In this scenario, the foreign manufacturer functions as the "OEM" (original equipment manufacturer) and owns and controls the device specifications, including those for the version of its design bearing the Private Labeler's name and brand; the foreign OEM owns and controls the Design History File; and it must integrate the private label variant into the Device Master Record.
The foreign firm is not a contract manufacturer, as FDA recognizes a "contract manufacturer" to be someone who fabricates the device in accordance with another firm's (i.e., a Specification Developer's) specifications. And the U.S. private labeler doesn't become a Specification Developer simply by arranging to have the OEM [i.e., the 510(k)-holder] make a version of the OEM's own device labeled with the private labeler's name/brand.
The U.S. company whose name and brand is on the product is just a Private Label Distributor (FDA officially/statutorily calls this a "Wholesale Distributor"). Domestic Private Label (Wholesale) Distributors are exempt from Establishment Registration and Device Listing and from Quality System Regulation compliance except for complaint files, adverse event handling, and associated record-keeping. Yet don't confuse this with FDA's "Complaint File Establishment" category and associated registration requirements; domestic Wholesale Distributors remain exempt from registration even though they're required to have complaint files.
Notwithstanding the foregoing categorizations, the U.S. firm in this scenario is also an Initial Importer and must therefore have Establishment Registration for that scope of operations.
The U.S. firm in this scenario is not a "Relabeler" (for official registration/regulatory purposes) as long as the only difference between the private label version and the OEM version is the the distributor's name and brand in place of the OEM's. But the Relabeler categorization and associated regulatory requirements will come into effect if the U.S. firm independently modifies the intended use, indications for use, or instructions for use to be different than what is covered by the OEM's 510(k)-cleared specifications.
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
ComplianceAcuity, Inc.
Golden, CO
United States
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Original Message:
Sent: 04-Dec-2019 17:33
From: Anonymous Member
Subject: Private Labeling vs. Relabeling
This message was posted by a user wishing to remain anonymous
Hello,
Given the following scenario:
A foreign manufacturer holds a 510(k) clearance for a Class II device. In addition to manufacturing the device under their own proprietary name, they contract manufacture the device for a US company to distribute under a Private label. In this instance, the foreign company manufactures, packages and applies a label that has either "Manufactured for" or "Distributed by" the US company name along with the proprietary product name of the US company on the label. The U.S. company never modifies the label. The U.S. company then takes possession, imports into the U.S. and markets/distributes the device.
Assuming this scenario is allowed with appropriate quality agreements in place, is the U.S. company considered a "Private Label Distributor" and would then register as the Initial Importer? Or does the act of adding the U.S. company proprietary product name constitute relabeling (making the U.S. company a "Relabeler")?