FREYR UDI VISION SERIES SESSION 3 - DI & PI


FREYR UDI VISION SERIES PART 3 – DI and PI

Date: 5th Dec 2014

3 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING

Session 3 - Agenda

1. Understanding UDI and Packaging

2. UDI Device Types

3. PT Code and PMA

4. 21 CFR Part 11 Requirements for UDI

5. Next steps, Benefits and Exceptions

6. Q&A

DISCLAIMER: All images, pictures showcased are property of their respective legal owners and are used for illustrative / information purposes only.

SESSION 1 – AGENDA

1. Overview - UDI

2. GUDID Components

3. UDI – Master Data Management

4. Freyr Leverage – UDI Expertise

5. Freyr IDENTITY – UDI Software Solution

6. Freyr Corporate Overview

7. Q&A

SESSION 2 – AGENDA

1. Freyr Fact Sheet

2. UDI Labeling & Barcode Standards

3. RFID in Medical Devices

4. UDI Labeling for Different Device Types

5. Exemptions and Highlights

6. Q&A


→ 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 with an office in Maidenhead, UK

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

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

Freyr, is a fast-growing, Global Regulatory Solutions & Services company with an exclusive focus on the entire Regulatory value-chain

Freyr Consulting and Advisory Services

1. Freyr IDENTITY – Stand alone Software for UDI 2. Freyr ACCELERATE - Building custom validated

Enterprise scale applications coupled with Freyr Identity solution (Custom Bolt-on Solutions)

3. Operational Data Management

UDI READINESS ASSESSMENT/ GAP ANALYSIS

DI IMPLEMENTATION & SUBMISSION MANAGEMENT

LIFE CYCLE MANAGEMENT

Freyr in the UDI Space

Freyr Fact Sheet


Presenter : Prasanna

Understanding UDI and Packaging


Device Identifiers (DI)

A mandatory, fixed portion of a UDI that identifies:

• Labeler, Device status and Characteristics, Premarket Submission

• Specific version or model, Product codes (FDA Listing number, PT code, GMDN code)

• Package configuration

• Storage conditions

• Clinically relevant size

• Sterilization methods

• MRI status

• Latex information


Primary DI The Primary Device Identifier is an identifier that is the main (primary) lookup for a medical device product and meets the requirements to uniquely identify a device through its distribution and use. The primary DI number will be located on the base package, which is the lowest level of a medical device containing a full UDI.

Unit of Use DI A virtual identifier assigned to an individual medical device when a UDI is not labeled on the individual device at the level of its unit of use. Its purpose is to associate the use of a device to/on a patient when a base package contains more than one device.

Secondary DI An identifier that is an alternate (secondary) lookup for a medical device that is issued from a different FDA accredited issuing agency than the primary DI.

Package DI A device identifier for the package configuration that contains multiple units of the base package. It does not include shipping containers.


Packaging Configuration

Package Configurations inherits Base package device attribute values.

Example 1: Primary DI is different from Unit of Use DI


Packaging Configuration Example 2 : Primary DI is same as base package DI


DI Record States: The DI record state determines the applicable business rules and the GUDID functionality available to users. New DI record may be saved in one of the following three DI record states:

1. Draft DI record 2. Unpublished DI record 3. Published DI record.

Draft DI

• Can be edited an unlimited number

of times.

• Can be saved in the Draft state for 180 calendar days in GUDID database.

• It is not available for public search

and retrieval.

Unpublished DI

• DI record has passed all business

rules.

• Publish Date > today.

• It can be edited unlimited number of times.

• is not available for public search

and retrieval.

Published DI

• Publish Date =<today.

• DI record is available for public

search and retrieval.

• It is subject to editing limitations as determined by the Grace Period. The Grace Period is 30 calendar days and starts the day after the DI record is published.


A conditional, variable portion of a UDI. If any of the following is included in the label of a device, it must

also be included in the DI submission record. Any identifiers other than the five listed below are outside

the scope of FDA regulated UDI.

