Biocompatibility has long been a critical part of medical device development and FDA submissions. But FDA continues to move away from treating biological safety as a simple checklist of tests and toward a more comprehensive, risk-based evaluation of the finished device. That shift is becoming even more important with the introduction of ISO 10993-1:2025. On September 9, 2026, FDA held the first in a series of Town Halls addressing recent updates to ISO 10993-1:2025 and approa

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