Join this webinar to learn: • What SPL is • How it affects medical devices • The relationship between SPL and UDI • What medical device manufacturers can learn from the pharmaceutical industry • How you can automatically create SPL documents with your standard labeling content

1. Ann Rockley, The Rockley Group
Howard Shatz, Data Conversion Laboratory
Demystifying SPL for Medical Devices
January 7, 2015

2. Poll
• How familiar are you with GUDID
requirements?
• With drug and device listings using SPL?

3. Experience the DCL Difference
DCL blends years of conversion experience with cutting-edge technology and
the infrastructure to make the process easy and efficient.
• World-Class Services
• Leading-Edge Technology
• Unparalleled Infrastructure
• US-Based Management
• Complex-Content Expertise
• 24/7 Online Project Tracking
• Automated Quality Control
• Global Capabilities

4. Valuable Content Transformed
• Document Digitization
• XML and HTML Conversion
• eBook Production
• Hosted Solutions
• Big Data Automation
• Conversion Management
• Editorial Services
• Harmonizer

5. We Serve a Very Broad Client Base . . .

6. . . . Spanning All Industries
• Aerospace
• Associations
• Defense
• Distribution
• Education
• Financial
• Government
• Libraries
• Life Sciences
• Manufacturing
• Medical
• Museums
• Periodicals
• Professional
• Publishing
• Reference
• Research
• Societies
• Software
• STM
• Technology
• Telecommunications
• Universities
• Utilities

7. Rockley Life Science and Healthcare Customers

8. About Ann Rockley
Ann Rockley has been helping medical devices, pharmaceutical, and
healthcare providers create intelligent content strategies and adopt
structured content management for more than 15 years. She has
helped clinical, labeling, and marketing content teams to meet the
increasing demands of regulatory requirements, complexities of
globalization, and growing reliance on mobile devices. Known as
the "mother" of content strategy, she introduced the concept with
her best-selling book, "Managing Enterprise Content: A Unified
Content Strategy." Ann has an MIS from the University of Toronto
and is a Fellow of the STC.

9. Howard Shatz is the SPL Project Manager for Data
Conversion Laboratory. Howard has been active in SPL since
its development began in 2003. He is an active member of
the SPL Working Group composed of pharmaceutical
companies and conversion vendors and is a frequent
contributor to the SPL Working Group Wiki discussion forum.
He serves on the Process Communications, Establishment
Registration/Drug Listing, and OTC subteams. He has a BS
in Computer Science from New York University. Prior to
joining DCL, Howard was an account manager at EDS.
About Howard Shatz

10. What is UDI?
• The Unique Device Identification (UDI) came into
effect in 2013 (Final Rule – 78 FR 58786)
• September 24, 2014 all Class III Medical Devices
must bear a UDI with dates on the labels of these
devices formatted as required by § 801.18
• UDI appears on the device and on the product label

11. GUDID
• Global Unique Identifier Database (GUDID)
contains critical information about the device
including:
– Device Information
– Device Status
– Device Characteristics
– Storage and Handling

12. Benefits of UDI
• Identification of the device from distribution
through use
• Ability to tie adverse events to devices and a
specific device
• Can be used in Electronic Health Records

13. GUDID and SPL
• GUDID is part of Health Level 7 Structured Product
Labeling (SPL)
• SPL is an XML Pharma standard schema for the
exchange of product information
• FDA uses SPL for both GUDID and device listings;
GUDID listings are used exclusively for device
information, SPL device listings include some of the
same information as GUDID as well as package images
and content of labeling

14. Structured Product Labeling

15. Accurate Device Product Information
• Proprietary name
• NDC product/item code (if applicable)
• Device Type & Product Classification Code
• Additional Device Identifiers (if applicable)
• Regulatory Identifier
• Device Characteristics
• Drug Information (if label includes drug)

16. Accuracy in Proprietary Name
• Proprietary name is the name of the product
as used in product labeling or in the catalog.
• Special characters, such as the registered or
trademark symbols (® or ™), are not
allowed.

17. Accuracy in NDC product/item code
• NDC product/item is the code assigned using
NHRIC, GS1, or HIBCC code system
• XML tagging identifies the code system
used.

18. Accuracy in Device Type and
Product Code
• Device Type is found in the FDA’s Product Classification Database.
• Database is found at
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/PCDSimpleSea
earch.cfm
• Look up your device and verify that the product code and device name is
is for your device. For example, looking up “piston syringe” produces the
the following hits:
• Injector, Pen (product code NSC)
• Syringe, Antistick (product code MEG)
• Syringe, Piston (product code FMF)
• Syringe, Piston, Reprocessed (product code NKN)

19. Accuracy in Additional Device Identifiers
• Additional Device Identifiers are model number, catalog number,
and reference number.
• No more than one Model Number and one Catalog Number are
• Any number of Reference Numbers (any secondary product
• Model number is the exact model number found on the device label
accompanying packaging.
• Catalog Number is the exact number as it appears in the
manufacturer's catalog, device labeling, or accompanying
packaging.

