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.
1997年通过和实施的立法，2012年提炼，并在FDA的2017年指导下进一步澄清，现在允许FDA在基于新颖的设备的风险概况的适当监管下简化分类过程。