Tracking Methods and Requirements Distributors and User Facilities

The tracking regulation distinguishes between three types of distributors— distributors, final distributors, and multiple distributors—all of which have a duty to report tracking information to the manufacturer. Both final distributors and multiple distributors are entities that make a delivery or sale to the ultimate user; the distinction between them is whether they distribute to a single patient (final distributor) or with the intention of distributing a device to more than one patient over the life of the device (multiple distributor). For purposes of tracking requirements, device-user facilities are considered either final distributors or multiple distributors (depending on whether they distribute devices to single or multiple patients). The federal government may also be considered a distributor, final distributor, or multiple distributor.

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