20. Accuracy in Regulatory Identifier
• Regulatory Identifier identifies the regulatory basis for the submission, both
the general category and the specific identifier. The general category is one
following:
• Premarket Application (PMA)
• Premarket Notification (510(k))
• Exempt Device
• Humanitarian Device Exemption
• For a Premarket Application the specific identifier is a prefix of either “P” or
followed by 6 digits.
• For a Premarket Notification the specific identifier is a prefix of “K” or “BK”
by 6 digits.
• For an Exempt Device the specific identifier consists of 3 letters.
• For a Humanitarian Device Exemption the specific identifier is a prefix of “H”
followed by 6 digits.

21. Accuracy in Device Characteristics
• Device Characteristics that can be identified in an SPL
submission are:
• How many times a product may used (1 for single use)
• Need to be used under sterile conditions (either “true”
or “false”)
• The safety status for MRI (whether it is MRI Safe or MRI
unsafe).
• No other device characteristics can be specified using the
XML tagging for device characteristics.

22. Accurate LOINC Codes for Sections
• LOINC (Logical Observation Identifiers Names and Codes) in SPL identifies specific types
of sections in the content of labeling. A LOINC is specified two ways in a section, once
as a code and once as a standardized value.
• Available LOINCs are found on the FDA’s SPL Resources page
(http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.ht
htm)
• Uses of LOINCs
• Validation - Identify mandatory missing sections, including medication guides.
• Searching - Look for text only in particular section
• Label comparisons – Compare specific sections in labels. For example, one
published study analyzed sections marked as Black Box Warnings and calculated
how many were mismarked.

23. From GUDID to Labeling
• GUDID information tends to be siloed and
only designed to populate the FDA
database
• Yet medical device labeling content also
includes the same information

28. Join us
• Join us Feb 4:
Structuring All Your Labeling Content:
Building on SPL and UDI
• https://attendee.gotowebinar.com/register/
200000000028804894

29. 2nd Annual Content Challenges in Life Sciences and Healthcare Survey
To take this survey, please visit:
http://www.dclab.com/resources/surve
ys/content-challenges-life-sciences-
healthcare-visual-survey-2015
You can view last year’s results at:
http://www.dclab.com/resources/surve
ys/content-challenges-life-sciences-
healthcare-visual-survey-results

30. Useful SPL Links & FDA Contacts
UDI
http://1.usa.gov/1xKF2J5
DCL SPL Page
http://www.dclab.com/spl.asp
FDA SPL Resources
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabe
default.htm
DailyMed
http://dailymed.nlm.nih.gov/dailymed/about.cfm
FDA Online Label Repository
http://labels.fda.gov
Drug Establishments Current Registration Site
http://www.accessdata.fda.gov/scripts/cder/drls/default.cfm
FDA Substance Registration System search page
http://fdasis.nlm.nih.gov/srs/srs.jsp

31. Useful SPL Links & FDA Contacts (cont’d)
CFR Title 21 on-line
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
SPL Working Group Wiki (forums and documentation)
http://spl-work-group.wikispaces.com/
Drug Nomenclature Monographs (links to monographs that define FDA terms,
some terms may not be allowed in SPL)
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissi
onRequirements/ElectronicSubmissions/DataStandardsManualmonograp
hs/ucm071650.htm
Status of OTC Rulemakings
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentR
esources/Over-the-
CounterOTCDrugs/StatusofOTCRulemakings/default.htm

32. Pragmatic Data Validator Lite
http://validator.pragmaticdata.com/validator-lite/
FDA SPL Group
spl@fda.hhs.gov
FDA Drug Registration and Listing System
edrls@fda.hhs.gov
FDA Active Ingredient-Active Moiety Relationship/Basis of Strength (click on the
link, open the zip file, open the spreadsheet)
http://www.fda.gov/Downloads/ForIndustry/DataStandards/StructuredPr
oductLabeling/ucm350983.zip
FDA OTC Monograph - Active Ingredient (click on the link, open the zip file, open
the spreadsheet)
http://www.fda.gov/Downloads/ForIndustry/DataStandards/StructuredPr
oductLabeling/ucm352012.zip
Useful SPL Links & FDA Contacts (cont’d)

33. Poll
• Are you planning to include device information in
drug listings?

34. Q&A
Howard Shatz
SPL Project Manager,
Data Conversion Laboratory
(718) 307-5719
hshatz@dclab.com
@dclaboratory
Ann Rockley
CEO,
The Rockley Group
(905) 939-9298
rockley@rockleygroup.com
@arockley