http://MedicalDevicesGroup.net Reed Technology, in collaboration with the Medical Devices Group, present information regarding the FDA's Unique Device Identifier (UDI) and discuss strategies to implement your UDI submissions solution.
10. UDI Implementation Timeline
Key FDA Actions
2013-09-24 FDA released UDI Final Rule and
Draft GUDID Guidance for Industry (database definition)
2013-11-?? Awaiting GUDID SPL Implementation Specification (SPL XML message definition).
Delay is due to federal government shutdown.
2013-11-25 Comment period for Draft GUDID Guidance for Industry will end. Final GFI TBD.
Reference: FDA UDI website
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11. 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 Part Marking (DPM)
Permanently mark UDI on device itself
Multiple use and reprocessed devices
FDA Global UDI Database (GUDID) (“Good-I-D”)
Submit DI and device metadata
Public access, global model
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GUDID
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15. Results of Attendees Survey
Q1 - Estimate the total number of product
SKUs you need to submit to the FDA for all
classes. (309 responses)
Uncertain or Not Applicable
> 100,000
50,001 – 100,000
10,001 – 50,000
1,001 – 10,000
101 – 1,000
< 100
Q3 - How far along are you in identifying,
collecting and organizing the UDI data that
you will need to submit to the FDA? (309
responses)
28%
2%
Uncertain or Not Applicable
2%
Identification, etc. completed
3%
3%
Identification, etc. underway
12%
9%
Planning started
11%
20%
40%
26%
Not started
41%
0%
26%
60%
37%
0%
20%
40%
Q2 - What device classes does your
organization manufacture (select all that
apply)? (474 responses)
Q4 - What method would you prefer to use
to submit your UDI data to the FDA? (307
responses)
Uncertain or Not Applicable
Class I
Class II
Class III
Uncertain or Not Applicable
Use the FDA GUDID web tool
Use a service provider
Use purchased software
Use internally developed tool
21%
40%
64%
29%
0%
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20%
40%
60%
80%
65%
14%
4%
4%
12%
0%
15
20%
40%
60%
80%
17. 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
• 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. For Manual Entry: enter data via FDA GUDID Tool
5. For Automated Entry:
• Create fully‐valid SPL UDI submissions per FDA business rules
• Submit SPL UDIs to FDA via ESG (AS2)
6. Submit changes/revisions
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19. GUDID Data Submission Options
Submission
Method
Description/Comments
FDA GUDID
Tool
• You (or third party) enter data
directly into the FDA GUDID
• Transcription error concern
• Low volume
Outsourced
Service
• External provider accepts your data,
builds and submits SPLs to FDA via
the ESG on your behalf
Technology Cost
• “No” tool cost
SaaS
• Use external tool to collect data,
(Software as
build and submit SPLs to FDA via
a Service)
the ESG
UDI
Software
Utility
Operations Cost
• Admin, data entry
& QA labor (yours
or third party)
• “No” tool cost
• “No” Admin &
operations labor
• Service cost
• “Rent” tool
• Admin &
operations labor
• Buy / build / upgrade an internal tool • “Own” tool
(buy/build/upgrade,
(ERP, PLM, MDM, Labeling or other)
• Admin &
install, validate,
to collect data and build SPLs
operations labor
train, maintain)
• Submit SPLs to FDA via the ESG
• ESG account (AS2)
(AS2)
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25. Appendix – Additional Final Rule Highlights
Label
• UDI (DI+PI) required on label and package in plain text and AIDC format
• If AIDC is not visible, use disclosure (not the proposed AIDC symbol)
• If Mfr/Expiration dates are displayed, use YYYY‐MM‐DD format and include dates in PI
Direct Part Marking: permanent UDI required, if multi‐use & reprocessed (not implants)
GMDN GUDID terms: freely available from FDA
All NHRICs and NDCs assigned to devices: rescinded by 2018‐09‐24, able to request use of
legacy labeler code
Broad Exceptions: research (non clinical), investigational, vet device, exports, national stockpile
Stand‐alone Software: UDI required, downloads exempt from AIDC
Class I GMP Exception: UDI not required
Class I Exception: No PI required
Class I Retail Exception: UPC can be UDI
…
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