40+ device types in US in line for down-classification or reduction in pre-market data requirements
This article was originally published in SRA
Executive Summary
The US Food and Drug Administration is inviting stakeholder feedback on its proposal to down-classify 21 types of devices, including urethral stents and catheters for chorionic villus sampling, from high- to medium-risk (ie from Class III to Class II). Also, comments are being sought on its proposal to reduce certain pre-market data collection requirements, or to shift these to post-market phase, for another 21 types of devices, including silicone breast implants and several IVDs1.
You may also be interested in...
EU Regulators Explain How To Ensure Transitioned Trials Align With CTR
Members of the EU’s Clinical Trials Coordination Group have developed harmonized requirements for updating trials that are transitioned to the Clinical Trials Information System based on a minimum set of documents.
Global Medtech Guidance Tracker: March 2024
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Fifty-nine documents have been posted on the tracker since its last update.
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.