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CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING www.freyrinc.com CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING FREYR UDI VISION SERIES PART 1 - UDI READINESS Date: 14 Nov 2014

FREYR UDI VISION SERIES SESSION 1 - UDI READINESS

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Page 1: FREYR UDI VISION SERIES SESSION 1 - UDI READINESS

1 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING www.freyrinc.com CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING

FREYR UDI VISION SERIES PART 1 - UDI READINESS

Date: 14 Nov 2014

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Agenda

1. Overview - UDI

2. GUDID Components

3. UDI – Master Data Management

4. Freyr Leverage – UDI Compliance Expertise

5. Freyr IDENTITY – UDI Software Solution

6. Freyr Corporate Overview

7. Q&A

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OVERVIEW UNIQUE DEVICE IDENTIFICATION

Presenter : Alan

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FDA UDI Rule Summary The Food and Drug Administration (FDA) has released a final rule (September, 2013) requiring that most medical devices distributed in the United States carry a unique device identifier, or UDI.

The UDI ruling implementation timelines are based on the product classification emphasizing on risks. Class III devices will be first to comply, then Class II, and concluding with Class I.

As part of the UDI system, FDA has created a Global Unique Device Identification Database (GUDID) which will include a standard set of basic identifying elements for each device with a UDI.

The GUDID is made available to the public and serves as a centralized repository for easy device information look up.

What is UDI A UDI consists of two parts; Device Identifier (DI) + Production Identifier (PI), i.e. UDI = DI+PI. A DI is mandatory, fixed portion of a UDI that identifies the device information. PI is a conditional, variable portion of a UDI that identifies specific attributes of a device when included on the label. UDIs are issued by an FDA accredited issuing agency that operates a system for assignment of UDIs according to the final rule.

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Impact to the Medical Device Industry CHALLENGES BENEFITS

Collection, Conversion and Submission of UDI data to GUDID.

Timely review and approval of all UDI data through auditing internal processes.

Create new submissions for all product versions and variants.

Update submissions for changed products.

Track FDA responses, including approvals, rejections, product recalls, etc.

Developing recordkeeping and reporting policies and procedures.

Comply with similar global UDI regulations coming soon from various regional markets.

Effective medical device recalls.

Enhanced patient safety.

Adequate tracking and tracing.

Accurate reporting of adverse event reports.

More transparency in supply chain and inventory management.

Improved post-market surveillance.

Single source of information for public and health professionals.

Device documentation for use in EHRs, clinical information

systems, and registries, etc. Enhanced business processes.

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Issuing Agencies

Under the GS1, the Global Trade Item Number™ (GTIN™) is used for the unique identification of trade items worldwide. A device identifier with GS1 as issuing agency shall be greater than 12 digits or equal to 14 digits in length; DIs with less than 14 digits should be appended with leading zeros. Brand Owners or manufacturers must allocate and maintain their GTINs according to the rules of the FDA UDI mandate and the GS1 Standard.

A device identifier with ICCBBA as issuing agency shall be alphanumeric; 10 or 16 characters in length. ISBT 128 is the global standard for the terminology, identification, labeling, and information transfer of medical products of human origin (including blood, cell, tissue, and organ products) across international borders and disparate health care systems.

HIBCC codes are alphanumeric and up to 6-23 characters in length.. Labeler identification Code (LIC) is assigned by HIBCC. Identifies the labeler. It is four alphanumeric characters.

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Timelines in Detail

Sept 24, 2014 Class III devices, including class III stand alone software Devices licensed under the PHS Act

Implantable, life-supporting and life-sustaining (I/LS/LS) devices, including stand alone software

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

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

Class I devices and devices not classified class I, II or III Direct Marking of class II devices for certain intended

uses Sept 24, 2015

Sept 24, 2016

Sept 24, 2018

Sept 24, 2020 Direct Marking of class I devices and devices not

classified into class I, II or III, for certain intended uses

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GUDID COMPONENTS

Presenter : Prasanna

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GUDID Components Centralized repository of key device identification information. Contains only the DI information; PI information is not submitted or stored in the GUDID. Contains only PI Yes/No flags to indicate which PI attribute(s) are present on the device label. GUDID account user information is not made public. Device attribute information can be submitted through two ways:

1. GUDID FDA Interface 2. HL7 SPL submission

A GUDID account is required regardless of the submission method chosen by the labeler. FDA GUDID Interface : Manual data capture, one record submission at a time. HL7 SPL : Create and submit fully valid SPLs through ESG, Submission of device information as xml files – one record at a time. Should complete ESG account establishment and testing process.

Labeler : Responsible to submit the device information to GUDID. Third Party : A Labeler can authorize a third party to submit the device data on the labeler’s behalf.

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Steps for GUDID Compliance

Class III device manufacturers who applied for a year extension and Class II companies should gear up well

ahead of time in creating GUDID accounts.

The sense of urgency being, it takes time for FDA to process numerous requests pouring in for GUDID

production accounts.

Firstly, a test account will be provided where a labeler has to execute all the possible test submission

scenarios successfully and after proper review a production account would be issued. This whole process

is time consuming.

