As of Oct. 1, 2012, medical device establishments will be required to follow
these new registration/listing requirements and responsibilities:
All proprietary names under which a device is
marketed must be reported, at a minimum, when a device is first listed and
during the annual update of registration and listing information.
Drug/device combination products must be
identified as a combination product, and the type of combination product
(e.g., convenience kit, prefilled drug delivery device, etc.) must be selected
from the list displayed in the FDA Unified Registration and Listing System
All contract manufacturers and sterilizers of
finished devices must register and list regardless of whether they put the
device into commercial distribution or return the device to the manufacturer
or specification developer.
Initial importers must identify the manufacturers
of the devices they are importing.
Foreign establishments exporting devices to the
U.S. must identify all known U.S. importers of their devices.
Before a foreign exporter, contract manufacturer
or contract sterilizer can list a device, it must be listed by the
manufacturer, specification developer, single-use device reprocessor,
remanufacturer or repacker/relabeler.
Establishments that only handle complaints and
previously registered as manufacturers or specification developers should
change their establishment type to “Complaint File Establishment” as required
by 21 CFR 820.198.
Establishments located in foreign trade zones must
now register and list, as well as identify themselves as being located in a
foreign trade zone.
All establishments that are required to register
must now pay the annual registration user fee as required by the Food and Drug Administration Safety and Innovation Act
On Sept. 12, 2012, FDA released a document entitled “Frequently Asked Questions about the New Device Registration and
Listing Requirements.” The purpose of the FAQs is to assist medical device
establishments in understanding and complying with the new requirements and
responsibilities for registration and listing.
For advice on whether your company must comply with these new requirements,
and how to do so, please contact us.