On Tuesday, September 24th 2013, the Department of Health and Human Services (HHS) published the following in the Federal Register Volume 78, Number 185, Part V, requiring a Medical Device Unique Device Identification System.
The Food and Drug Administration (FDA) is issuing a final rule to establish a system to adequately identify devices through distribution and use. This rule requires the label of medical devices to include a unique device identifier (UDI), except where the rule provides for an exception or alternative placement. The labeler must submit product information concerning devices to FDA’s Global Unique Device Identification Database (GUDID), unless subject to an exception or alternative. The system established by this rule requires the label and device package of each medical device to include a UDI and requires that each UDI be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI will be required to be directly marked on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use. This rule will go into effect on December 23rd, 2013.
The FDA is expected to release a technical implementation guide that will define the electronic submission message format that will be used to implement this rule. I anticipate that most of the data required by the FDA already exists within applications and systems utilized by medical device companies. Some of the aforementioned systems will probably require some additional data elements such as the UDI, so that an association can be made with each medical device. But I do not anticipate that medical device companies will need to create much “new” data regarding their products. The challenge facing medical device companies will be the creation, maintenance, and validation of submission data in structured product labeling (SPL) format. I anticipate that medical device companies will be best served by making minor modifications to their existing systems to support any new data, and updating their standard operating procedures to remain compliant with the new rule. Additionally, the creation and validation of the actual SPL submission would be most efficiently done by mapping existing data to a proven SPL software product, where the implementation guide technical and regulatory rules can be managed so that validation can happen and the submission generated. This approach will allow medical device companies to quickly implement a solution with minimal impact to existing processes and systems.
In the event a medical device company does not have existing systems containing the required data, or if it would be more effective to adopt a new system to manage and validate this data and allow for submission creation, these companies should evaluate SPL software that provides these full capabilities to ensure the highest level of compliance with the rule as it currently is, and allows for updates as the implementation guide is updated and business rules are modified. These types of updates are inevitable and have been seen in the pharmaceutical product and establishment registration implementation of SPL.
Link to the Federal Register Volume 78, Number 185, Part V: http://www.gpo.gov/fdsys/pkg/FR-2013-09-24/pdf/2013-23059.pdf#!
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