Guidance
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The draft guidance clarifies that sex and gender are not interchangeable, but could be vulnerable in the Trump Administration as Republicans have argued against transgender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.
The FDA's new draft guidance for pulse oximeters requires developers to demonstrate device effectiveness across diverse skin tones to address accuracy issues, especially for people with darker skin. The guidance includes clinical study requirements, labeling changes, and recommendations for comparing new devices to predicates.
The US FDA has finalized guidance on notifying the agency of potential device shortages during or prior to a public health emergency. The document includes a list of devices that manufacturers must notify the FDA of when they are in short supply. The guidance also clarifies that device makers voluntarily notify the agency of potential supply chain disruptions at any time.
The US FDA has published a draft guidance document for developers of AI-enabled medical devices describing the postmarket management of their products. The guidance offers a comprehensive approach to the management of risk throughout the total product life cycle of a device.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. 65 documents have been posted on the tracker since its last update.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 90 documents have been posted on the tracker since its last update.
The FDA’s final guidance on PCCPs for AI-driven devices highlights rapid advancements in health care AI, providing a roadmap for future progress. It emphasizes iterative improvements, version control, and maintaining device safety and effectiveness.
During an online seminar Tuesday, the FDA offered guidance on registration and listing requirements for lab-developed tests that will go into effect on 6 May 2026.
The agency also will not expand the guidance categories that may be issued “for immediate implementation” without prior public comment, but more guidance documents could be issued in Q&A or bulleted formats, the agency said.