Guidance
European Commission acts on call from industry for more guidance from notified bodies around innovation.
The US FDA has released its annual list of planned guidance documents for the upcoming fiscal year. While many topics on the list are familiar, a new “Under Construction” list shows rising priorities.
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 final guidance to provide clarification for industry and agency staff on federal regulations of diagnostic X-ray equipment.
Guidance documents issued 30 September explain how makers of air powered dental handpieces and air motors, dental cements, dental ceramics, and dental impression materials can bring their products to market by demonstrating compliance with established criteria, without a direct comparison to a predicate device.
Patient centricity, diversity, innovation and transparency are key topics in the World Health Organization’s new guidance that recommends best practices for clinical trials and complements existing international guidance in this area.
The US FDA has published a trio of draft guidance documents for its Assessment Scheme for Conformity Program, which began as a pilot in September 2020 to capitalize on the role of standards in the regulation of medical devices.
The US FDA is providing recommendations for sponsors conducting clinical trials outside traditional settings, such as individual homes, mobile research units, and remotely via telehealth participation. The agency says the guidance is part of an overall effort to advance how trials are designed and run.
The US FDA has issued a draft guidance document providing recommendations on how device firms can collect patient preference data to share with the agency as it reviews applications. The current draft supersedes final guidance the agency published in 2016.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Nearly 80 documents have been posted on the tracker since its last update.
The Food and Drug Administration’s final guidance outlines the agency’s thinking for sponsors submitting de novo requests electronically, which they must starting in October 2025.
This week, a medical group sued the FDA to block a lab-developed test rule; the FDA published guidance on device classifications; Defibtec issued a recall of its chest compression device and ICU Medical updated instructions for its infusion pump batteries; Maui Imaging raised a $4m DOD grant to put imaging tech into military-based trauma units.
The US FDA has published draft guidance for predetermined change control plans for medical devices along with recommendations for sponsors including them in marketing submissions to the agency.
The US FDA has published a discussion paper as part of an effort to ensure all patients have timely access to safe and effective medical devices. The agency says the paper fits into a larger strategy of promoting health equity and is seeking public comment on the initiative.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Nearly 30 documents have been posted on the tracker since its last update.
The document explains how user fees for combination products are assessed and administered, as well as waiver possibilities.
The FDA has published final guidance to assist developers of medical devices designed to treat opioid use disorder, along with considerations for sponsors of clinical studies to evaluate those devices.
The FDA’s updated guidance on internet responses to misinformation adds considerations for a post-COVID, social media influencer world.
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.
The US FDA has published draft guidance for developers of drug delivery devices listing recommendations related to device design outputs essential for establishing and assessing the performance of their products.