Once a request is raised FDA will send

an application for GUDID production

account

After receiving the completed application

GUDID will activate the test account

The labeler has to execute all the

possible test scenarios for their devices

GUDID will activate the production account after

reviewing the test scenarios.

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GUDID Data Attributes Device Identifier Information → Issuing Agency → Primary DI Number → Device Count → Unit of Use DI Number → Labeler DUNS Number → Company Name → Company Physical Address → Brand Name → Version or Model Number → Catalog Number → Device Description Commercial Distribution → DI Record Publish Date → Commercial Distribution End

Date → Commercial Distribution Status Secondary DI → Secondary DI Issuing Agency → Secondary DI Number Package DI → Package DI Number → Quantity per Package → Contains DI Package → Package Type

→ Package Discontinue Date → Package Status Customer Contact → Customer Contact Phone → Customer Contact Email Direct Marking → Device subject to Direct Marking

but exempt → DM DI different from Primary DI → DM DI Number Device Status → (HCT/P) → Kit → Combination Product FDA Product Code → Product Code → Product Code Name FDA Listing → FDA Listing Number Premarket → Device Exempt from Premarket

Submission

→ FDA premarket Submission Number → Supplement Number GMDN/FDA PT → Code Device Characteristics → For Single-Use Production Identifiers on Label → Lot/Batch Number → Manufacturing Date → Expiry Date → Serial Number → Donation Identification Number Latex Information → Device required to be labeled as

containing natural rubber latex or dry natural rubber (21 CFR 801.437)

→ Device labeled as “not made with natural rubber latex”

Prescription Status → Prescription Use (Rx) → Over The Counter (OTC)

MRI Safety Status → What MRI safety information does

labeling contain? Clinically Relevant Size → Size Type → Size Value → Size Unit of Measure → Size Type Text Storage and Handling Type → Handling Environment

Atmospheric Pressure (LV and HV) → Handling Environment Humidity

(LV and HV) → Handling Environment

Temperature (LV and HV) → Storage Environment Atmospheric

Pressure (LV and HV) → Storage Environment Humidity (LV

and HV) → Storage Environment Temperature

(LV and HV) → Special Storage Conditions → Unit of measure Sterilization Method → Device packaged as Sterile → Requires Sterilization prior to use.

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UDI MASTER DATA MANAGEMENT

Presenter : Alan

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Master Data Distribution

All the required medical device data is dispersed across various systems within the organization and may not be available in the necessary format. E.g. ERP, PLM, DMS, Excel sheets, Quick books, paper based documents, etc… Required medical device regulatory data should be identified through a well integrated Master Data Management strategy. The acquired data should be migrated, normalized, collated and validated as per FDA guidelines and specifications. Controlled vocabularies also should be identified and normalized according to FDA specifications.

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UDI Data Management

UDI DATA CONVERSION

HL7 SPL COMPLIANCE

Master Data Management Identifying present data and application architecture

Location and Migration of master data present at multiple units and sites

Collection, Aggregation and Refinement of required data

Format Readiness Management

Preparing the product and regulatory data in the required format

Data Normalization and Validation based on FDA requirements

XML Conversion into validated SPL, as per HL7 and FDA 21 CFR Part 11 standards

Proof reading of GUDID data elements and Controlled Vocabularies

Establishment registration, listing and labeling

UDI data reports prepared and sent giving transparency of the submission status

Acquiring FDA GUDID Data Elements (DUNS, GMDN, Product Characteristics, Labeler and Packaging Information, etc)

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Recent Updates Addition of a new PI; Donation Identification Number (DIN). This number is applicable only to HCT/P devices.

Two questions of MRI Safety are combined into one. What MRI safety information does the labeling contain? The LOVs include – MR Safe, MR Unsafe, MR Conditional and Labeling does not contain MRI Safety Information.

New additions to the list of values for Sterilization Method were added.

Changes to list of values for Size Type and Unit of Measure were made.

Date format change for Web Interface entry ONLY from yyyy/mm/dd to yyyy-mm-dd.

Support Contact Phone/Email changed to Customer Contact Phone/Email.

Ability to submit FDA Preferred Term (PT) Codes for GUDID submissions until a GMDN PT code can be obtained from the GMDN Agency.

Sept 10, 2014 FDA Unique Device Identification System has published a Small Entity Compliance Guidance for Industry.

Aug 20, 2014 FDA has released a FAQ for Unique Device Identifier System: Vol. 1.

Aug 15, 2014 FDA’s Center for Devices and Radiological Health (CDRH) has issued a letter extending the September, 2014 UDI compliance deadline by one year for Class III Contact Lens and Intraocular Lens Labelers.

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FREYR LEVERAGE UDI COMPLIANCE EXPERTISE

Presenter : Rajiv

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Freyr Roadmap to UDI Compliance

→ Freyr can assist your organization with FDA’s UDI Compliance to ensure conformance with current regulatory requirements & mandates, manage the Supply Chain, reduce your Product’s Lifecycle and enable faster Time-to-market.

