US FDA Recognizes 46 New Medical Device Standards To Support Pre-Market Reviews
This article was originally published in SRA
Executive Summary
The US Food and Drug Administration has added 46 new standards and made a raft of other changes to its list of recognized consensus standards that medtech firms can rely on to demonstrate compliance with certain requirements for medical devices1.
You may also be interested in...
US FDA Electromagnetic Compatibility Guidance Finalized
In the final medical device electromagnetic compatibility guidance FDA clarified the scope of applications that could use this guidance and added a recommendation for sponsors to identify and consider the intended use environmental that could affect the EMC of their products.
WHO Examines Ethical Criteria For Human Challenge Trials Ahead Of Next Health Emergency
The World Health Organization is looking to finalize its guidance on the ethical criteria that should be applied to studies that involve deliberately infecting healthy individuals to speed up research.
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.