Guidance
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.
The European Commission has issued a draft document setting out the potential conditions for joint HTA scientific consultations on medical devices taking place in parallel with consultations with an expert panel.
Device supply interruptions and withdrawals, now common in the EU, could threaten patient safety. Newly issued manufacturer guidance from the European Commission is intended to improve transparency and minimize disruption.
The US FDA has published a final guidance document providing stakeholders with a framework for various safety evaluations they should consider when developing medical products for newborns, including devices. The guidance focuses on long-term evaluations of neurodevelopmental safety.
The Design for Life roadmap will help medtech companies comply with the UK NHS’s Net Zero 2045 greenhouse gas emissions target. A dedicated medtech innovation center is mooted.
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.