Many medical device companies are currently in the process of collecting the Unique Device Identification (UDI) information needed for submission to the FDA’s Global Unique Device Identification Database (GUDID). These companies are likely to be gathering that data from numerous different departments and business units, while some may even have to gather information that has previously been managed entirely by subsidiaries or even other companies.
Aggregating this enormous collection of information into a single, GUDID-compliant data stream suitable for electronic submission to the FDA can be a complicated task. It is not a question of whether errors will occur, but rather what safeguards and procedures are in place to detect and remediate these errors. Some will be human errors introduced during transcription or data entry, but others will be introduced during data migration and importation procedures, each of which is likely to be assisted (if not controlled) by automated processes.
A well-designed GUDID solution will be able to identify any irregularities or outright errors in the data, regardless of how they were introduced, and flag them for human review.
As the system imports the mixed data from an organization’s various repositories into a comprehensive file, errors identified by your GUDID solution during the migration process can be pulled into a separate report for manual validation.
Sometimes data itself will be malformed. For example, a DUNS number, one of the basic identifying fields in any GUDID entry, is always nine digits in length. An eight-digit number in a DUNS field, then, is obviously incorrect. The GUDID solution should flag the record and ensure that it receives closer examination.
The Three Stages of a GUDID Record
Despite all the precautions taken with data validation, it is still possible (and, in the case of particularly large GUDID datasets, perhaps probable) that some errors will get through.
Most of the data fields submitted to the FDA will be permanent after a short grace period. Some of the fields in a GUDID entry, however, will remain modifiable by the submitting company for as long as the entry exists, or at least for as long as the product it documents is available in the marketplace, as in some of the examples below.
Entries in the GUDID exist in one of three states:
1) Draft GUDID record
A draft record is essentially a “scratch” record with no regulatory requirements. It can be edited an unlimited number of times and is not available for public search and retrieval.
The FDA’s GUDID Web Interface offers the option to create “Draft” Device Identifier (DI) records, and is useful for submitters who want to familiarize themselves with the process for creation and saving DI records in the GUDID. Note that the Draft option is only selectable in the FDA GUDID Web Interface option; HL7 SPL records cannot be submitted with a Draft status – they will be rejected.
2) Unpublished GUDID record
This state is the precursor to the final, Published state for a record in the GUDID and is effectively a step in the progression to the Published state, depending upon its scheduled publish date (which is, itself, a GUDID attribute).
Though not yet available for public retrieval, an Unpublished record has passed all business rules and is presumed to be under the regulatory umbrella. Consequently, though an Unpublished record remains fully editable, any changes to it require it to go through business rules validation again.
An Unpublished record can be used as a template for other entries, shortening data entry time. Again, this is typically relevant only for smaller manufacturers that are using the FDA GUDID Web Interface.
3) Published GUDID record
Once a record enters the Published state, it has permanently left your company’s control in one important respect: it can now be changed back to the Unpublished state only by the FDA.
Each individual entry has its own seven-calendar-day grace period—not to be confused with the overall GUDID grace period during the database’s phased rollout—during which you will retain the ability to modify any of its fields, with the notable exception of the publish date itself. Once the seven-calendar-day grace period expires, most attributes of the published record in the GUDID are frozen.
Correcting Errors in a Record
If an error is discovered after a record enters an Unpublished or Published state, the approach to making a correction varies depending on the state of the record. An Unpublished record’s fields can all be changed, assuming this is the initial submission. If a record reaches the Published state, more conditions apply.
During the grace period, all fields in a Published record can be edited, except for the Publication Date. After the grace period, certain fields can still be edited (e.g., Catalog Number), while others are locked (e.g., Primary Device Identifier).
Two options exist if an error is found in a fixed field or after the grace period. First, the record can be retired and a new record submitted. Second, a Help Desk ticket may be submitted to the FDA, requesting assistance in correcting the error. Depending on the reason for the change, the FDA may be receptive to a request to move the record back to an Unpublished state. However, if the request is denied, the only remaining option is to retire the record and submit a new one in its place.
The rules surrounding error correction of GUDID records are complex and retiring a record has significant consequences to a labeler’s other business areas. This makes proper planning and selection of a GUDID solution crucial for the medical device labeler. The Reed Tech subject matter experts can help. Contact Haley Lentz for assistance in getting it right the first time and managing your UDI data in a way that relieves the pain of GUDID submissions: +1-215-441-6438, HLentz@ReedTech.com