US reclassifies certain software, hardware used with devices as low-risk
This article was originally published in Clinica
Executive Summary
The US Food and Drug Administration has issued a final rule that reclassifies certain software and hardware products used with medical devices as Class I or low-risk products. Until now, these devices were considered to be either Class III (high-risk) devices requiring pre-market approval or accessories to an existing medical device.
You may also be interested in...
EU Regulatory Assessors Get AI Boost In Reaching Scientific Decisions
The European Medicines Agency is training scientific staff working for the European medicines regulatory network in how to use a new AI-powered search engine that allows them to easily retrieve information on regulatory precedents.
EMA Hopes New Requirement Will Make Companies Stick To Their Filing Plans
An additional form that marketing authorization applicants must now complete during the pre-submission stage emphasizes the importance of companies providing accurate information on their intended submission date.
EMA To Get The Ball Rolling On Making CTIS Global
The European Medicines Agency wants to further improve the visibility of data in the Clinical Trials Information System by establishing it as a World Health Organization primary registry.