Medical Devices and Pharma
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Plastic Syringe Safety: FDA’s Ongoing Evaluation
Today, the U.S. Food and Drug Administration (FDA) provided a crucial update regarding the quality and performance issues associated with plastic syringes made in China. This announcement follows the agency's previous safety communication issued on November 30, 2023,...
Original FDA Safety Warning for China-made Syringes
In an announcement dated November 30, 2023, the U.S. Food and Drug Administration (FDA) issued a notice regarding the evaluation of potential device failures associated with plastic syringes manufactured in China. The FDA is actively collecting and analyzing data to...
Electrical Stimulation Devices – ESDs
Devices use controlled electrical pulses Electrical stimulation medical devices are sophisticated tools designed to deliver controlled electrical impulses to specific areas of the body for therapeutic purposes. These devices utilize various forms of electrical...
FDA Proposes Ban of Certain ESDs
Ban would affect devices used to treat aggressive/self-injurious behavior In a landmark move, the U.S. Food and Drug Administration (FDA) has proposed a ban on electrical stimulation devices (ESDs) designed to reduce or stop self-injurious or aggressive behavior. This...
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Mechanical Circulatory Support (MCS) Devices
Overview of MCS Devices Mechanical Circulatory Support (MCS) devices have transformed the landscape of advanced heart...
Recall Alert: AirLife/Vyaire Infant Breathing Systems
Class I Recall AirLife and manufacturer Vyaire are recalling specific Infant Heated Wire Circuits due to the risk that...
Avanos Recalls Ballard Closed Suction Systems
May result in non-sterile devices Avanos Medical, Inc. is recalling its Ballard Closed Suction Systems after identifying a...
The FDA Orphan Drug Program
Incentives for Rare Disease Drug Development The FDA’s Orphan Drug Program was established to encourage the development of...
FDA Grants Accelerated Approval to Multiple Myeloma Treatment
For hard-to-treat multiple myeloma On July 2, 2025, the FDA granted accelerated approval to linvoseltamab-gcpt (brand name:...
FDA Approves Alhemo for Patients with Hemophilia A or B
For Patients with Hemophilia A or B with Inhibitors The FDA has approved Alhemo (concizumab-mtci) for routine prophylaxis...
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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