Posted 20 November 2014
By Alexander Gaffney, RAC
The US Food and Drug Administration (FDA) is granting labelers of certain types of implantable medical devices a temporary reprieve from its upcoming requirements that all medical device products be marked with a unique device identifier (UDI) meant to make the devices safer.
A UDI is, as its name implies, a system of identifying each medical device using a specific system.
The system has a number of allures for regulators. "The unique device identification system will help reduce medical errors, and will allow FDA, the healthcare community, and industry to more rapidly review and assess adverse event reports, identify problems relating to a particular device, and thereby allow for more rapid and effective corrective actions that focus sharply on the specific devices that are of concern," FDA wrote in 2012.
At its core, the rule calls for devices to be marked with a UDI system composed of two parts: a device identifier that corresponds with the type of device and its manufacturer, and a production identifier that states its lot, batch, serial number, expiration date, date of manufacture and other relevant information.
The rule was originally mandated by the Food and Drug Administration Amendments Act (FDAAA) of 2007, but was subject to lengthy delays, both due to extensive rewrites resulting from industry criticism and months of review by the Office of Management and Budget (OMB).
FDA's UDI rule, released in September 2013, calls for different classes and types of devices to be subject to UDI marking requirements at different times.
For example, some Class III (high-risk) medical devices had to adhere to the UDI rule's direct marking requirements within 90 days, or by the end of 2013. All other Class III devices had until September 2014 to comply.
Low-risk (Class I) and moderate-risk (Class II) devices were, on the other hand, generally given much more time to comply with the act's requirements. Class II devices have until September 2016 to comply, while Class I devices have until September 2018 to do the same. (See "Effective Dates" in the UDI Rule.)
With the UDI rule affecting nearly every medical device regulated by FDA, the agency has had to delay its implementation on at least a few products.
Under 21 CFR 801.55(d), FDA is allowed to "initiate and grant an exception or alternative if we determine that the exception or alternative is in the best interest of the public health."
To date, FDA has granted at least one narrow labeling exception for manufacturers of Class III contact lens and intraocular lens labelers. Those companies have until September 2015 to label their products in accordance with the UDI rule's direct marking requirements.
A New Delay
Now FDA has quietly announced yet another labeling exemption, this time for a much larger group of products.
In a 19 November 2014 letter posted on its website, FDA said some implant labelers will have until 24 September 2016 to comply with the marking requirements of the UDI rule.
The exemption is intended to allow labelers of single-use implants intended to be sterilized before use to comply with the rule, FDA said.
As FDA explains in its letter, the original intent of the UDI rule was to require direct marking of identifiers on the device. That requirement was later scrapped, in part because of the potential for those markings to affect the safety and efficacy of a device. Instead, FDA allowed some products to have UDI markings on the product's packaging under the theory that the packaging would accompany the device up until the point of implantation.
However, for single-use devices intended to be sterilized prior to use, this isn't necessarily the case, as the sterilization process takes place separately and apart from the implantation process, generally leading to the packaging being discarded.
After the trade group AdvaMed complained to FDA that industry needed more time to implement solutions meant to adequately identify devices separated from their original label and packaging, FDA said it decided to delay the implementation of the rule's marking effects for certain devices.
Affected device types include the following:
|Implant, endosseous, root-form, abutment |
|Implant, endosseous, orthodontic |
|Lock, wire, and ligature, intraoral |
|External mandibular fixator and/or distractor |
|Plate, bone |
|Prosthesis, condyle, mandibular, temporary|
|Screw, fixation, intraosseous|
|Mesh, surgical, metal|
|Cover, burr hole |
|Plate, cranioplasty, preformed, alterable |
|Plate, cranioplasty, preformed, non-alterable |
|Fastener, plate, cranioplasty |
|Shunt, central nervous system and components|
|Bone fixation cerclage, sublaminar|
|Cerclage, fixation |
|Rod, fixation, intramedullary and accessories|
|Appliance, fixation, nail/blade/plate combination, multiple component|
|Appliance, fixation, nail/blade/plate combination, multiple component, metal composite|
|Appliance, fixation, nail/blade/plate combination, single component|
|Condylar plate fixation implant|
|Device, fixation, proximal femoral, implant|
|Nail, fixation, bone|
|Plate, Fixation, Bone|
|Staple, fixation, bone|
|Washer, bolt nut|
|Component, traction, invasive|
|Fastener, fixation, nondegradable, soft tissue MBI |
|Pin, fixation, smooth|
|Pin, fixation, threaded|
|Sacroiliac joint fixation|
|Screw, Fixation, Bone|
|Accessories, Fixation, Spinal Interlamina|
|Appliance, fixation, spinal interlaminal|
|Orthosis, spine, plate, laminoplasty, metal|
|Spinous process plate|
|Anterior staple as supplemental fixation for fusion|
|Appliance, Fixation, Spinal Intervertebral Body|
|Implant, fixation device, spinal|
|Spinal vertebral body replacement device|
|Orthosis, spinal pedicle fixation|
|Orthosis, spinal pedicle fixation, for degenerative disc disease|
|Orthosis, spondylolisthesis spinal fixation|
|Pedicle screw spinal system, adolescent idiopathic scoliosis|
|Posterior metal/polymer spinal system, fusion|
|Intervertebral fusion device with bone graft, cervical|
|Intervertebral fusion device with bone graft, lumbar|
|Intervertebral fusion device with bone graft, thoracic |
|Intervertebral fusion device with integrated fixation, cervical |
|Intervertebral fusion device with integrated fixation, lumbar|
|System, facet screw spinal device|
|Growing rod system|
|Growing rod system, magnetic actuation|