The FDA has recently announced a significant update to its guidance on Pre-Clinical Communication Plans (PCCPs) for AI medical devices. The updated guidance now allows developers to use PCCPs not only for AI-specific changes but also for any device modifications that maintain the original intended use and equivalence to the predicate. This means you can make a wider range of changes to your device without necessarily needing to conduct additional clinical studies.

The FDA's recent ruling on Clinical Laboratory Improvement Amendments (CLIA) Laboratory Developed Tests (LDTs) marks a large shift in regulatory oversight that will have both short and long-term implications for CLIA labs. This decision will impact laboratory operations, from regulatory compliance to operational practices. Here’s a look at how this ruling will affect CLIA labs.

In June, MedTech Impact Partners’ Kwame Ulmer joined industry colleagues to tackle the controversial topic of deciding which regulatory path to take when getting a medical device through the FDA’s rigorous approval process. In their enlightening session, medtech innovators, investors, and former regulators provided guidance on whether the Breakthrough Device Program will bring value to your device or portfolio investment based on their experience in the program, industry research, and novel insights from the 95 devices that have obtained FDA market authorization to date.

In this blog, we share key takeaways from their discussion–insights that we hope will help you in your journey to market. 

Getting a medical device through the FDA's approval process and to the patients who need them is no small feat. Join Kwame Ulmer for relevant and timely regulatory insights that provide important information to help medical device manufacturers make strategic decisions that helps them get their products over regulatory hurdles and to market faster.

In FDA in a Minute's first episode, Kwame Ulmer shares implications of the FDA's updated Breakthrough Device Designation Program and what it means for medical device companies looking to expedite their submission and path to market.

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.

The FDA issued three draft guidances to further modernize the most common regulatory application pathway-the 510(k). Here are key actions for the guidances regarding selecting the best predicate.

Having a Quality Management System (QMS) in place is key for early-stage companies looking to reach regulatory milestones and increase their value.

Moving innovative technologies from inception to market is a marathon full of hurdles. We believe that raising capital to develop a product is important and enabled by meeting regulatory and maintaining compliance. Having a solid regulatory strategy adds value for medtech companies. Knowing when, how and what topics to engage the U.S. Food and Drug Administration (FDA) is the first step in getting your regulatory plan in place. Here are a few recommended actions and our top 10 reasons to talk to the FDA.

Making it through the FDA’s rigorous approval process is a big accomplishment. Getting your medtech device or software to market and in the hands of patients who need it most is even bigger. But, that’s not the end of the journey. Have you planned for your technology’s future?

Team, technology and understanding the regulatory landscape all impact how efficiently your early stage company gets to the finish line. The better you can navigate the FDA submission process, the faster you can get your product in the hands of people who need it most. Check out MedTech Impact Partners' latest insight on how to best position your company for a successful submission.

Starting a medtech company isn't easy and getting a novel device through the FDA's approval process is challenging. Get off to the right start with MedTech Impact Partners by adding our pres-submission package to your strategy of getting your device to market faster.

Milestones are important and that’s why we are thrilled to celebrate five years at MedTech Impact Partners! We couldn’t have grown to this point without the wonderful support of our global network of partners and outstanding clients.