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3D Medical Modeling Among 39 New Entries On US FDA List Of Recognized Medtech Standards

This article was originally published in SRA

Executive Summary

The US Food and Drug Administration has made a number of changes to the list of standards it recognizes for use in medical device premarket reviews, including the addition of 39 new entries, and the withdrawal, correction and revision of existing standards1. The new entries on the list cover a wide range of topics, such as three-dimensional (3D) medical modeling, specifications for implantable breast prostheses, application of usability engineering to medical devices, and testing of absorbable stents.

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