Medical Devices and Pharma
Medical device and pharmaceutical regulatory consulting and health safety informationFDA and global regulatory affairs, consumer health, and professional development
Expert guidance for industry professionals and clear, reliable information for patients and consumers
Fresenius Kabi Recalls Ivenix Infusion Pump Software
Urgent Class I Recall Notice A crucial recall notice has been issued by Fresenius Kabi USA, LLC for the LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0, distributed between March 6, 2023, and March 20, 2024. The recall, initiated on March 7, 2024, is...
Urgent Recall for Boston Scientific Obsidio Conformable Embolic
Urgent Class I Recall Notice Boston Scientific Corporation issued a critical recall notice on February 20, 2024, for its Obsidio Conformable Embolic products. The recall affects products distributed between May 8, 2023, and February 8, 2024. Product Details ...
Medos International Recalls CEREBASE DA Guide Sheath
Urgent Class I Recall Notice Medos International Sàrl has issued an urgent recall for the Cerenovus CEREBASE DA Guide Sheath, a neurovascular catheter commonly used in procedures requiring precise navigation and access to blood vessels in the brain. The recall was...
Asensus Surgical Inc Issues Recall for Senhance Surgical System
Class I Recall Notice Asensus Surgical Inc. has announced a recall for its Senhance Surgical System due to malfunctions leading to unintended movement of the robotically-assisted surgical device. Device Use The Senhance Surgical System is a vital tool utilized in...
The Role of a Regulatory Professional
510(k) Submissions The New QSMR Regulatory Intelligence RIM Systems Regulatory Competencies Regulatory and Quality Role of Regulatory Professionals: Core Responsibilities Regulatory professionals play a critical role in ensuring that medical devices and pharmaceutical...
QMSR Management Responsibility
QMSR Management Responsibility The QMSR Management Responsibility requirements bring a more structured, documented, and proactive approach compared to QSR §820.20. While many concepts remain similar, organizations must focus on: - Stronger documentation of leadership...
QMSR Quality Manual
Why a Quality Manual Matters in the QMSR Transition U.S. Manufacturers Adopting ISO 13485 Will Need a Quality Manual While QSR does not mandate a Quality Manual, the QMSR ISO 13485 compliance does. This means manufacturers aligning with QMSR who do not have a quality...
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 development planningClause 7.3.3 - Design and development inputsClause 7.3.4 - Design and development outputsClause 7.3.5 - Design and development...
Tisotumab Vedotin-tftv for Recurrent or Metastatic Cervical Cancer
Product Approval for Cervical Cancer Drug Exciting news emerged from the U.S. Food and Drug Administration (FDA) on April 29, 2024, as traditional approval was granted to tisotumab vedotin-tftv, marketed as Tivdak by Seagen Inc. (now a part of Pfizer Inc.). This...
FDA Approves Anktiva for Bladder Cancer
New Drug Approval In a significant development for patients battling BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), the Food and Drug Administration (FDA) has granted approval to nogapendekin alfa inbakicept-pmln, marketed as Anktiva by Altor...
Health Alert Regarding Rare Pregnancy Complication
FDA Safety Communication In a recent health safety alert, the U.S. Food and Drug Administration (FDA) has cautioned healthcare professionals about the rare risk of intrahepatic cholestasis of pregnancy (ICP) associated with the use of thiopurines, including...
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...
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FDA: Do Not Use OTC Products to Remove Moles or Skin Tags
FDA: Do Not Use OTC Products to Remove Moles or Skin Tags Thinking about removing a mole, skin tag, or other skin lesion at home? The FDA strongly advises against it. There are no FDA-approved prescription or over-the-counter (OTC) products for removing moles,...
How Unsafe Medical Devices Can Slip Through the Cracks
Healthcare professionals and the device industry share responsibility for timely adverse event reportingGlobal device market withdrawals not always followed in US In a world of global trade and instant communication, you might assume that a medical device deemed...
FDA Issues Warning on Epinephrine Nasal Solutions
Left: BPI Labs’ FDA-approved Epinephrine Injection with blue lid on the bottle.Right: BPI Labs’ unapproved EPINEPHrine Chloride Nasal Solution with red lid on the bottle.Courtesy: FDA.A Potentially Dangerous Mix-Up The U.S. Food and Drug Administration (FDA) has...
Generic Eliquis
Generic Eliquis Editor's note: FDA originally announced the approval of generic equivalents to Eliquis in 2019, and updated that information the next year. We are publishing this information as a response to reader requests for more information about generic Eliquis....
How the Moringa Outbreaks Could Have Been Prevented
How This Could Have Been Prevented: A Quality Systems Perspective An MDP Consumer and Industry Brief After multiple...
Now the Salmonella in Moringa Is Drug-Resistant
Now the Salmonella in Moringa Is Drug-Resistant. That Changes the Stakes. An MDP Consumer and Industry Brief Salmonella...
Why These Salmonella Outbreaks Keep Happening
Why These Salmonella Outbreaks Keep Happening: “Illness First, Controls Later” An MDP Consumer and Industry Brief When...
Four Moringa-Linked Salmonella Events in Four Months
Four Moringa-Linked Salmonella Events in Four Months: The Timeline That Should Not Exist An MDP Consumer and Industry Brief...
Moringa and the “Invisible Outbreak” Problem
Moringa and the “Invisible Outbreak” Problem in Supplements An MDP Consumer and Industry Brief Most Americans assume...
Rosabella Moringa Capsules Potential Salmonella Contamination
Rosabella Moringa Capsules Recalled Over Possible Salmonella Contamination Editor's Note: This February 13 recall is 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.
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