Medical Devices and Pharma
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Overview of ISO 13485
ISO 13485, Medical devices quality management systems ISO 13485, Medical devices quality management systems, is an international standard that specifies requirements for a quality management system (QMS) for medical device manufacturers. It also outlines requirements...
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...
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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...
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...
Update – Carcinoma Inside Capsule of Breast Implants
Squamous Cell Carcinoma and Various Lymphomas Located in the Capsule around Breast Implants On March 22, the US Food and Drug Administration (FDA) issued an update to its March 8 safety communication regarding reports of squamous cell carcinoma (SCC) and lymphomas in...
Carcinoma and Lymphomas Found Near Breast Implants
Squamous Cell Carcinoma and Various Lymphomas Located in the Capsule around Breast Implants On March 8, the US Food and Drug Administration (FDA) issued a safety communication concerning reports of squamous cell carcinoma (SCC) and various types of lymphomas in the...
How U.S. Testosterone Regulation Reached a Crossroads
How U.S. Testosterone Regulation Reached a Crossroads The FDA’s approach to testosterone therapy has undergone one of the...
Canine microRNA Biomarkers and Osteosarcoma Diagnostics
The Diagnostic Problem Despite advances in surgery and chemotherapy, survival outcomes for osteosarcoma have changed little...
Canine Osteosarcoma Immunotherapy and Human Research
Osteosarcoma Osteosarcoma is a devastating bone cancer with limited treatment progress over decades. In humans, it remains...
Do Not Blame FDA for Lax Oversight of Dietary Supplements
A Regulatory System Designed to Fail The recent recalls involving contaminated moringa leaf powder should alarm every...
Has Industry Self-Regulation Been Effective?
Has Industry Self-Regulation Been Effective? Supplement industry self-regulation has helped in limited ways, but it has...
Why DSHEA Reform Must Be a Priority
Why DSHEA Reform Must Be a Priority The recent wave of moringa-related contamination recalls – touching national retail...
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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