Medical Devices and Pharma
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Class I Recall for Stay-Safe Catheter Extension Sets and Adapters
Urgent Class I Recall Notice FDA has issued a Class I recall – the most serious type – for certain medical devices manufactured by Fresenius Medical Care. The recall concerns Stay-Safe Catheter Extension Sets and Stay-Safe/Luer Lock Adapters, pivotal components used...
Regulatory Information Management Systems (RIMS)
What Is a RIMS System? A Regulatory Information Management (RIM) system is a software solution designed to streamline and automate the management of regulatory information and processes within the life sciences industry, including pharmaceuticals, biotechnology, and...
Abbott/Thoratec Recalls HeartMate II and HeartMate 3 LVAS
Recall Alert: HeartMate II and HeartMate 3 Left Ventricular Assist Systems (LVAS) The FDA has issued a Class I recall, the most serious type, for the HeartMate II and HeartMate 3 Left Ventricular Assist Systems (LVAS) due to potential serious injuries or death...
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...
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Amneal Recalls Vancomycin Hydrochloride Oral Solution
Some bottles may be super potent Attention Patients, Health Professionals, and Pharmacies: Amneal Pharmaceuticals issued a safety notice on March 27 for a recall of specific lots of Vancomycin Hydrochloride for Oral Solution USP, 250 mg/ 5mL. This recall has been...
FDA Proposes Ban of Certain ESDs
Ban would affect devices used to treat aggressive/self-injurious behavior In a landmark move, the U.S. Food and Drug Administration (FDA) has proposed a ban on electrical stimulation devices (ESDs) designed to reduce or stop self-injurious or aggressive behavior. This...
FDA Approves Thoracic Stent Graft System
FDA Approves RelayPro Thoracic Stent Graft System for Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers Treatment The United States Food and Drug Administration (FDA) on March 7, 2023 approved the RelayPro Thoracic Stent Graft System, a new medical...
Abbott Safety Alert for Freestyle Libre Systems
Misuse may cause battery overheating and incorrect readings The FDA has issued a safety notification regarding the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash Glucose Monitoring Systems. The notification warns users of the potential for...
FDA Cracks Down on Insightra Medical
Warning Letter Cites a Number of Serious Violations In a scathing warning letter, the FDA has cited Insightra Medical, Inc....
FDA Cracks Down on Illegally Marketed 7-OH Products
Unapproved drugs sold online and in retail locations Yesterday the U.S. Food and Drug Administration (FDA) issued seven...
Sterile Drug Manufacturing Violations at Daewoo Pharmaceutical
FDA Cracks Down on Sterile Drug Manufacturing Violations The U.S. Food and Drug Administration (FDA) has issued a warning...
What Are Early Recall Alerts?
Recall Communication “Early Alerts” Note: This summary is based on an FDA communication attributed to Michelle Tarver,...
Urgent Recall Alert for BD Alaris Infusion Sets
Class I Recall (Correction) The FDA has issued an early alert to healthcare providers and patients regarding a performance...
Cosmetic Products
FDA Regulation of Cosmetic Products Cosmetics are a part of daily life for millions of people—but what many consumers and...
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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