse Event Reporting
Healthcare professionals and the device industry share responsibility for timely adverse event reportingLapses defeat the...
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...
Postmarket Surveillance – from QSR to QMSR
How QSR Postmarket Surveillance Will Evolve Under the QMSR As medical device manufacturers transition from the FDA’s...
Postmarket Surveillance
What is Postmarket Surveillance (PMS)? Postmarket surveillance (PMS) refers to all activities carried out by manufacturers...
Medical Device Labeling
In the world of medical devices, proper labeling isn't just a regulatory requirement, it is a vital component of patient...
QMSR Clause 8 – Measurement Analysis and Improvement
Using Data to Drive Quality, Risk Control, and Continuous Improvement Clause 8 of ISO 13485:2016 defines how organizations...
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.
- 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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