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1 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING www.freyrinc.com CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
WELCOME TO FREYR UDI VISION SERIES
The webinar will begin shortly!
2 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING www.freyrinc.com CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
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
4 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
→ 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
→ Best-in-class Regulatory Consulting, Technology and high-value/ low-cost Outsourcing Services
→ Rapidly growing strong 350+ team of regulatory, scientific, technology & consulting professionals
→ 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
5 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
Presenter : Prasanna
Understanding UDI and Packaging
6 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
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
7 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
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.
8 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
Packaging Configuration
Package Configurations inherits Base package device attribute values.
Example 1: Primary DI is different from Unit of Use DI
9 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
Packaging Configuration Example 2 : Primary DI is same as base package DI
10 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
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.
11 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
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)
12 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
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.
13 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
Presenter : Prasanna
UDI Device Types
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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.
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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
16 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
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
17 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
Presenter : Prasanna
PT Code and PMA
18 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
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
19 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
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.
20 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
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 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
Presenter : Prasanna
21 CFR Part 11 Requirements for UDI
22 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
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
23 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
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
24 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
Presenter : Prasanna
Next steps, Benefits and Exceptions
25 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
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
26 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
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
27 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
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.
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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
29 CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING www.freyrinc.com CONSULTING | TECHNOLOGY | OPERATIONS | AFFAIRS | OUTSOURCING
Questions? Please submit the questions in
the question panel
You may direct any queries to marketing@freyrsolutions.com
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UK
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