US FDA wants reusable device makers to validate reprocessing instructions
This article was originally published in SRA
Executive Summary
The US Food and Drug Administration has issued final guidance to help manufacturers of reusable medical devices develop safer products, especially those that pose a greater risk of infection1-3.
You may also be interested in...
Endoscope Final Guidance Calls For Backflow Prevention
Irrigation accessories used with endoscopes pose a risk of cross-contamination when used on multiple patients. An FDA final guidance will require these devices to include a backflow-prevention valve to mitigate the risk.
EU Consults On What Constitutes Personal & Commercially Confidential Data In Marketing Applications
Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have proposed updating their guideline that provides for a harmonized approach to protecting personal data and business secrets in marketing authorization applications.
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.