The FDA has finalized changes to the Laboratory Developed Test (LDT) regulatory framework to address patient safety and complexity concerns. Our latest blog post provides key insights on what this means for the medtech industry.

In the dynamic realm of medical device regulation, recent strides in the European Union (EU) and the United States (U.S.) are poised to shape the trajectory of AI-powered medical technologies. The EU's proposed AI Act and ongoing discussions in the U.S. surrounding AI regulation present both challenges and opportunities for medical device manufacturers in both markets..

Streamlined data collection offers several advantages that can significantly expedite the regulatory submission process for companies operating in regulated industries, particularly for medical devices with breakthrough device designation and through the Transitional Coverage for Emerging Technologies (TCET) pathway. We share four ways that a streamlined approach helps get innovative devices to market faster.

In a significant milestone toward global quality standardization, the U.S. Food and Drug Administration (FDA) has officially adopted ISO 13485 for its new Quality Management System Regulation (QMSR). This decisive move aligns the FDA with international best practices, ushering in a more streamlined and globally consistent approach to medical device regulation.

The recently released rule, made public on January 31, 2024, is scheduled to become effective on February 2, 2026. This timeline represents a two-year implementation period, deviating from the initially proposed one-year timeframe.

Held in San Francisco in January, the J.P. Morgan’s Annual Healthcare Conference assembled industry insiders, global leaders, innovative tech creators, and investors. This annual event offered significant insight into the present industry landscape, providing valuable perspectives to shape the future ahead. Here we share our understanding of the current challenges and opportunities that are influencing the healthcare investment landscape. 

With each passing year a handful of significant events occur within the FDA regulatory landscape. Some events yield major, long term implications, while others, though much subtler, may lead to crucial shifts impacting day-to-day business operations. These occurrences, be they new guidances, proposed rule alterations, or procedural modifications, all carry implications for both immediate workflows and long-term strategic planning. Let's delve into five key events of 2023 and their ramifications on your FDA submission process.

The healthcare industry is constantly evolving, driven by technological advancements that have revolutionized patient care. Medical device accessories play a vital role in this evolution, enhancing the functionality and capabilities of existing devices. To ensure the safety and effectiveness of these accessories, the U.S. Food and Drug Administration (FDA) has developed a comprehensive framework known as the Device Accessory Guidance.

Before delving into the FDA's guidance, it's essential to understand what medical device accessories are.

The U.S. Food and Drug Administration (FDA), Health Canada (HC), and the Medicines and Healthcare products Regulatory Agency (MHRA) have recently issued a joint statement outlining five guiding principles for a Predetermined Change Control Plan (PCCP) for medical devices and machine learning. In the ever-evolving landscape of healthcare and technology, the collaboration between regulatory bodies is crucial to ensure the safety and efficacy of medical devices, especially when they incorporate machine learning algorithms. Let’s delve into three key things you should know about this important development.

In the realm of healthcare, accurate and reliable diagnostic tests are the cornerstone of patient care. The Food and Drug Administration (FDA), as the regulatory authority overseeing medical devices and diagnostics, has recently voiced concerns about the reliability of Laboratory Developed Tests (LDTs). In order to properly address such concerns revolving around LDTs, the FDA is now poised to begin reshaping the way clinical laboratories develop, validate, and market diagnostic tests with their Laboratory Developed Test (LDT) Proposed Rule.