Medical Devices and Pharma
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SonarMed Inc Recalls Airway Acoustic Sensors
Urgent Class I Recall Notice SonarMed Inc. has issued a Class I recall for its Airway acoustic sensors due to a critical issue that could lead to serious health consequences for patients. The U.S. Food and Drug Administration (FDA) has identified this as the most...
DeRoyal Industries, Inc. Recalls Tracecarts
Urgent Class I Recall Notice DeRoyal Industries, Inc. has issued an urgent recall notice for certain Tracecarts containing 16FR Urine Meter Foley under recall by Nurse Assist. Identified by the FDA as a Class I recall, the most serious type, the use of these devices...
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...
Medical Device Labeling
In the world of medical devices, proper labeling isn't just a regulatory requirement, it is a vital component of patient safety, product usability, and market access. Whether you're a manufacturer navigating FDA regulations, a distributor handling multilingual...
QMSR Clause 8 – Measurement Analysis and Improvement
Using Data to Drive Quality, Risk Control, and Continuous Improvement Clause 8 of ISO 13485:2016 defines how organizations monitor performance, analyze data, and take action to ensure their quality management system (QMS) remains effective. At its core, this clause...
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
Ensuring the Organization Has the Capability to Deliver Safe and Effective Medical Devices Clause 6 of ISO 13485:2016 defines the requirements for providing and managing the resources necessary to implement, maintain, and improve a quality management system. At its...
FDA Fast Track Program
Fast Track for Serious Conditions - Unmet Medical Needs The FDA's Fast Track program is designed to facilitate the development and expedite the review of drugs and biologics intended to treat serious conditions and fill an unmet medical need. Following are key...
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...
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The FDA Orphan Drug Program
Incentives for Rare Disease Drug Development The FDA’s Orphan Drug Program was established to encourage the development of drugs for rare diseases that affect fewer than 200,000 people in the U.S. Because these diseases often lack market incentives due to small...
A Dangerous and Unapproved Drug Sold as a “Cure”
The dangers of tianeptine FDA warns that tianeptine is sold online and even at gas stations as a supposed treatment for depression, anxiety, pain, and opioid withdrawal. But don’t be fooled — this drug is not approved by the FDA for any medical use in the U.S. and has...
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...
When Generic Drugs Are Not Equivalent
Fighting for BreathLung transplant patient Hannah Goetz’s life depended on the generic version of a critical drug. It was...
Labeling Correction for TRUE METRIX® Blood Glucose Meters
Labeling Correction for TRUE METRIX® Blood Glucose Meters Highlights the Critical Role of Clear Error Messaging Trividia...
Proposed Bill Would Increase Drug Labeling Transparency
Proposed Legislation would Require Generic Drug Labels to Bear Manufacturer, Location, and Key Suppliers ProPublica's RX...
Major Manufacturers of Animal Orthopedic Devices
Manufacturers of Common Veterinary Orthopedic Product Families The veterinary orthopedic device market includes a mix of...
Animal Orthopedics Device Types
Major Categories of Animal Orthopedic Devices Animal orthopedic medicine has evolved into a sophisticated surgical...
FDA Removes Autism Treatments Warning
Chlorine Dioxide, Raw Camel Milk: The FDA No Longer Warns Against These and Other Ineffective Autism Treatments The FDA has...
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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