The US FDA does not have a specific document called a “technical file,” but it requires various documentation depending on the type of product and the regulatory pathway.

For medical devices, the equivalent documentation may include:

• Premarket submissions such as 510(k) Premarket Notifications, Premarket Approval (PMA) applications, or De Novo requests.
• Design control documentation demonstrating compliance with FDA Quality System Regulation (QSR) requirements
• Risk management documentation following ISO 14971.
• Clinical data (if applicable).
• Labeling and packaging information.
• Manufacturing information and quality control processes.




The FDA also requires establishment registration and device listing for manufacturers and initial distributors of medical devices.


In summary, the US FDA Technical File is a vital document for manufacturers seeking to market their products in the US. It provides comprehensive evidence of compliance with applicable regulations and helps ensure the safety and performance of products placed on the US market.