Enhancing patient safety begins with global visibility for every medical device on the market. In this blog you will learn how the U.S. Food and Drug Administration (FDA) has implemented a system for obtaining specific medical device product data within a central portal for both the private and public sectors.
Where can hospitals, clinicians, patients, researchers and interested stakeholders access information about a particular medical device? The Global Unique Device Identification Database (GUDID), administered by the FDA, serves as this database by providing a comprehensive reference catalog for each medical device with a Unique Device Identifier (UDI).
The database only includes information important to the identification of devices and does not include any information identifying a patient. All 64 data elements required by 21 CFR 830.310 (directing electronic records to be maintained or submitted to the FDA) are included.
Some of the key benefits is the ability to facilitate quick and accurate medical device identification, removing potential confusion about device use. High standards for accurate data to be submitted and ensuring product accuracy for downstream users is also another crucial benefit. Top-tier device manufacturers are pairing the UDI together with the digital thread for end-to-end traceability of their data.
The FDA established the UDI system in 2013, requiring medical devices to include a device label in a machine and human-readable format. Within the UDI system, GUDID was created as a foundational database used to store medical device product information associated with the UDI. The database officially launched in December 2013, with the public access portal, AccessGUDID, available in May 2015.
Data submission requirements have been deciphered by the medical device risk class, with various deadlines for compliance. Class I medical devices were originally required to be submitted to the GUDID by September 24, 2020, however, unforeseen supply chain shortages from the pandemic delayed this submission requirement to September 24, 2022. See the timeline, below.
Mandated by the FDA, medical device labelers are required to submit data records for medical devices marketed in the United States to the GUDID. The FDA Final Rule provides a thorough definition of a labeler. As defined, the labeler is the entity that applies or modifies the label and brings the device to market under its brand. Typically, this consists of the medical device manufacturer, however it may also be the specification developer, device distributor, reprocessor, repackager or relabeler. The regulatory or compliance team of a medical device company is usually responsible for determining if they constitute as the labeler, per FDA’s definition.
If more than one entity is involved in bringing a medical device product to the market, the labeler responsible for submitting product data must define this joint venture in a written agreement. Duplicate submissions should be avoided and failure to submit product data altogether may result in both entities being held accountable to the FDA.
A total of 64 data elements are required for submission, with 57 submitted by the labeler and 7 populated by the FDA. The FDA has provided a spreadsheet of data requirements. Note, only the Device Identifier (DI) portion of a UDI code is submitted to the GUDID, per FDA guidance.
The required specifications for GUDID submission embody all of the device information available in the UDI, including a detailed device description and version/model, Issuing Agency, labeler company’s name, address and DUNS code. Additional information is also required per submission, including some of the following:
Commercial distribution – Determines when a record would be publicly available on AccessGUDID, whether the device is in commercial distribution, and when the device is no longer offered for commercial distribution by the labeler on record.
Alternative or additional identifiers – Indicates if the device is exempt from Direct Marking (DM) requirements under 21 CFR 801.45, if the DM DI Number is different than the Primary DI Number and what the secondary DI, previous DI, or package DI is.
Customer contact – Phone and email address of a customer service contact is required so patients and consumers can ask any device-related questions.
Premarket – Determines if the device is exempt from premarket submission or the FDA premarket submission number.
FDA product code and listing – Both the FDA product code (a categorization for devices) and Product Code Name (associated with the three-letter Product Code) are required in addition to the listing number, which is assigned by FDA during registration and listing of all devices in commercial distribution, regardless of pre-market authorization requirements.
Storage, handling and sterilization – Identifies device storage and handling requirements (such as temperature) and sterilization specifications including, packaged as sterile or requires sterilization prior to use.
A critical prerequisite step for submitting device data to the FDA begins with establishing a GUDID account. To do so you will need to decide how many GUDID accounts are needed. Each account is tied to a separate Labeler Organization, such as corporate headquarters. How large is the organizational structure? If it is small to medium-sized, usually only one account is necessary. What about larger companies? Bigger companies may request a single account for all products OR create multiple accounts for differing portfolio segments.
Both Labeler Organizations and Labelers must be sourced in the account application with their Dun & Bradstreet DUNS number. Note, while application for a DUNS number is free, the process may take up to 30 business days.
