Medical device companies are affected by the Unique Device Identification ruling from FDA. UDI experts Reed Tech help members of the Medical Devices Group understand the complexities.
You can find the audio replay and transcript at http://medgroup.biz/unique-device-identification
9. UDI Implementation Timeline
Key FDA Documents
2013-09-24
2013-11-21
2014-02-13
TBD
UDI Final Rule and
Draft GUDID Guidance for Industry (database definition)
Draft GUDID SPL Implementation Specification (SPL XML message definition)
Revised Draft GUDID SPL Implementation Spec (folder name, FDA PT Code)
Final GUDID GFI and Final GUDID SPL Implementation Spec
Reference: FDA UDI website
www.ReedTech.com
9
10. UDI Regulation Overview
Labeling
UDI (Device Id + Production Id) on Device Label & Pkg
UDI in plain-text (human readable) and
Automatic Id and Data Capture (AIDC) technology
• 1D/2D barcode, RFID, near-field communication…
• If AIDC is not visible, add disclosure
Date Format YYYY-MM-DD (2013-10-29)
UDI on “Device” Software
Direct Marking (DM)
Multiple use and reprocessed devices
Permanently mark UDI on device
FDA Global UDI Database (GUDID)
Submit DI and device attributes
Public access, global model
GUDID
Reporting – include UDI as available
www.ReedTech.com
10
16. Results of Attendees Survey
How far along are you in identifying,
collecting and organizing the UDI data that
you will need to submit to the FDA?
(407 responses)
If you are submitting Class III UDI data to
the FDA, and taking into consideration the
September 24, 2014 deadline, when are you
anticipating making your submissions?
(369 responses)
Have you decided what method you will use
to submit your UDI data to the GUDID?
(474 responses)
If yes, which of the following methods do
you prefer? (286 responses)
www.ReedTech.com
16
18. GUDID Data Submission Methods Comparison
Submission
Method
Description/Comments
FDA GUDID
Web
Interface
• You (or third party) enter data
directly into the FDA GUDID
• Best suited for low volume
• Transcription error concern
• “No” software cost
• Admin, data entry,
& QA labor (yours
or third party)
• Use external software to collect
data, build, and submit SPLs to
FDA via the ESG
• High volume, electronic submissions
• “Rent” software
• Admin &
operations labor
• “No” Admin &
operations labor
• Service cost
Hosted
Software
(Software as
a Service)
Technology Cost
Operations Cost
Outsourced
Service
• External provider accepts your data,
builds, and submits SPLs to FDA via
the ESG on your behalf
• “No” software cost
Internal
Software
• Buy / build / upgrade software (ERP,
PLM, MDM, Labeling or other) to
collect data and build SPLs
• Submit SPLs to FDA via the ESG
(AS2)
• “Own” software
(buy/build/upgrade,
• Admin &
install, validate,
operations labor
train, maintain)
• ESG account (AS2)
www.ReedTech.com
18
29. GUDID Data Submission Plans
1. Evaluate your “data situation” (location, gaps, owners, formats, etc.)
2. Determine your best GUDID data submission method/tool
3. Collect, Normalize, and Validate source GUDID data
• Collect data from multiple sources; generate values as required
• If necessary, capture data from Label (e.g., single use icon)
• If desired, collect additional data fields for future UDI submissions to
•
•
international Regulatory Authorities and/or your internal purposes
Merge partial records from multiple “data sources”
“Normalize” data to FDA GUDID specs (e.g., Business Rules, Controlled Vocabularies)
4. Create FDA GUDID Account
5. Submit Data
• For Manual, Individual Record Entry: enter data via FDA GUDID Web Interface
• For Automated, Bulk Entry:
Create fully‐valid SPL UDI submissions per FDA business rules
Submit SPL UDIs to FDA via ESG (WebTrader, AS2)
6. Submit changes/revisions and new device records
www.ReedTech.com
29