Medical Devices and Pharma
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FDA Issues Letter to Warn of Abbott Trifecta Valve Risks
Letter outlines risks associated with the heart valve On February 27, the FDA released a letter to healthcare providers concerning potential risks associated with Abbott Trifecta valves. The Trifecta valve is a type of heart valve that is implanted in patients during...
FDA Announces Recall of GE Nuclear Medicine Systems
1200-pound Devices Could Fall on Patients On February 15, the FDA issued a statement announcing a recall of certain nuclear medicine systems manufactured by GE Healthcare. The recall involves the 600/800 Series nuclear medicine systems, which are used to diagnose and...
FDA announces recall of LivaNova LifeSPARC System
The US Food and Drug Administration (FDA) has announced a recall of the Livanova TandemLife LifeSparc System, a medical device used for circulatory support during heart surgery. The recall was initiated due to the potential for the device to experience unintentional...
FDA Approves Sentimag Magnetic Localization System for Biopsies
Magtrace® and Sentimag® Magnetic Localization System Novel sentinel lymph node localization technique without radiation On December 6, 2022, the U.S. Food and Drug Administration (FDA) approved PMA P160053 Supplement S002 for the Magtrace and Sentimag Magnetic...
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QMSR Clauses 1 and 2 – Scope and Normative References
ISO 13485 Clause 1 and Clause 2 For medical device manufacturers, compliance with ISO 13485:2016 is essential to ensure the...
Generic Eliquis
Generic Eliquis Editor's note: FDA originally announced the approval of generic equivalents to Eliquis in 2019, and updated...
QMSR Design and Development Transfer and Changes
ISO 13485:2016 Design and Development Clause 7.3 - Design and DevelopmentClause 7.3.1 - GeneralClause 7.3.2 - Design and...
QMSR Design Verification and Validation
ISO 13485:2016 Design and Development Clause 7.3 - Design and DevelopmentClause 7.3.1 - GeneralClause 7.3.2 - Design and...
QMSR Design and Development Reviews
ISO 13485:2016 Clause 7.3 - Design and DevelopmentClause 7.3.1 - GeneralClause 7.3.2 - Design and development...
QMSR Design and Development – Design Inputs and Outputs
ISO 13485:2016 Design and Development Clause 7.3 - Design and DevelopmentClause 7.3.1 - GeneralClause 7.3.2 - Design 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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