2024年8月22日，美国食品药品监督管理局（FDA）发布了《医疗器械预定变更控制计划》的指南草案，PCCP 是描述将对器械进行哪些修改以及如何对修改进行评估的文件。制造商通过在上市申报资料中纳入PCCP可预先明确并申请器械预期修改的上市前授权，不需要在修改实施前再次提交上市前申请或获取额外FDA授权，这一前提是所实施的变更与已批准的PCCP保持一致。换句话说，作为器械上市前申请的一部分，获得FDA对PCCP的授权允许制造商在一段时间内根据PCCP修改其器械，而无需在每次实施重大变更之前都要获得FDA的单独授权。

   A PCCP is thedocumentation describing what modifications will be made to a device and how the modifications will be assessed.

    By including a PCCP in a marketing submission for a device, manufacturers can prospectively specify and seek premarket authorization for intended modifications to a device without needing to submit additional marketing submissions or obtain further FDA authorization before implementing such modifications-provided the changes are implemented consistent with the PCCP that has been reviewed and established through a device marketing authorization (referred to hereafter as the "authorized PCCP"). In other words, obtaining FDA authorization of a PCCP as part of a marketing submission for a device allows a manufacturer to modify its device over time in accordance with the PCCP instead of obtaining separate FDA authorization for each significant change prior to each implementation.