UDI Luncheon Seminar - QA Consulting, Inc

UDI Luncheon Seminar April 17th, 2013

Judy L. Bunch, RAC, CQA

Senior Regulatory Affairs Consultant

QA Consulting, Inc.- Confidential 2013

• Date Format (e.g., JUN 30, 2014)

• UDI on label and packages

• Global UDI Database (GUDID) submission

• Direct Part Marking (DPM)

RECAP of PROPOSED

REQUIREMENTS


TOPICS

• GENERAL REGULATORY CONSIDERATIONS

• GUDID MASTER DATABASE SUBMISSIONS

• INTERSECTION OF THE UDI RULE AND

OTHER FDA REGULATIONS


TOPICS






GENERAL REGULATORY CONSIDERATIONS

UNDER THE PROPOSED UDI RULE

• Who is responsible for the UDI requirements?

• What types of devices must meet the UDI requirements?

• What devices are exempt?

• Where is the UDI to be applied?

• Are there exceptions?

• When is a new UDI required?

• What about existing inventory?


Who is Responsible for the UDI Requirements?

The “labeler” is responsible for meeting UDI and GUDID

data submission requirements.


Labeler Definition (21 CFR 801.3)

• “Any person who CAUSES a label to be applied to a device, or who CAUSES the label to be modified, with the intent that the device will be introduced into interstate commerce without any intended subsequent replacement or modification of the label.”

• Usually the manufacturer, but may be a specification developer, single-use device reprocessor, convenience kit assembler, repackager, or relabeler.

• The addition of a distributor’s name and contact information without making any other changes to the label would not be considered a modification.


What Types of Devices Must Meet the Proposed

UDI Requirements?

• Classes I, II, III (certain Class I devices exempt)

• IVDs

• Certain combination products (primary mode of action is that of a device)

• Each device constituent part of a combination product regardless of whether

the combination product is subject to UDI labeling (unless combined in such

a way that the device cannot be used except as part of the combination

product)

• Convenience kits & each device in the

kit must have distinct UDIs (unless a

device is intended for single use)

Anterior cervical fusion kit


What Types of Devices Must Meet the Proposed UDI

Requirements? (continued)

• Stand-alone software (e.g., software that is typically installed on a computer

or multiple computers or on a network and the package/label are no longer

used)

• Each model/version of a device will have a different UDI

ALIF cage PLIF cage TLIF cage


Definition of version/model in Proposed Rule

• Version or model means a device package

containing one or more devices that have

identical specifications, performance, size, and

composition, with specified limits (801.3)


What Devices are Exempt from UDI Requirements (in

the Proposed Rule)?

• Class I devices that FDA has, by regulation,

exempted from the GMP requirements of part

820

▫ Elastic bandage, tuning fork, examination

gown, bedpan, manual toothbrush

• Individual Class I, single-use devices

packaged in multiples, are single use,

and not intended to be sold individually

(next higher level of packaging requires UDI)

▫ Box of patient examination gloves,

box of adhesive bandages


What Devices are Exempt from UDI Requirements in

the Proposed Rule? (continued)

• Devices used solely for research, teaching, or chemical analysis, with no

intended clinical use

• Custom devices

• Veterinary devices not intended for use in humans

• Devices intended for export (other countries may have their own

requirements, however, it is likely they will be compatible)

• Investigational device (per part 812)

• Devices where FDA establishes or recognizes a performance standard

and the standard includes an exception to the UDI requirement




• Single-use devices packaged in a convenience kit

• Shipping containers (a package, container, or pallet whose contents and

quantity may vary between shipments)


• A device constituent part of a combination product that is impossible to use except as part of

the combination product

Drug-eluting stent Iontophoretic transdermal system

- PMOA = device - PMOA = drug

- UDI required for Combination product - UDI not required for combination product

- Separate UDI not required for stent - UDI not required for device component

(cannot be used except as part of combo)




Class I Exemptions Class I devices that are: Are exempt from:

Exempt from GMP

regulations

UDI (neither the device and production

identifier are required)

Not exempt from GMP

regulations

Exempt from production identifier, e.g.,

lot number, serial number, expiration

date, manufacturing date (only the

device identifier is required)

Individual Class I, single-

use devices packaged in

multiples, are single use,

and not intended to be

sold individually (next

higher level of packaging

requires UDI)

UDI (neither the device and production

identifier are required)


Where is the UDI to be Applied?

