Private Labeling of Medical Devices in the United States

This document is a guide on the private labeling of medical devices in the United States. It outlines key definitions, types of private label medical devices, and regulatory considerations involved in the process. The guide explains that a private label medical device is one that is identical to an original manufacturer's device but is marketed under a different name. It discusses the roles of private label distributors and original manufacturers, emphasizing the importance of compliance with FDA regulations. The document details the establishment registration and device listing requirements, as well as labeling requirements, including the Unique Device Identification (UDI) system. It also highlights the responsibilities of private labelers in ensuring compliance with FDA standards, particularly in relation to device registration and UDI submission. Additionally, the guide presents best practices for establishing supplier quality agreements to clarify responsibilities and prevent compliance gaps.