Medical Devices and Pharma
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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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Latest Posts
FDA QMSR: Overview of the ISO 13485 Standard
Starting on February 2, 2026, most medical device companies who sell their devices in the United States must comply with FDA’s new Quality Management System Regulation (QMSR, 21 CFR 820), which on that day will replace the current Quality System Regulation (QSR, 21...
QMSR Frequently Asked Questions
Although the FDA has done an excellent job of laying out QMSR requirements and explaining differences between the QSR and the QMSR, there are questions related to the implementation of the new Quality Management System Regulation (QMSR) that need an answer. This page...
EU MDR Compliance Consulting Services
Medical Devices and Pharma offers comprehensive services to help your business meet the stringent requirements of the EU Medical Device Regulation (MDR). Our expertise ensures that your products are compliant, safe, and ready for the European market.At Medical Devices...
Extensions for EU MDR and IVDR Implementation
Initial EU MDR and IVDR transition periods extended In 2023, the European Union granted an extension for the implementation of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR) due to various challenges faced by...
Implementation of the EU MDR and IVDR
A Significant EU Regulatory System Overhaul The implementation of the European Union's Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) represents a significant overhaul of the regulatory framework governing medical devices and...
FDA Grants Accelerated Approval to Tarlatamab-dlle
Treatment for lung cancer with progression following platinum-based chemotherapy On May 16, 2024, the Food and Drug Administration (FDA) granted accelerated approval to Imdelltra (tarlatamab-dlle) manufactured by Amgen, Inc. for the treatment of extensive stage small...
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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.
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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