US FDA exempts over 100 devices from 510(k) requirements
This article was originally published in Clinica
Executive Summary
The US FDA has exempted over 100 Class I and II medical devices from pre-market notification, or 510(k), requirements as it believes these products are sufficiently well understood and do not present risks that require pre-market notification review to assure their safety and effectiveness.
You may also be interested in...
Simplified Clinical Trial Transparency Rules To Go Live In The EU In June
A new version of the EU Clinical Trials Information System’s public portal will integrate the functionalities of the streamlined transparency rules.
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.