For international medical device manufacturers, shipping a product to the United States can feel like the final step in entering the U.S. market. From FDA’s perspective, however, importation is also a compliance checkpoint. Before a medical device is admitted into U.S. commerce, FDA may verify whether the manufacturer, device, and importer meet applicable regulatory requirements. When a device requires premarket authorization — including a 510(k) — attempting to import the pr

As U.S. federal enforcement becomes more focused on border security, importer accountability, and supply chain transparency, foreign medical device manufacturers may need to take a closer look at how their products actually enter the U.S. market. Over the past year, much of the public discussion around U.S. border enforcement has centered on immigration. Immigration enforcement has clearly become a major federal priority. At the same time, however, the federal government is a

**Medical device authorizations are increasing in 2026. But for manufacturers, the path to market may still be taking longer than expected.** For medical device manufacturers preparing to enter the U.S. market, one question is always critical: **How long will FDA review take?** In 2026, that question may be becoming more complicated. Recent industry analysis shows that the FDA has authorized more medical devices during the first half of 2026 compared with the same period in 2

In October 2025, the FDA issued a safety communication warning that serious complications had been reported with certain uses of radiofrequency (RF) microneedling devices. Nearly a year later, the warning is still shaping how the aesthetics and skincare industry talks about these treatments — and it's worth understanding exactly what it says, and what it doesn't. What RF Microneedling Actually Is RF microneedling combines traditional microneedling — tiny needles that create c

The FDA has published its Medical Device User Fee Amendments, or MDUFA, fee schedule for Fiscal Year 2027. The new fees will apply from October 1, 2026, through September 30, 2027. Medical device manufacturers planning submissions during this period should update their regulatory budgets and submission timelines accordingly. FY2027 Annual Establishment Registration Fee The Annual Establishment Registration Fee for FY2027 is: $13,785 Most medical device establishments required

The U.S. Food and Drug Administration (FDA) recently announced the first participant selected for its Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot program, an initiative that could significantly influence how digital health technologies are evaluated and introduced into clinical practice. Rather than representing a new device approval, the announcement reflects a broader evolution in regulatory thinking—one that recognizes the unique nature of software-driven

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

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