Medical Device and Pharmaceutical News
The latest information of interest to regulated industry. Bookmark this page to have a quick review for
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Important Recall Notice for BioMérieux VITEK 2 AST Kit
Class I Recall Notice BioMérieux Inc. has issued a crucial recall notice for its VITEK 2 AST kit, a vital tool in determining bacterial susceptibility to antibiotics. The Food and Drug Administration (FDA) classifies this recall as Class I, indicating a severe risk...
ICH: The International Council for Harmonization
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) plays a pivotal role in shaping global pharmaceutical practices, ensuring the quality, safety, and efficacy of medicines worldwide.The International Council...
SonarMed Inc Recalls Airway Acoustic Sensors
Urgent Class I Recall Notice SonarMed Inc. has issued a Class I recall for its Airway acoustic sensors due to a critical issue that could lead to serious health consequences for patients. The U.S. Food and Drug Administration (FDA) has identified this as the most...
FDA Submission and Approval Processes for 510(k)s
Learn how the FDA's 510(k) premarket notification system facilitates the introduction of new medical devices to the market, ensuring safety and compliance.Partner with us to navigate the complexities of the FDA approval process efficiently.The FDA's 510(k) process is...
DeRoyal Industries, Inc. Recalls Tracecarts
Urgent Class I Recall Notice DeRoyal Industries, Inc. has issued an urgent recall notice for certain Tracecarts containing 16FR Urine Meter Foley under recall by Nurse Assist. Identified by the FDA as a Class I recall, the most serious type, the use of these devices...
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...
FDA Enforcement
The Food and Drug Administration (FDA) in the United States employs various enforcement mechanisms to ensure compliance with regulatory requirements and to protect public health. These mechanisms are essential for maintaining the safety, efficacy, and quality of food,...
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....