Hi Yasser,
This generally refers to a FDA requirement in a PMA that the sponsor conducts a post-market clinical study to gather additional clinical data regarding the device. As most pivotal clinical studies to support approval have inclusion/exclusion criteria that are geared to provide favorable data for the submission, the goal of the post-market study is to gather "real world" data. The FDA approval order would set out the expectations which usually includes a number of individuals expected in the study cohort, and the submission of the protocol for the post-market study would likely be among the first supplements to the submission. Generally speaking, among the requirements is the need for annual reporting of the status of the study, and of course immediate reporting of serious adverse events through both the MDR and post-market surveillance. Companies have been cited in Warning Letters for not diligently pursuing the post-market study goals and reporting set out in the protocol. I am not aware of any template, as all devices are different, patient populations and indications vary, as well as FDA expectations.
Regards,
James