Medical Devices and Pharma
Medical device and pharmaceutical regulatory consulting and health safety informationHeadlines
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...
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...
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 ...
QMSR Clause 7 – Product Realization
ISO 13485 Clause 7 - Product Realization Clause 7 of ISO 13485, titled Product Realization, outlines the structured approach medical device manufacturers must take to design, develop, produce, and deliver devices that meet customer needs and regulatory requirements....
QMSR Clause 6 – Resource Management
ISO 13485 Clause 6 - Resource Management Like other QSR-to-QMSR transition themes, there is a close alignment between 21 CFR 820.20(b), 820.25, and 820.70 ISO 13485 Clause 6 in their subjects of resources, personnel, training and documentation, awareness of work...
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
Transitioning from QSR to 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...
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...
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...
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Beware of False “Cures” for Autism
Unapproved and Potentially Harmful Products Autism Spectrum Disorder (ASD) affects about 1 in 68 children, and while early behavioral therapies can help improve symptoms, there is no cure for autism. Unfortunately, some companies promote unproven products that falsely...
Formaldehyde in Hair Smoothing Products: Know the Risks
Know the Risks Before You Straighten Thinking of straightening or smoothing your hair? Many salon hair treatments release formaldehyde gas — a known human carcinogen — when heated. This chemical can pose serious short- and long-term health risks to both clients and...
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...
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Do Not Blame FDA for Lax Oversight of Dietary Supplements
A Regulatory System Designed to Fail The recent recalls involving contaminated moringa leaf powder should alarm every company that manufactures, imports, or sells dietary supplements in the United States. They highlight a reality that consumers rarely understand, and...
Has Industry Self-Regulation Been Effective?
Has Industry Self-Regulation Been Effective? Supplement industry self-regulation has helped in limited ways, but it has not been sufficient to ensure reliable safety. What has worked Voluntary GMP certifications (e.g., NSF, USP, Informed Choice) A minority of...
Why DSHEA Reform Must Be a Priority
Why DSHEA Reform Must Be a Priority The recent wave of moringa-related contamination recalls – touching national retail chains and rippling through dozens of contract manufacturers – has forced an uncomfortable question into public view: How was a single tainted...
The 30-Year Consequences of Faulty Supplement Legislation
How a 1994 Law Created Today’s Dietary Supplement Crisis In light of the current moringa contamination recalls affecting national retailers and dozens of downstream manufacturers, many consumers are asking the same question: How did this happen? The answer leads us...
Invisible Outbreak of Contaminated Supplement Ingredients
Contaminated Products Distributed Nationwide How a contaminated Moringa shipment was spread across the U.S. supplement market, and why there were no additional recalls. Sam’s Club announced a recall of its Member’s Mark Super Greens powder in late October 2025 due...
Organic Moringa Powder Recalled for Salmonella Contamination
On November 12, organic moringa powder importer and packager Africa Imports issued a recall notice for its products dating back to June 5. The recall notice was published on the FDA website. Following are details of the recall. Who Issued the Recall Africa Imports...
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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.
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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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