Keeping the timelines in mind, Freyr’s roadmap to help medical device companies to UDI Compliance comprises of a 3-Step Process. This process signifies Freyr’s dedication to assist and support medical device companies to attain industry compliance.

Freyr Consulting and Advisory Services

1. Freyr IDENTITY 2. UDI Enterprise Application Interfaces (Custom

Bolt-on Solutions) 3. Operational Data Management

• Comprehensive Gap Analysis Document

• GUDID Account Creation

• Sample Submission Ready XML Files

• UDI Awareness workshop

• Collation of GUDID Attributes

• Generation of XML documents

• Validation of Data in XML Documents

• Submission of DI Information to GUDID

• Technology Solution • DI Data

Management • HL7/SPL

Compliance • PI Data

Maintenance • Continuous UDI

Support • Training & Support

UDI READINESS ASSESSMENT/ GAP ANALYSIS

DI IMPLEMENTATION & SUBMISSION MANAGEMENT

LIFE CYCLE MANAGEMENT

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Freyr’s Comprehensive UDI Services & Solutions

Freyr IDENTITY

UDI Strategy & Business Consulting

Device Information Lifecycle Management

Freyr UDI Centre of Excellence

(CoE)

Regulatory Intelligence for UDI UDI Technology Services

UDI Managed Services

• UDI Readiness assessment

• Process consulting

• Workshop and training

• UDI data management and harmonization

UDI Strategy & Business Consulting

• Device information lifecycle management

Device Information Management

• Building custom validated Enterprise scale applications

• Barcode, RFID labelling services

• Automatic identification of devices in supply chain

UDI Technology Services

• Device information management

• GUDID Submission

• Production Information management

Freyr IDENTITY

• Maintaining consistent track of all the new guidelines and mandates

Regulatory Intelligence for UDI

• End-to-end Operational UDI data services

• Submissions and validations

UDI Managed Services

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Freyr IDENTITY (UDI Software Solution)

Freyr IDENTITY leverages the Plan, Process and Training methodology to offer an end-to-end UDI compliance solution. XML Conversion: Freyr IDENTITY converts the device attribute data in to XML based on SPL and HL7 protocols

Data Validation: Freyr IDENTITY has an inbuilt Validator that uses GUDID business rules and pre-validates the configured XML data.

Data Submission: The validated XML submission is uploaded to GUDID thru the electronic submission gateway (ESG).

Version Management: Freyr IDENTITY deploys an efficient Version-control system to ensure that the updates made to published device data are captured and organized in indexed and searchable files.

Pre-built Training: Freyr offers a comprehensive pre-built training either in a hosted environment or in the on-premises deployment, to empower skills and enable compliance with UDI practice.

Lifecycle Management: Right from deployment to training and regular maintenance, Freyr IDENTITY offers a complete solution to companies to easily manage multiple lifecycles of the updated, modified device information and frequent submissions.

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Freyr Fact Sheet

o

New Jersey

o London

o

Hyderabad

→ Headquartered in New Jersey, USA with Regulatory Operations & Data Centre in Cranbury, NJ, USA

→ Global Regulatory Operations & Development Centre in Hyderabad, India, Asia’s leading Bio-Tech Hub

→ Robust Information Security and Quality ISO 9001 & ISO 27001 Certified Processes with state-of-the-art infrastructure and BCP & DR site

→ Best-in-class Regulatory Consulting, Technology and high-value/ low-cost Outsourcing Services

→ Rapidly growing strong 350+ team of regulatory, scientific, technology & consulting professionals

o Headquarters Global Operations & Data Center

o

Global Operations & Development Center

Freyr, is a fast-growing, Global Regulatory Solutions & Services company with an exclusive focus on the entire Regulatory value-chain. Freyr specializes in offering high-value Consulting, Software & Operations Outsourcing Services of Regulatory Affairs, Operations & Information Management functions to Large & Small-Medium Life Sciences companies.

Freyr is the preferred partner to Top 10 Fortune 50 Bio-Pharma & Consumer Healthcare and several Small-Medium Pharma & Life Sciences Companies.

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Freyr Regulatory Centers of Excellence (CoE)

CoEs / SERVICES Software / Cloud Process / Business Consulting Outsourcing Services Resource Fulfillment

Regulatory Publishing

Regulatory Affairs

Regulatory CMC

Labeling & Artwork

Regulatory Information Management

Consumer Healthcare Regulatory

Regulatory Intelligence

R&D Software & Support

Health Authority Directives

EVMPD/ IDMP

UDI

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Questions?

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US Headquarters

1 Bell Street, Maidenhead, Berkshire, SL6 1BU Phone +44 1133 508632

103 Carnegie Centre, Suite 300, Princeton, NJ – 08540

1 Farr View Dr, STE 5E , Cranbury Township, NJ 08512

Phone +1 908 345 5984

UK

North America Operations Center

Lanco Hills Technology Park, Manikonda, Hyderabad, India Phone +91 40 4848 0999

India Global Operations Center

[email protected]

Thank You!