US medtech industry warns of potential devastating effect of FDA proposed policy change
This article was originally published in SRA
Executive Summary
A policy change the US Food and Drug Administration is proposing in the medical devices arena could have a devastating effect on emerging companies, with particularly drastic implications for sponsors of devices subject to 510(k) clearance.
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.