40+ device types in US in line for down-classification or reduction in pre-market data requirements
This article was originally published in SRA
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.
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