• Lot or Batch number

• Serial number

• Expiration date

• Manufacturing date

• Donation Identification Number for HCT/P regulated devices

Production Identifier(s) (PI)


Significance of Production Identifiers 1. Serial Number A Serial Number is typically used on medical devices that need to be individually tracked and traced (e.g pacemakers, MRI scanners). 2. Lot/Batch Number The batch code/lot number is used for tracking medical device for device recall, quality control check, calculate expiration dates. 3. Donation Identification Number HCT/Ps must carry a distinct identification code that relates each HCT/P to the donor and all records pertaining to the donor, and that labeling include information to facilitate effective tracking. 4. Manufacturing Date It is the production date of a product. It may be included in the batch code or serial number. 5. Expiration date An Expiration Date indicates the limit of consumption or use of a product.

Significance: The PI parameters like Serial Number, DIN or Lot/Batch

number are mandated by UDI ruling so as to enhance the track and trace of the devices for eHR, AE / product quality complaint (PQC) reporting mechanism i.e., post-market surveillance (PMS) and product recalls.

Companies that have implemented the RFID technology may embed the these parameters within the RFID chip and track them throughout the supply chain.

RFID enabled warehouses can also track and prevent the expired or near expiry devices from entering the market.

Hospital warehouses may also scan the barcode and immediately identify if the medical device is in good health.



UDI Device Types


Configurable medical device system

A configurable system consists of several components which can be assembled in multiple configurations. Those individual components may be medical devices themself and/or nonmedical devices. Examples: Computed Tomography (CT) systems, Ultrasound systems, Anesthesia systems, Radiology Information System (RIS).

Configuration

Configuration is a combination of items of equipment, as specified by the manufacturer, that operate together to provide an intended use or purpose as a medical device. The combination of items may be modified, adjusted or customized to meet a customer need. Examples: 1. CT: gantry, tube, table and console are items of equipment that can be configured/combined to deliver an intended function. 2. Anesthesia: ventilator, breathing circuit and vaporizer are items of equipment that can be configured / combine to deliver an intended function.

Kits Kits are a collection of products, including medical devices, that are packaged together to achieve a common intended use and is being distributed as a medical device. These could also be called procedure packs or convenience kits.


Example for Configuration System

Component Number

Catalogue Number

Components

1 C1222 Smooth Shank Screws

2 C1223 Cross Connectors

3 C1224 Dovetail Set Screws

4 C1225 Straight Rod Spinal Implant


Example for Kit

Component No Name of Component

1 Semicircular Arc

2 Instrument Carrier

3 Instrument Stop Holder

4 Instrument Guide Holder

5 Coordinate Setting Axis

6 Counter Scale Axis

7 Instrument Screw Driver

8 Guide Insert

9 Twist Drill

2 4 3

7 1

9

6 5

8

Stereotactic system



PT Code and PMA


FDA Product Code Classification for premarket devices issued by FDA as three letter code

Product code are assigned by in FDA approval or in clearance letter

GMDN Code and FDA PT Code

Each GMDN Preferred Term has 3 components: Preferred Term Code, Preferred Term Name, and Preferred Term Description

A GMDN Preferred Term can be identified by either the GMDN PT Code or the corresponding FDA PT Code If the DI Record needs to be submitted prior to obtaining the GMDN PT Code from the GMDN Agency, the FDA Preferred Term Code equivalent may be submitted

Either GMDN code or FDA PT code is required


FDA PT Code and GMDN Code

FDA PT Code

Unique four letter alphabetical code created by the FDA. Example: Hyperthermia System FDA PT code : HXKT PT name : Hyperthermia System PT Definition: A mains electricity (AC-powered) device assembly designed for controlled heating (i.e., temperatures above 43° Celsius) of the body using microwaves, for the treatment of malignant or benign tumours or other disease conditions [e.g., benign prostatic hyperplasia (BPH), prostatitis]. It includes a microwave generator, controls, software (e.g., treatment planning software) and a microwave applicator. It is intended for both whole-body and localized heating of tissues/organs through either externally-mounted components or from catheter- or probe-type applicators inserted topically, endoscopically, or surgically.

GMDN Code

Unique five digit numeric code used to identify common device types.

Example: Hyperthermia System GMDN code : 40783 PT name : Radio-frequency Hyperthermia System PT Description : A mains electricity (AC-powered) device assembly designed for controlled heating (i.e., temperatures above 43° Celsius) of the body using radio-frequency (RF) energy, for the treatment of malignant or benign tumours, or other disease conditions. It includes a RF generator, controls, software and a microwave applicator. It is intended for both whole-body and localized heating of tissues/organs through either externally-mounted components or from catheter- or probe-type applicators inserted topically, endoscopically, or surgically.


