Medical Devices and Pharma
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FDA Quality System Regulation – 21 CFR 820
QMSR CentralFDA Quality System Regulation – 21 CFR 820 21 CFR 820, also known as the Quality System Regulation (QSR), outlines the requirements for the establishment and maintenance of a quality management system for medical device manufacturers in the United States....
Edwards EVOQUE Tricuspid Valve Replacement System
Edwards EVOQUE Tricuspid Valve Replacement System In a groundbreaking move, the FDA has recently approved the Edwards EVOQUE Tricuspid Valve Replacement System for market distribution. The device was developed by Edwards Lifesciences LLC. This innovative system...
Device Overview – Spinal Cord Stimulation Systems
What Is an SCS System? A spinal cord stimulation (SCS) system is a medical device used to manage chronic pain by delivering electrical impulses to the spinal cord. The system typically consists of several components: Implantable Pulse Generator (IPG) This is the...
Prospera Spinal Cord Stimulation System for Intractable Back Pain
Prospera Spinal Cord Stimulation System FDA has recently approved the Prospera Spinal Cord Stimulation (SCS) System, developed by BIOTRONIK NRO, INC., as a treatment for chronic, difficult-to-manage pain in the trunk or limbs. This implanted system comprises a...
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Camber Recalls Atovaquone Oral Suspension USP
Camber Recalls Atovaquone Oral Suspension USP for Potential Contamination Camber Pharmaceuticals Inc. recently issued a voluntary nationwide recall of Atovaquone Oral Suspension USP due to potential contamination. The recall was announced by the U.S. Food and Drug...
Prodigy Proclaim Spinal Cord Stimulation Systems
Significant advancement for chronic pain treatment On February 15, 2023, the U.S. Food and Drug Administration (FDA) announced the approval of the Prodigy Proclaim and Proclaim XR Spinal Cord Stimulation (SCS) systems. This approval marks a significant step forward in...
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...
Mechanical Circulatory Support (MCS) Devices
Overview of MCS Devices Mechanical Circulatory Support (MCS) devices have transformed the landscape of advanced heart...
Recall Alert: AirLife/Vyaire Infant Breathing Systems
Class I Recall AirLife and manufacturer Vyaire are recalling specific Infant Heated Wire Circuits due to the risk that...
Avanos Recalls Ballard Closed Suction Systems
May result in non-sterile devices Avanos Medical, Inc. is recalling its Ballard Closed Suction Systems after identifying a...
The FDA Orphan Drug Program
Incentives for Rare Disease Drug Development The FDA’s Orphan Drug Program was established to encourage the development of...
FDA Grants Accelerated Approval to Multiple Myeloma Treatment
For hard-to-treat multiple myeloma On July 2, 2025, the FDA granted accelerated approval to linvoseltamab-gcpt (brand name:...
FDA Approves Alhemo for Patients with Hemophilia A or B
For Patients with Hemophilia A or B with Inhibitors The FDA has approved Alhemo (concizumab-mtci) for routine prophylaxis...
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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