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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Exposure to toxic materials during hemodialysis and dialysis
FDA announcement The US Food and Drug Administration (FDA) issued an announcement on March 7 to update its May 2022 letter to healthcare providers regarding the potential risks of exposure to toxic compounds when using hemodialysis and peritoneal dialysis. This update...
FDA Breakthrough Devices Program
FDA Breakthrough Devices Program The U.S. Food and Drug Administration (FDA) has established the Breakthrough Devices Program, a voluntary program that aims to expedite the development, assessment, and review of medical devices that demonstrate potential to provide...
Approvals for FDA Breakthrough Devices
Innovative Devices for Unmet Needs The Food and Drug Administration (FDA) has made a positive decision on the marketing applications of the following products. What sets them apart? They are innovative devices that qualified and participated in FDA's Breakthough...
FDA Explores Dental Device Safety Concerns
Dental Devices to Treat Sleep Apnea and TMD The FDA is currently evaluating safety concerns related to certain dental devices called fixed (non-removable) palatal expanders, which are used on adults for jaw remodeling or to treat conditions like obstructive sleep...
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FDA Alert: Baxter Recalls Spectrum Infusion Pumps
Baxter Spectrum Infusion Pump Alert Date: July 2025Device: Sigma Spectrum Infusion System (V6 and V8...
Human Factors Engineering
Human Factors Engineering Human Factors Engineering (HFE) is critical for medical device safety and regulatory compliance,...
Orthopedics Industry Consolidation
Consolidation in the Implantable Orthopedics Industry: A Historical Perspective Early Growth and Initial Consolidation...
How Unsafe Medical Devices Can Slip Through the Cracks
Healthcare professionals and the device industry share responsibility for timely adverse event reportingGlobal device...
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...
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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