• Device label

• Device’s packaging (each level of packaging that always contains a specific number of devices)

• Direct part marking (DPM) for certain devices - Devices that are likely to remain in use for extended periods of time and are likely to become separated from their labeling.

▫ Implantable

▫ Intended for more than one use & to be sterilized before each use

▫ Stand-alone software

Direct part marking UDI may be identical to the label/package or it may be a unique UDI distinguishing the unpackaged from the packaged form of the device


If a Device is Not Exempt, Are There

Exceptions?

Exceptions to

the requirement

for a device to:

Required

communication

with FDA

Proposed

Regulation

FDA

response

Permissible to

include

request/notification

in premarket

submission?

Bear a UDI

(Exceptions or

alternatives)

Formal request

801.35

Response

from FDA is

required

Yes

Bear a DPM

Notification

801.50(g)

FDA will not

respond

unless they

have

questions

Yes


UDI Exceptions/Alternatives

Requests must include (801.35):

• Identification of the device

• Identification of the UDI requirements that are the subject of the request for exception or alternative

• If requesting an exception, explanation of why the UDI labeling requirements are not technologically feasible

• If requesting an alternative, description and explanation of how it would be more accurate, more precise, or provide for more rapid identification

• Provide an estimate of the number of devices that would be affected if the exception/alternative is granted.

Note: Response from FDA is required.


DPM Exceptions

Proposed Criteria:

• If DPM would interfere with the safety and effectiveness of use

• DPM is not technologically feasible (can include economic considerations for a very small firm)

• Device is intended to remain implanted continuously for < 30 days

• The device has previously been directly marked

• Device is sold at retail and bears a UPC

• Software that is not stand-alone but is a component of a medical device


DPM Exceptions

Steps to take:

• Document justification in the DHF and

• Submit a notice to FDA per 801.50(g) to include:

▫ Identification of the exception being invoked

▫ Explanation of the factors making the exception applicable to the

device

▫ Name, contact information for the person who determined that the

exception is applicable to the device

Note: FDA will not routinely respond to these notices but may ask for

additional information


When is a New UDI Required?

• New version or model of a device (see 830.3), for example: ▫ Specifications

▫ Performance

▫ Size

▫ Composition

• Change in quantity of devices in a package (this creates a new device package)

• Add a new device package

• Change from nonsterile package to a sterile package or sterile to nonsterile packaging

• Relabeling (must also keep a record showing the relationship of the prior device identifier)


• The implementation date for your device means

that all devices distributed from that day on must

comply with the UDI regulation.

• Existing inventory: FDA may use enforcement

discretion, i.e., for a period of time after the

implementation date.

What about existing inventory?


TOPICS






Global UDI Database (GUDID)

• What is the required dataset for GUDID submissions?

• How do I obtain the GMDN codes for my devices?

• How is the GUDID data to be submitted?

• When will the GUDID submission be required?

• Will FDA provide any assistance with GUDID

submissions?

• How should labelers go about gathering and maintaining

GUDID master data?


What is the Required Master Dataset for GUDID

Submissions (from the Proposed Regulation)?

For EACH model or version of a device:

• Device Identifier [GTIN, UPN] associated with the version or model

• Type of production identifiers on the label (i.e., expiration date, date

of manufacture, serial number, or lot or batch– not the actual

production identifier)

• UDI issuing agency (GS1, HIBCC)

• Labeler contact name, phone, email

• Whether direct part marking is required and, if so, associated UDI

information

• Proprietary/Brand/Trade Name as it appears on the label of the

device

• Version/model number (or other reference number)


What is the Required Master Dataset for GUDID

Submissions? (continued)

• Whether packaged sterile

• Whether the device contains natural rubber latex

• Clinically relevant size of particular version or model with unit of

measure (if available in more than one size)

• Quantity in each device package

• FDA premarket submission number (or statement of exemption)

• Listing Number (the only information not made public)

• Global Medical Device Nomenclature (GMDN) Classification

code/term

Note: Potential to add additional elements in the Final Rule


How Do I Obtain the GMDN Codes

for My Devices?

