Medical Devices and Pharma
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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...
Datex-Ohmeda Issues Field Correction for EVair Air Compressors
Urgent Class I Recall Notice Datex-Ohmeda Inc. has announced a field correction for its EVair and Jun-air compressors, optional ventilator accessories designed to provide an alternative source of airflow for patient support in clinical settings where wall air is...
Urgent Recall Notice for ARROW QuickFlash Catheterization Kits
Urgent Recall Notice for ARROW QuickFlash Catheterization Kits In February 2024, Teleflex and its subsidiary Arrow International issued an urgent recall notice for the ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits. Today, a...
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...
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 development planningClause 7.3.3 - Design and development inputsClause 7.3.4 - Design and development outputsClause 7.3.5 - Design and development...
FDA’s Orphan Drug Program
Expedite Development of New Orphan Drugs The FDA's Orphan Drug Program is designed to encourage the development of drugs and biologics for the treatment, diagnosis, or prevention of rare diseases or conditions, often referred to as orphan diseases. Here are the key...
Rare Pediatric Disease Priority Review Voucher program
Expedite Development of New Pediatric Drugs The legislation for priority review of rare pediatric diseases is intended to expedite the development and approval of drugs for serious or life-threatening conditions affecting children. A summary of program and its key...
Medical Devices and Pharmaceuticals
At Medical Devices and Pharma, we specialize in providing top-tier regulatory consulting services tailored to the medical device and pharmaceutical industries. Our deep understanding of policy, laws, regulations, and industry standardsand requirements will ensure your...
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...
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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....
FDA Approves New Imaging Drug Lumisight
A Significant Improvement for Surgical Oncology The U.S. Food and Drug Administration (FDA) has granted approval to LumiSight (pegulicianine) for use in adults undergoing breast lumpectomy, marking a significant advancement in surgical oncology. Lumisight, a...
FDA Issues Warning on Counterfeit Botox Products
Real Botox PackagingReal Botox Cosmetic PackagingReal Botox PackagingCounterfeit Botox Products The U.S. Food and Drug Administration (FDA) has issued a critical alert concerning the presence of counterfeit Botox products in various states, posing severe risks to...
FDA Approves XACT Carotid Stent System
A Breakthrough for Stroke Prevention Abbott Vascular Inc. has received FDA approval for its groundbreaking XACT Carotid Stent System, a significant advancement in stroke prevention technology. Approved on February 7, 2024, this innovative system offers new hope for...
FDA’s AEMS: Real-Time Drug and Device Safety Monitoring
FDA’s AEMS: The Beginning of Real-Time Drug and Device Safety MonitoringThe U.S. Food and Drug Administration has launched...
When Randomized Trials Are Not Possible
When Randomized Trials Are Not Possible: How Real-World Evidence Is Shaping FDA Drug Approvals The U.S. Food and Drug...
FDA Approves Cerebral Folate Transport Deficiency Treatment
FDA Approves First Treatment for Cerebral Folate Transport Deficiency The U.S. Food and Drug Administration (FDA) has...
FDA Streamlines Biosimilar Development to Reduce Drug Costs
FDA Moves to Streamline Biosimilar Development and Reduce Drug Costs The U.S. Food and Drug Administration (FDA) has...
FDA Inspections for Domestic and Foreign Device Manufacturers
Early Observations: Comparing FDA Inspection OutcomesStriking Difference in Inspection Outcomes for Domestic and Foreign...
A Leap in FDA Transparency – The Electronic FOIA Reading Room
Exploring FDA’s FOIA Electronic Reading RoomA New Window into Inspection Findings The U.S. Food and Drug Administration...
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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