Premarket Submission Type

Premarket Submission Type

Premarket Submission

Prefix

Submission Number Format

Supplement Number Format

PMA P 1 alpha, 6 digits 1-3 digits

510(k) K 1 alpha, 6 digits 1-3 digits

HDE H 1 alpha, 6 digits 1-3 digits

PDP D 1 alpha, 6 digits 1-3 digits

NDA N 1 alpha, 5 or 6 digits 1-3 digits

PMA BP 2 alpha, 6 digits 3-4 digits

510(k) BK 2 alpha, 6 digits 3-4 digits

HDE BH 2 alpha, 6 digits 3-4 digits

BLA (Licensed IVD) BL 2 alpha, 6 digits 3-4 digits



21 CFR Part 11 Requirements for UDI


There are two requirements necessary for Part 11 applicability: 1) Records that are required to be maintained (under predicate rules) or submitted to FDA 2) Records that are kept in electronic format, as opposed to paper The records that are submitted to GUDID should comply with Part 11 requirements. But the record developed to collect all the data elements required to be entered into a device record via the GUDID web user interface, is not subject to part 11 requirements. The HL7 SPL solution must be compliant with the requirements of part 11 The GUDID SPL submission doesn’t require a signature; therefore, part 11 requirements specific to electronic signatures do not apply Digital certificate serves to authenticate the sender and is required for all submissions to the FDA ESG Third-party submitters or solution providers are not responsible to the FDA to meet regulatory requirements for UDI or part 11 It is the legal responsibility of the labeler (or data owner) to meet the record requirements for 21 CFR 830.360 and the requirements of 21 CFR Part 11

21 CFR Part 11 Requirements for UDI


Lifecycle Management

FDA has already mentioned that it is not going to store any Production Identifier (PI) information. The responsibility of maintaining the PI information is of the manufacturer. Medical device companies need to store and maintain the PI information for future regulatory and quality audits. Here are some of the major challenges medical device companies are facing in complying with UDI ruling:

1. Submission Management

2. Submission Repository

3. Submission Revisions

4. Device Discontinuation

5. PI Data Management

6. Recall Updates to PI Data



Next steps, Benefits and Exceptions


Review GUDID ruling

Prepare a work plan

Attend Workshops and webinars

Identify a lead / project manager within the organization for handling UDI project

Know your compliance dates for each of your devices

Identify internal sources for device attribute data

Approach a third party labeler for DI record submissions (if required)

Request for GUDID preproduction account and Test via your submission account

Submit your device DI record

DI Submission - TO DO


UDI Benefits

Allows more accurate reporting, reviewing and analysing of adverse event reports Reducing medical errors by enabling health care professionals and others to more rapidly and precisely identify a device A more robust post-market surveillance system can also be leveraged to support premarket approval or clearance of new devices and new uses of currently marketed devices Providing a standardized identifier that will allow manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls Providing a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies Leading to the development of a medical device identification system that is recognized around the world Traceability of medical devices, especially for field safety corrective actions The use of UDI System will facilitate and simplify the documentation of medical device use in various patient records including traditional as well as electronic health records and registries


Exceptions

FDA Listing Numbers are required for all medical devices except: HCT/P, Kits and Licensed IVDs.

The FDA Product Code is required for all medical devices except for Kits and Licensed IVD (indicated by a

premarket number beginning with a BL).

Nov 19, 2014 - US FDA extended UDI Compliance Deadline for some single-use implantable devices to

September 24, 2016 that meet all of the following criteria:

(1) Intended to be sterilized (or cleaned and sterilized) before use.

(2) Single use implants

Most of the devices that meet these two criteria are supplied non-sterile by the manufacturer.


GUDID Information Basics, Guidance, Account Request, GUDID Web Interface, HL7 SPL, GUDID Status www.fda.gov/udi UDI Help Desk http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/ucm368904.htm IMDRF – www.imdrf.org

Credits


Questions? Please submit the questions in

the question panel

You may direct any queries to [email protected]


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

Thank You!

FREYR UDI VISION SERIES SESSION 3 - DI & PI

Healthcare

Transcript of FREYR UDI VISION SERIES SESSION 3 - DI & PI