March 13, 2023

FDA Medical Device “Distributor”, “Private Label Distributor”, and Label Overview

For the U.S. medical device jurisdiction, the FDA doesn’t automatically consider the person named on the label to be the manufacturer.  This is contrary to other jurisdictions like Europe’s Union and Canada.  Accordingly, for the U.S., if the person named on the label is actually just a distributor for whom a distributor-branded version of the device has been made/authorized by the product’s manufacturer or specification developer, then the FDA categorizes that named person as a “wholesale distributor”.  More specifically, FDA calls such a distributor a “private label distributor” and officially defines that as a distributor that obtains a device from a manufacturer with the label already applied and that does not repackage or otherwise alter the device’s package or label.

The “wholesale distributor” category is contingent on FDA’s official definition: Any person (other than the manufacturer or the initial importer) who distributes a device from the original place of manufacture to the person who makes the final delivery or sale of the device to the ultimate consumer or user.  In this definition, my understanding is that “the person who makes the final delivery” = a courier service, a 3PL, etc., while “the person who makes final sale to the ultimate user” = a retailer.  Remember also FDA’s official definitions of “manufacture” [making by chemical, physical, biological, or other procedures of a medical device (short paraphrased summary)] and “manufacturer” [any person who designs, manufactures, fabricates, assembles, or processes a finished device (short paraphrased summary)]. Ultimately, if the operations in which the wholesale distributor is engaged stray beyond the boundaries of the U.S. wholesale distributor definition and into the manufacture/manufacturer definitions, then a firm’s eligibility for the wholesale distributor categorization can become disqualified.

An associated U.S. label requirement [21 CFR §801.1(c)] for private label distributors is to, on the label, identify the distributor with the clarifier “Distributed by” or “Manufactured for“.  But I suggest that “Distributed by” more succinctly addresses the main intent of 21 CFR 801.1(c) because “Manufactured for” is also used for manufacturers who are specification developers.

Remember also that the ISO 15223-1 symbols aren’t generally required by U.S. device labeling regulation, notwithstanding possible technology-specific symbols that might be required in some cases.  Instead, the “Manufactured for” or “Distributed by” clarifier is what is required, specifically, when the person named on the label isn’t the manufacturer.  Yet if an ISO 15223-1 symbol is used for the U.S. labeling to designate the role of the person on the label, then the distributor symbol is the proper symbol for a U.S. distributor.  But you will need to reconcile this with the competing fact that, for jurisdictions like Europe and Canada where the person named on the label is by default considered the manufacturer, then the 15223-1 distributor symbol isn’t appropriate there.