Unique Device Identification (UDI) Requirements for Medical Device
For medical device manufacturers, this new UDI (Unique Device Identification) regulation requires compliance beginning as early as September 24, 2014. That’s a short amount of time to not only gather the 62 points of data required for each unique device, but to submit them in the correct format to the FDA’s new Global Unique Device Identifier Database (GUDID) for each and every unique product, product version, and product configuration. Although the regulation will first be enforced for Class III Medical Devices, Class II and Class I devices will follow suit in the coming years.
This requirement will look to reduce or eliminate the underreporting of adverse events and the failure to communicate critical information like product recalls to doctors and hospitals.
Unique Device Identification (UDI) will require each medical device to have a unique 14 digit ID number. It will also require Key Product Data be registered in FDA’s new Global Unique Device Identifier Database (GUDID). Anytime a medical device changes or a new product version, variant or packaging configuration is developed, a new UDI submission must be made.
Collecting, submitting, transforming and tracking the vast amounts of product data required to meet the new regulations will be taxing on the infrastructure, personnel, time and resources of medical device firms.
With enforcement beginning for Class 3 Medical Devices in 2014, compliance is not an option for companies who wish to remain eligible to sell in the US.
For the past 2 years, PTC has worked with the FDA and Major Medical Device Manufacturers to develop the PTC UDI Solution. PTC UDI is a pre-configured, out of the box solution to help accelerate UDI compliance.
- Collects and Controls UDI submission data from the many locations it may be stored across the organization.
- Automates Key Processes including the Review and approval of UDI submissions and the transformation of UDI data into the format required for electronic communication to the FDA and the tracking and reporting of submission status.
- Streamlines the management of UDI Data, accommodating product changes and scaling to meet future global UDI regulations.
In short, the PTC UDI solution helps Medical Device Manufacturers manage the UDI process from end to end and achieve UDI compliance without complexity.
The Unique Device Identification (UDI) module in PTC Windchill 10.2 has the following benefits:
- Implementing a standard process for efficiently complying with the FDA Part 830 regulation on UDI submissions to the FDA GUDID
- Automating the creation, editing, review, electronic submission, change management, and monitoring of those submissions
The UDI module has the following capabilities:
- Data collection and initiation accelerators
- Pre-configured process for editing, review, and change management of UDI for all products
- Predefined but configurable workflows, screens, and reports
- Automatic HL7 generation and electronic submission to the FDA Electronic Submissions Gateway (ESG)
- Ability to deploy alone or integrated with PLM
- Robust reporting and submission monitoring
The UDI module delivers the following values:
- Dramatic effort reduction for UDI data collection and submission
- Centralized UDI submission management
- Historical management of UDI for follow-up submissions
- 21 CFR Part 11 Complaint
- Highly secure with role-based interaction
- High throughput based on a global enterprise platform
UDIs can easily be brought into Windchill in two ways:
- Created in Windchill
- Imported from a spreadsheet
Created or imported UDIs can be independent submissions, or they can be associated with a Windchill part. Creating the UDI from a part allows the system to pre-populate information associated with the part, so users enter less information manually. Users can also create UDI templates to facilitate information entry.
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