Guidance
During an ECRI-hosted webinar on AI-enabled diagnostics, a panel of experts discussed the promise and risks that come with the technology for both physicians and patients alike.
A new final guidance document from the US FDA lays out premarket considerations for devices intended to help treat obesity, including clinical trial design, labeling, and safety concerns. The guidance also calls for sponsors to consider patient perceptions in evaluating device effectiveness.
The FDA’s device center has received a second citizen petition relating to the NarxCare algorithm by Bamboo Health. Both petitions argue that NarxCare qualifies as a regulated clinical decision support product, but it is not clear whether the second petition will succeed where the first failed.
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.
US FDA staff discussed a newly in effect guidance document on the use of real-world evidence in medical device submissions in a recent webinar. The new guidance broadens the set of data sources the agency will accept, while also clarifying the FDA’s expectations for sponsors using RWE.
The US FDA hosted a virtual town hall as a follow-up to final guidance the agency issued last month, which outlines its policy on general wellness medical devices that the agency considers low risk.
The US FDA has published an updated inspections manual detailing how it will conduct investigations going forward under its new regulatory framework. Medtech Insight talked to a couple of regulatory experts about the key changes to the new protocol.
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.
The US FDA has published a draft guidance on clinical performance testing and evaluation for premarket submissions from manufacturers of cuffless blood pressure measuring monitors, which the agency generally regulates as class II devices.
Wishes for 2026 from our medtech experts focused on value-based care, faster reimbursements, and better collaboration. Key ideas included enhancing patient engagement, reducing waste, and aligning coverage policies to improve health outcomes and innovation.
As medtech moves toward 2026, experts highlight increased regulatory complexities, particularly around AI, cybersecurity, and device user fees. Urgent regulatory updates are needed to keep pace with rapid technology changes while ensuring patient safety and operational efficiency.
The EU's medtech regulatory landscape is shifting, influenced by the Commission's proposed changes. Experts note opportunities and concerns emerging from these reforms, highlighting the need for transparency, efficiency, and adaptability to new technologies by 2026.
Stay current on regulatory guidelines from around the world with Medtech Insight’s Guidance Tracker. Over 70 documents have been posted on the tracker since its last update.
The FDA’s revised guidance emphasizes biological sex in clinical trials, removing references to gender and health equity considerations.
The UK health care products regulatory agency is inviting industry to share its views on how artificial intelligence in health care should be regulated, with input set to shape future rules and guidance.
Makary Touts ‘AI Revolution’ In Announcing Guidance Docs On Wellness Products, Decision Support Tool
FDA Commissioner Marty Makary announced new guidance documents on wellness products and decision support tools focused on AI technology at CES in Las Vegas. The documents aim to reduce regulatory hurdles and promote innovation while ensuring public safety.
The US FDA’s General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee convened Wednesday to discuss germicidal ultraviolet (GUV) devices as a mode of disinfection, a technology that has emerged since the COVID-19 pandemic.
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.
In September, the US FDA asked the public to weigh in on how AI-enabled medical devices perform in real-world settings. With the comment period now closed, the agency has heard back from dozens of stakeholders on how the agency can use clinical outcomes to better understand these devices.
The UK Medicines and Healthcare products Regulatory Agency said its RegulatoryConnect program “no longer offers value for money for UK taxpayers” and will be closed just 19 months after its April 2024 launch.