Global Medtech Guidance Tracker: September 2022
Executive Summary
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-two documents have been posted on the tracker since its last update.
You may also be interested in...
FDA Publishes Final Guidance On Clinical Decision Support Software, Clarifies What Software Should Be Regulated As Medical Devices
In its final document, the US FDA outlines its interpretations of the four criteria for excluding clinical decision support software from being regulated as medical devices under federal law. Software must meet all four criteria to be excluded.
First Version Of EU’s MDR/IVDR Borderline And Classification Manual Tackles Tricky Topics
The EU is already familiar with borderline and classification decisions made under the medical device directives. Now, the commission has released a new MDR/IVDR manual which will grow as more decisions are made.
Final ICH Guide Supports Nonclinical Development Of Gene Therapy Products
The International Council for Harmonisation has finalized guidance that aims to facilitate the nonclinical and clinical development programs of gene therapy products, while avoiding the unnecessary use of animals.