Unique Device Identification (UDI)

Status, Learnings, Next Steps

Jeffrey Shuren, M.D., J.D.Center for Devices and Radiological Health (CDRH)

US Food and Drug Administration (FDA)IMDRF – September 2016

2

What is a UDI?

www.fda.gov

Required on

the device

label,

packages or,

in some

cases, on the

device itself

Code in plain

text and

machine

readable

format (AIDC)

UDI = DI + PI

*+X999123ABC0/$$3140102A1234/S1234/16D20100102J*

3

Benefits of UDI

www.fda.gov

• Collect and analyze more detailed and accurate device information to detect product problems

• Identify and remove unsafe products• Increase likelihood of identifying counterfeit

products

Improve Patient Safety

• Better evaluate product performance• Improve device selection by providers and

patients

More Accurate Understanding of Device Benefit-

Risk Profile

• Understand patient-device characteristics to improve device design

• Inform regulatory decisions (e.g. expand indications, new device approvals, PAS)

Facilitate Device Innovation and Patient Access

4

Establishing a UDI System

www.fda.gov

Develop a standardized system to create the UDI

Place UDI on label and (sometimes) the device

Create and maintain the Global UDI Database

Adoption and Implementation

UDI Final Rule

[78 FR 58786]

Sept 24, 2013

5

Implementation Timeframe

www.fda.gov

Compliance Date Must bear a UDI & submit data to GUDID

September 24, 2014 • Class III devices, incl. class III stand alone software

• Devices licensed under the PHS Act

September 24, 2015 • Implantable, life-supporting and life-sustaining (I/LS/LS) devices, incl. stand alone software

• Direct Marking of I/LS/LS for certain intended uses

September 24, 2016 • Class II devices

• Direct Marking for class III devices and devices licensed under the PHS Act, for certain intended uses

September 24, 2018 • Class I devices and devices not classified class I, II or III

• Direct Marking of class II devices for certain intended uses

September 24, 2020 • Direct Marking of class I devices and devices not classified into class I, II or III, for certain intended uses

6www.fda.gov

Repository of key device identification information

Contains ONLY the DI; PIs are not submitted to nor stored in the GUDID

Contains only PI flags to indicate which PIs are on the device UDI

Data Collection

7www.fda.gov

Public Access to GUDID data

High quality public search, download and web services (APIs)

Provides link to health IT expertise and initiatives

Adoption and Data Use

8

GUDID Records andSubmission Compliance Deadlines

Data Current as of September 1, 2016

Class I & Unclassified

Class II

I/LS/LSClass III

0

100.000

200.000

300.000

400.000

500.000

600.000

700.000

800.000

900.000

9www.fda.gov

0

500

1000

1500

2000

2500

set/

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no

v/1

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jan

/14

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/14

mai

/14

jul/

14

set/

14

no

v/1

4

jan

/15

mar

/15

mai

/15

jul/

15

set/

15

no

v/1

5

jan

/16

mar

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16

Help Desk Cases Opened Help Desk Cases Closed

Helpdesk Statistics

10www.fda.gov

LESSONS LEARNED

September 2013 to 2016

11www.fda.gov

Subject Matter Expert Resources

UDI Team

• Technical

• Regulatory

• Adoption

• Data Quality

• Standards

• UDI Helpdesk

Collaborators

• Internal (Premarket, MDR, Compliance, CBER, CDER, ORA)

• External (device and healthcare industry)

• Government (NLM, ONC, CMS, VA)

• Healthcare Systems

• Registries

12www.fda.gov

UDI Program Components

DataCollection

Education PolicyAdoption

and Data Use

Focus on Data Quality Improvement - Collaborate and Communicate

13

Lessons Learned

• Use data standards; focus on downstream data use

• Set expectation of continuous improvement

• Provide public access to database in multiple forms

• Plan for challenging device types (kits, device systems, consigned devices)

Data Collection

14

Lessons Learned

• Automate help desk tools; consider chat or phone option

• Early and often – website, webinars, guidances, FAQs

• Staff for cyclical ups and downs

• Leverage issuing agencies and other external groups to multiply common messages

Education

15

Lessons Learned

• Leverage available vetted policies/standards• IMDRF UDI Guidance• Issuing Agency Standards• Guidances by other

countries• Establish firm deadlines and

extend as needed• Base policy and technical

decisions on real world use of UDI data

Policy

16

Lessons Learned

• Emphasize value of DI + 5 PI fields –DI is key in database and link across data sources.

• Learning UDI Community framework for shared best practices

• Integrate in National & International device initiatives – NEST, Registries, EHR Certification

• Demonstrate benefit of UDI adoption through pilots, ROI analysis and early adopters

Adoption and

Data Use

17

Labeler Challenges• Setting best practices for adding UDI to label

• Difficult to collect data across Enterprise and submit to GUDID

• Combining regulatory and healthcare uses

UDI is New

• Wide variety of characteristics

• Implantables, instruments, orthopedic trays, software, etc.

• UDI rule can’t cover it all

Heterogeneity of devices

• GUDID fields vary by context of use

• Difficult to coordinate development of consensus-based best practices

• Best source to improve UDI in practice

Variability in UDI use

18

Questions?

FDA UDI Website (including Helpdesk):www.fda.gov/udi

Slide Presentations, Transcripts and Webinar Recordings are available at:

www.fda.gov/CDRHWebinarUnder Heading: Unique Device Identification (UDI) System