Guidance

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The draft guidance clarifies that sex and gender are not interchangeable, but could be vulnerable in the Trump Administration as Republicans have argued against transgender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The FDA's new draft guidance for pulse oximeters requires developers to demonstrate device effectiveness across diverse skin tones to address accuracy issues, especially for people with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The US FDA has published a draft guidance document for developers of AI-enabled medical devices describing the postmarket management of their products.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.

A new FDA guidance addresses concerns about device shortages due to ethylene oxide (EtO) restrictions by allowing manufacturers of class III devices to switch sterilization sites before filing a PMA or HDE, helping to prevent supply chain disruptions and ensuring timely device sterilization.

This week, the US device center announced a pilot program to speed communications about high-risk recalls; Cardinal paid $3.9B for Advanced Diabetes Supply Group and GIA Alliance; a companion diagnostic for Merck lung cancer drug Tepmetko got FDA clearance; and more.

In its inaugural two-day meeting, the FDA Digital Health Advisory Committee discussed the promise of generative AI-enabled medical devices as well as challenges the agency faces in premarket evaluation, benefit/risk analysis, and postmarket monitoring.

Medical device manufacturers are among the companies that will face more regulatory challenges in the coming year. Two new reports look at the growing complexity of the regulatory landscape organizations will have to navigate.

New guidelines from the Medical Device Coordination Group explain the policies used by the EU in regulating ethylene oxide for device sterilization.

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.

Clinical labs and diagnostics firms alike are still grappling with the likely impact of the FDA’s final rule on LDTs, speakers said in a recent webinar. Key areas of concern: The potential for lab consolidation, lack of clarity on when clearance is necessary, research-use tests, and the hesitation imposed by an ongoing lawsuit and upcoming election.