Medical Devices and Pharma
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The IMDRF: International Regulators
The International Medical Device Regulators Forum (IMDRF) plays a pivotal role in shaping global regulatory approaches and...
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,...
DeRoyal Industries, Inc. Recalls Tracecarts
Urgent Class I Recall Notice DeRoyal Industries, Inc. has issued an urgent recall notice for certain Tracecarts...
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...
Regulatory Information Management Systems (RIMS)
What Is a RIMS System? A Regulatory Information Management (RIM) system is a software solution designed to streamline 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...
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.
Medical Devices
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