Guidance
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. 25 documents have been posted on the tracker since its last update.
Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.
The FDA's final LDT ruling was struck down in federal court last month. For now, diagnostic companies can commercialize under CLIA regulations or apply for FDA approval. McDermott and Tribun Health have shared insights on the risks, pros and cons of both regulatory routes.
Many of the hundred-plus commenters to the FDA's draft guidance on AI in medical product regulation said the document was a good start but needed additional clarity and more concrete examples. Stakeholders recommended the inclusion of case studies, metrics, and clearer guidelines to enhance the utility of the guidance, which is seen as a vital step for AI integration in healthcare.
International device regulatory group IMDRF has issued a new playbook on “regulatory reliance,” which allows regulators to make use of assessments performed by trusted regulatory partners. The document is the first to offer a detailed guide on developing and implementing these agreements.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
Medtech Insight sat down with Arcadia's chief strategy officer Aneesh Chopra to discuss interoperability, industry standards and the future of health care data and AI.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 30 documents have been posted on the tracker since its last update.
Two US FDA device center websites have been restored under a restraining order. The pages now carry a disclaimer alleging they include "extremely inaccurate" content about gender; however, neither site includes any substantive discussion of trans issues.
Medtechs watch with interest as NICE, a long-standing component of market access for innovative technologies in the National Health Service, vows to get to grips with technology programs that often miss the target for developers of groundbreaking solutions.
A federal judge granted Doctors for America’s motion for a temporary restraining order directing the FDA and CDC to restore information removed from the agencies’ websites to comply with a presidential executive order targeting “gender ideology extremism.”
For the fourth time in as many years the FDA has issued a communication concerning a key accessory from Olympus used in several types of urological procedures. This time, however, the agency has added a class I recall confirmation to its original early alert on the device issued in December 2024. A device safety specialist provided Medtech Insight with a deeper understanding of the problem as well as overall scope safety.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 80 documents have been posted on the tracker since its last update.
The FDA's recent communication freeze has blocked participation in international standards development groups. The agency's absence could impact the alignment of US and international standards, potentially affecting medical device manufacturers' ability to sell products globally.
Several pages on the US FDA website related to diversity and inclusion are down, which aligns with Trump’s recent executive order on diversity, equity, and inclusion. However, the Department of Health says there's been a “short pause” in communications to allow the incoming team to get in place.
What's coming in 2025? Commissioner Makary, more digital health, and no movement on LDT regulation, predicts consultant and former FDAer Steve Silverman. See his reflections on the year ahead, as well as what he got right -- and wrong -- for 2024, here.
The director of the US FDA’s device center is sounding the alarm on the scarcity of critical devices for pediatric patients and says the agency is focused on solutions to this “unique” challenge.
The draft guidance clarifies that sex and gender are not interchangeable, but could be vulnerable in the Trump Administration as Republicans have argued against transgender medical care and that sex and gender must be congruent.
While the US FDA will not require diversity action plans for clinical trials for a while, some companies are already sending them in, a new FDA report to Congress shows.
The US FDA final guidance uses a Q&A format to help manufacturers navigate the regulatory landscape for communicating the off-label uses of their medical products to health care professionals. However, some say the final document fails to address potential free speech concerns.