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FDA Extends UDI Compliance Date for Implant Labelers

On November 19, 2014, the U.S. Food and Drug Administration (FDA) published a letter to implant labelers granting the labelers an extension to comply with the Unique Device Identification labeling requirements established in September 2013.  Originally, class III implant labelers were required to comply by September 24, 2014, while class I and II implant labelers had to comply by September 24, 2015.  The medical devices covered by the extension (which are listed at the end of this blog) now have until September 24, 2016 to comply with the labeling requirements.

FDA wants the label containing the Unique Device Identifier (UDI) to accompany implants up to the point of implantation, but implants are often sold unsterilized.  Because of this, implants are often separated from their labeling and packaging in order to be sterilized before implantation.  FDA is extending the labeling requirements for implants to allow time to develop and implement a safe and effective solution that will allow the UDI to be available and recorded at an implant’s point of use.

The extension applies only to the UDI labeling requirements.  All implant labelers must still comply with the Global Unique Device Identification Database (GUDID) requirements by the original compliance dates.  The labeling extension applies to all medical devices that fit the following criteria:

  1. The medical device is a single use implant
  2. The medical device is intended to be sterilized before use
  3. The medical device has one of the following product codes:

NHA                Implant, endosseous, root-form, abutment
OAT                 Implant, endosseous, orthodontic
DYX                 Lock, wire, and ligature, intraoral
MQN                External mandibular fixator and/or distractor
JEY                  Plate, bone
NEI                  Prosthesis, condyle, mandibular, temporary
DZL                 Screw, fixation, intraosseous
EZX                 Mesh, surgical, metal
HCH                Clip, aneurysm
GXR                 Cover, burr hole
GWO               Plate, cranioplasty, preformed, alterable
GXN                 Plate, cranioplasty, preformed, non-alterable
HBW               Fastener, plate, cranioplasty
JXG                  Shunt, central nervous system and components
OWI                Bone fixation cerclage, sublaminar
JDQ                 Cerclage, fixation
HSB                Rod, fixation, intramedullary and accessories
KTT                Appliance, fixation, nail/blade/plate combination, multiple component
LXT                Appliance, fixation, nail/blade/plate combination, multiple component, metal composite
KTW              Appliance, fixation, nail/blade/plate combination, single component
JDP                 Condylar plate fixation implant
JDO                 Device, fixation, proximal femoral, implant
JDS                 Nail, fixation, bone
HRS                Plate, Fixation, Bone
JDR                 Staple, fixation, bone
HTN               Washer, bolt nut
JEC                 Component, traction, invasive
MBI                Fastener, fixation, nondegradable, soft tissue
HTY               Pin, fixation, smooth
JDW               Pin, fixation, threaded
OUR               Sacroiliac joint fixation
HWC               Screw, Fixation, Bone
LYP                 Accessories, Fixation, Spinal Interlamina
KWP               Appliance, fixation, spinal interlaminal
NQW              Orthosis, spine, plate, laminoplasty, metal
PEK                 Spinous process plate
PHQ                Anterior staple as supplemental fixation for fusion
KWQ              Appliance, Fixation, Spinal Intervertebral Body
JDN                 Implant, fixation device, spinal
MQP               Spinal vertebral body replacement device
MNI                Orthosis, spinal pedicle fixation
NKB                Orthosis, spinal pedicle fixation, for degenerative disc disease
MNH               Orthosis, spondylolisthesis spinal fixation
OSH                Pedicle screw spinal system, adolescent idiopathic scoliosis
NQP                Posterior metal/polymer spinal system, fusion
ODP                 Intervertebral fusion device with bone graft, cervical
MAX               Intervertebral fusion device with bone graft, lumbar
PHM               Intervertebral fusion device with bone graft, thoracic
OVE                Intervertebral fusion device with integrated fixation, cervical
OVD                Intervertebral fusion device with integrated fixation, lumbar
LRN                Wire, surgical
MRW              System, facet screw spinal device
PGM                Growing rod system
PGN                Growing rod system, magnetic actuation

This is not the first extension that FDA has granted for UDI compliance.  In August 2014, FDA granted an extension for most contact and intraocular lens labelers.

Registrar Corp helps medical device companies comply with U.S. FDA regulations, including UDI and GUDID.  If you would like assistance with UDI and GUDID requirements, or with determining whether your specific product qualifies for an extension, contact Registrar Corp at +1-757-224-0177 or through the Live Help chat service: http://www.registrarcorp.com/livehelp.





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