Master file

Master files let a supplier share confidential details with FDA without handing them to the device company. The device sponsor refers to the file in its own submission, with a letter of authorization from the file holder.

Master file means a reference source that a person submits to FDA. A master file may contain detailed information on a specific manufacturing facility, process, methodology, or component used in the manufacture, processing, or packaging of a medical device.

21 CFR, 814.3