Kallik minimizes the impact of staying compliant with current and forthcoming medical device regulations
What is FDA UDI?
The purpose of this regulation was to encompass various FDA concepts to provide safe and effective products to the public. A Unique Device Identifier (UDI) needs to be included on device packaging and labelling with device attributes being submitted to a new database (GUDID) facilitating device and manufacturer traceability. Following its success, similar initiatives are now rolling out globally, most notably the new EU MDRs.
How does Kallik help with UDI?
Kallik helps medical device manufacturers ensure their products are correctly labelled in accordance with UDI requirements including human and machine-readable device and production identifiers along with the correct formatting of manufacturing and expiration dates. With the September 2020 deadline looming for Class I compliance affecting thousands of products, organizations need to make the transition to a global labeling solution if not already done so.
- Minimizes the impact of creating UDI compliant labelling by optimizing available label real estate
- Establishes a single source of labelling ‘truth’ that all market-facing product information and materials flow from
- Ensures alignment and traceability of content reducing risk of errors and discrepancies for device manufactures choosing to publish IFUs electronically (eIFUs) as well as in print form
Timeline of Updates
September 2013: UDI Final Rule published
The Food and Drug Administration (FDA) issues a final rule (21 CFR 801.45) to establish a system to identify devices throughout distribution and use that requires the label and packaging of the device to include a unique device identifier (UDI) both in plain text and machine-readable format. Device Identifiers are to be submitted to a public database (GUDID) to enable the healthcare community and the public to obtain critical information on the medical devices they use.
September 2014: Labeling of Class III Devices
The date from which devices classified as ‘high risk’ devices such as deep brain stimulators, life supporting and life sustaining products were required to carry a UDI both in plain text and machine readable formats (e.g. 1D or 2D barcode) on the label with the corresponding Device Identifier submitted to the GUDID. Direct marking of Class III devices was required from September 2016.
September 2016: Labeling of Class II Devices
The date from which devices classified as ‘intermediate risk’ devices such as CT scanners or infusion pumps for intravenous medicines were required to carry a UDI both in plain text and machine readable formats (e.g. 1D or 2D barcode) on the label with the corresponding Device Identifier submitted to the GUDID. Direct marking of Class II devices was required from September 2016.
September 2020: Labeling of Class I Devices
The date from which devices classified as ‘low risk’ products such as oxygen masks, bandages and stethoscopes are required to carry a UDI both in plain text and machine-readable formats (e.g. 1D or 2D barcode) on the label with the corresponding Device Identifier submitted to the GUDID. The FDA has delayed the requirement for direct marking of Class I devices to September 2022.
How to be compliant
Establish a global source of labeling truth backed up by digital signatures and comprehensive audit trails that all market-facing product information and materials flow from to deliver process transparency and simplify proof of compliance.
Eliminate multiple siloed systems by moving to a centralized cloud-based solution will improve visibility, control and co-ordination making it easier to identify and updated impacted labels whilst demonstrating compliance
Implementing a labeling solution already proven to meet FDA and EU requirements will reduce the burden of compliance with the increasing number of regional regulatory authorities around the world in the process of implementing UDI for medical devices.
Unite dispersed teams and eliminate disjointed processes resulting from use of spreadsheets, documents, emails and localized desktop solutions that otherwise make identification of all impacted labels an almost impossible task.
Be prepared for further global roll-out of UDI and the anticipated need for product serialization by using best practices for UDI compliance as an opportunity to get ahead of the market by transforming your labeling processes now.
Ensure information conveyed in both human and machine-readable Device and Production Identifiers on product and package labeling is accurate and aligned with submissions to the GUDID