US FDA device reviewers to use new worksheet from 1 May to capture benefit-risk determinations
This article was originally published in Clinica
Executive Summary
The US Food and Drug Administration has issued a final guidance document to explain how it considers the benefits and risks of medical devices reviewed under its pre-market approval (for high-risk products) and de novo (for low-risk products with no predicates) processes.
You may also be interested in...
Global Pharma Guidance Tracker – March 2024
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
EU Regulators Explain How To Ensure Transitioned Trials Align With CTR
Members of the EU’s Clinical Trials Coordination Group have developed harmonized requirements for updating trials that are transitioned to the Clinical Trials Information System based on a minimum set of documents.
Global Medtech Guidance Tracker: March 2024
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Fifty-nine documents have been posted on the tracker since its last update.