Medical care is no longer limited to hospitals, clinics, and professional healthcare facilities. Patients increasingly use medical devices in their homes to monitor chronic conditions, administer treatments, support rehabilitation, manage pain, collect diagnostic information, and communicate health data to healthcare providers. This transition creates meaningful benefits. Home-use technologies can improve access to care, support earlier intervention, reduce unnecessary hospit

The FDA medical device recall process is designed to protect patients when a product may create an unacceptable safety risk. Recently, the FDA classified Bolton Medical’s Relay Pro Thoracic Stent-Graft System recall as a Class I Recall, highlighting the importance of robust quality management systems throughout the entire medical device lifecycle. For medical device manufacturers, this case provides an important lesson: Regulatory compliance does not end after FDA clearance o

Cybersecurity has become one of the fastest-evolving areas of medical device regulation. While the U.S. FDA already requires cybersecurity documentation for many connected medical devices submitted after March 2023, lawmakers are now proposing legislation that could significantly expand FDA's oversight beyond new product submissions. Recently, Senator Tom Cotton introduced the Countering Chinese Cyberthreats for Patients (Countering CCP) Act, a bill that would require the FDA

The U.S. FDA has granted De Novo classification to the Claria System, an innovative medical device developed by Claria Medical to improve tissue containment and removal during minimally invasive hysterectomy procedures. The authorization represents an important milestone—not only for the company, but also for the broader medical device industry. What Is the Claria System? The Claria System is designed to make tissue extraction during minimally invasive hysterectomies safer an

In June 2026, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Huons Co., Ltd. following an inspection of its sterile injectable manufacturing facility in Jecheon, South Korea. While Warning Letters are not uncommon in the pharmaceutical industry, this case stands out because it goes far beyond isolated documentation issues. The FDA concluded that the company's manufacturing systems, laboratory controls, and quality oversight failed to comply with Curren

FDA Medical Device Cybersecurity Guidance: Enforcing Section 524B of the FD&C Act to Secure Connected Devices via Strict SBOM Requirements for Medical Devices As medical devices become increasingly interconnected through hospital networks, wireless configurations, and cloud infrastructure, they face a rising wave of sophisticated digital threats. In response to these vulnerabilities, the U.S. FDA finalized its comprehensive FDA medical device cybersecurity guidance, titled "C

Why Generative AI Medical Devices Face Unique Hurdles Under the Current FDA Regulation on AI Medical Devices Artificial Intelligence is rapidly reshaping healthcare, prompting regulatory bodies worldwide to reevaluate their approval frameworks. While thousands of software functions are currently listed on the official FDA AI-enabled medical devices list, a critical shift is occurring with the emergence of advanced technologies like Generative AI medical devices. Notably, Sout

How the 21 CFR Part 820 Amendment Harmonizes Global Quality Management Systems with the FDA QMSR Final Rule The U.S. Food and Drug Administration has officially enacted one of the most significant modernizations to its medical device quality system regulations in decades. By issuing the highly anticipated FDA QMSR final rule (Quality Management System Regulation), the agency has substantially replaced the long-standing Quality System Regulation (QSR) framework. This massive r

If you find yourself sneezing, sniffling, and constantly reaching for tissues in California, you're not alone.

Groundbreaking technology that will change how heart transplants are done nationwide has now received approval from the U.S. Food and...