Organizations must determine how they want to submit data through one of two methods: manual data entry or Health Level 7 (HL7) Structured Product Labeling (SPL). Some considerations include:
Does the company have a small number of records to submit? If so, they may want to enter data into the database manually through the free web interface, although the cost of staff time and expertise needed to enter and validate data should be considered regardless of device amount.
Does the company have a high volume of submissions? If so, they will likely need to submit data in an SPL format, requiring data conversion for submission-ready SPL files (through the FDA Electronic Submissions Gateway (ESG)). In this case, companies can purchase/build software or work with third-party providers, such as Reed Tech, for expertise in both validating and submitting data.
|GUDID Web Application Overview
|HL7 SPL File Submission Overview
Ideal method for fewer records needed for GUDID submission
Ideal method for several records needed for GUDID submission
Requires manual data entry
Allows bulk submission and requires technical knowledge
Once companies determine their submission method, they must identify GUDID account personnel and request a GUDID account from the FDA. If they want to submit data in an SPL format, the SPL submissions need to be tested (in a separate test account provided by FDA) to ensure submissions flowing through the ESG are successfully imported.
Class I and unclassified medical devices required to be labeled with a UDI code must submit product data to the FDA GUDID by September 24, 2022. Medical device companies must first determine if their products are affected by this deadline. Do any of the following conditions apply to you?
Note there is a Class I GUDID Submission Exception for certain Class I devices that are 510(k) exempt and only sold over the counter to consumers.
Some examples for product types requiring UDI in a professional use, such as a hospital, include hospital beds, stethoscopes, dental instruments and equipment (chairs). Certain consumer use products (such as sunglasses, pill crushers, electronic toothbrushes) require UDI but not GUDID submission. Products sold in both professional settings and over the counter require UDI and include items such as band aids, first aid kids, and dental floss.
Upon determining if a product falls within the Class I submission regulation, FDA compliance for Class I devices includes:
Labeling – The UDI must be on the device product and package labels in a human-readable plain-text and Automatic Id and Data Capture (AIDC) technology, with the date format listing in YYYY-MM-DD (except AIDC date must use Issuing Agency date format)
Direct marking – Multiple use or reprocessed devices must have the UDI permanently marked
Submission to GUIDID – DI & device attributes (57 total) must be submitted to GUDID (through public portal, AccessGUDID)
Reporting and retention – UDI must be included in Annual Reports, DHR, complaints, MDR, recalls, service, tracking, post market surveillance, in addition to electronic record compliance (as part of 21 CFR 11) and a 3-year record retention (even after device is off of the market)
A common question I hear from our customers, especially those with Class I medical device products, is “where do we begin?” Here is an implementation summary for you to reference as the Class I submission deadline quickly approaches:
UDI process prep – Determine who in your organization is responsible for UDI submissions and create a UDI governance team. Also identify FDA UDI requirements for your products, evaluate your situation and prepare the UDI environment.
Data prep – Understand what data elements are required, collect source GUDID data as well as normalize and validate data. If needed, you can work with a vendor, such as Reed Tech, to help with this step.
GUDID system and submission – Evaluate, select, and implement a GUDID solution, create FDA GUDID & ESG accounts, submit GUDID data to FDA and verify GUDID submission and publication.
Labeling system – Prepare labeling environment and test labels.
UDI operation – Start production and maintain data and systems, in addition to preparing for international UDI requirements for various health authorities around the globe.
Your team may know by now how complex and time-consuming reporting accurate data to the GUDID is, in addition to the regulatory burden of meeting impending compliance dates. Reed Tech expertise and solutions can substantially help you in quickly, affordably, and effectively complying with regulatory product data submission requirements. Even if you have 25 or fewer Class I medical devices, Reed Tech provides a targeted solution for UDI data reporting. Contact us today at MedDevice@ReedTech.com or +1-215-557-3010.
Gary Saner, Sr. Manager, Information Solutions Life Sciences, Reed Tech.
Gary is a subject matter expert on medical device unique device identification and other structured content reporting to regulatory agencies and commercial organizations. He has over 30 years of experience in software development, process management and data administration with the last 15 years focused on the life sciences industry. He serves as co-chair of the industry’s Structured Product Labeling Technical Team and on the advisory board of the Medical Devices Group.