For companies looking to launch a novel, low-to-moderate risk medical device, the traditional pre-market notification 510(k) submission pathway may not be an option if no comparable (also known as ‘predicate’) device already exists in the market.
立法于1997年通过并实施，于2012年进行了完善，并在FDA的2017年指南中进一步阐明了，现在允许FDA根据新设备的风险概况在适当的监管水平下简化分类过程。