FDA has changed certain medical device establishment registration and listing requirements in accordance with the Medical Device User Fee Amendments of 2012 (MDUFA III), signed into law on July 9, 2012, and pursuant to the Food and Drug Administration Safety and Innovation Act (FDASIA).1 All establishments required to register must pay the medical device user fee. The deadline for medical device registration under the new requirements has been extended to January 31, 2013.2
Under MDUFA III, manufacturers (including contract manufacturers and manufacturers of custom and export-only medical devices), sterilizers, kit assemblers, contract packagers, reprocessors, relabelers, reprocessors, remanufacturers, and specification developers must register and list the medical devices they produce.3 In this regard, a specification developer is an establishment that develops specifications for a device that is distributed under the establishment’s name but which performs no manufacturing. This includes establishments that, in addition to developing specifications, also arrange for the manufacturing of devices labeled with another establishment’s name by a contract manufacturer.4
Under MDUFA III, initial importers of medical devices must register with FDA and identify the manufacturers of the devices they import. Non-U.S. manufacturers must identify all known U.S. importers of the devices they export. In addition, device establishments located in foreign trade zones must now register and list their devices with FDA and identify the foreign trade zone location. FDA has also defined a new establishment type, the "Complaint File Establishment," and entities that only handle complaints and that previously registered as manufacturers or specification developers must change their type identity when registering for 2013.
Contract manufacturers, many of whom have previously not been required to register and list, have questioned whether and when their registration and listing is required. Under MDUFA III, all contract manufacturers of "finished devices" must register and list the devices they make, whether or not they put them into commercial distribution under their own names.5 If a contract manufacturer of a finished medical device markets the product under its own name, it must list the device before it is placed on the market. However, if a contract manufacturer makes a finished medical device for a third party that commercializes the device, it must wait until the device is listed by that third party specification developer before listing the product in its own name.6
In fact, a device must first be listed by the manufacturer, specification developer, single-use device reprocessor, remanufacturer, or repacker/relabeler before a foreign exporter, contract manufacturer, or contract sterilizer can list it. At the first listing of the device, all the proprietary (brand) names under which a finished device is currently sold must be identified and subsequently updated with the annual registration renewal.
Note that combination products (device/drug combinations) for which a 510(k) or PMA number was assigned must be listed with the Center for Devices and Radiological Health (CDRH). This includes products cleared by 510(k)s and PMAs reviewed by Center for Biologics Evaluation and Research (CBER) that have a "BK" or "BP" number. While a company must only list a product with the center that took the lead on the combination’s review, a company may choose to additionally list the device/drug product with the Center for Drug Evaluation and Research (CDER).
Importantly, a contract manufacturer must only register with FDA if it makes a "finished" device, that is, if the product it makes meets the definition of, and is usable by itself, as a medical device. FDA has clarified the difference between a device component and a "finished medical device," stating that a component of or an accessory to a medical device is considered a "finished medical device" if it is packaged or labeled for commercial distribution for health-related purposes to an end user. This is so whether it is marketed by the contract manufacturer or by a third-party specification developer.7
As FDA stated in the preamble to the Final Rule for current medical device good manufacturing practices, "devices that have been manufactured or assembled, and need only to be sterilized, polished, inspected and tested, or packaged or labeled by a purchaser/manufacturer are clearly not components, but are now in a condition in which they could be used, therefore meeting the definition of `finished device.’"8 Thus, a manufacturer must register and list a product if the product is usable by itself as a medical device, if FDA has classified it as a medical device or if the product meets the "device" definition.9
However, a manufacturer of a component or accessory is not required to register with FDA or to list its components/accessories with the agency if the component or accessory is not itself a finished medical device and it is distributed only to a finished device manufacturer.
Other entities that are not required to register and list under MDUFA III include manufacturers of device components sold only to the finished device manufacturer, manufacturers of devices subject to an Investigational Device Exemption (IDE), domestic distributors that are not also initial importers, refurbishers (establishments that restore used devices to the original manufacturer’s operating specification), entities that provide only specification consulting services, and import agents, brokers and other parties that do not take first possession of a device imported into the United States.10