• GMDN Agency (http://www.gmdnagency.com)

• Currently must purchase license(s) (cost based

on volume) – initial fee with annual renewal

• FDA is working with the GMDN Agency to make

the data publicly available

http://www.gmdnagency.com/


How is the GUDID Data to be

Submitted?

• Assign a point of contact (who may designate a 3rd party to

provide the information on their behalf)

• Two methods of submission: ▫ Via FDA’s Electronic Submission Gateway using Structured Product

Labeling (SPL) conforming to ANSI/Health Level Seven (HL7) format

(aka HL7 SPL)

▫ Web based entry for low-volume data


When Will the GUDID Submission be

Required? At the same time as a UDI is required for a device:

Type of device GUDID submission will be

required (from date of Final

Rule):

Class III One year

Implantable, life-supporting, life-

sustaining not in class III Two years

Class II Three years

Class I Five years


When Will Updates to the GUDID

Submission be Required?

Updates are required whenever the information changes:

• No later than the date a device is first labeled with the

changed information

OR

• If the information does not appear on the label, the

update is required within 10 business days of the

change


Will FDA Provide Any Assistance

with GUDID Submissions?

FDA will soon publish a GUDID User Guide designed to describe:

• How the GUDID works

• How to access it

• How to create an account

• Define each database element/how to answer each question

(e.g., trade name vs. brand name)

• Business rules


How Should Labelers Go About Gathering and

Maintaining GUDID Master Data?

1. Define a team champion and the parts of the organization that will be

involved

2. Define the process of gathering the data

3. Convert the UDI data to FDA required format (HL7 SPL) unless the web tool

will be used

4. Validate the UDI data

5. Submit UDI data to FDA

FDA’s Electronic Submissions Gateway using SPL format

FDA’s web tool

6. Maintain the data

7. Submit revisions as the attributes change over time


Considerations:

• FDA’s requirements are anticipated to change over time

as new needs are identified

• FDA may add specific requirements for specific device

types

• As other countries develop their UDI requirements they

may require additional data attributes


TOPICS






Intersection of UDI with Other FDA

Regulations

• What is the relationship of UDI to other regulatory

requirements/submissions?

• What types of Quality System additions/modifications will

be necessary?

• What should “labelers” do next?


What is the Relationship of UDI to Other

Regulatory Requirements/Submissions?

• No direct relationship to clearance or approval submissions

▫ If UDI is changed, no submission or supplement is needed

▫ If a device is changed via a supplement or Special 510(k), most

likely no UDI change is required unless it is a new model/version

▫ Exception/Alternative requests and/or DPM exception notices can

be included in a submission



Regulatory Requirements/Submissions? (cont.)

The following are specified in the Proposed Regulations:

• PMA periodic reports for Class III devices will include device identifier information and changes

• UDI will be a data element in:

▫ MDR (all reporting organizations must provide UDI)

▫ Corrections and Removals (CARs) – reports to FDA and internal records of CARs not required to be reported are to include a UDI or other identifier

▫ Recalls – FDA will include UDIs in their cease distribution and notification orders




• Quality Systems Regulation changes: ▫ Inspection of labels to include examination of UDI accuracy

▫ Device history record to include any UDI used

▫ Complaint files must include the UDI

▫ Service reports must include UDI

• Recordkeeping ▫ Records linking all UDIs used to identify each version/model.

▫ Retain for the linking records for 3 years from the date the labeler

ceases to market the version/model

▫ Records of rationale for any exceptions

▫ GUDID Master Data




• Medical Device Tracking (Subject to FDA orders) –UDI may be

used as the tracking method

▫ e.g., TMJ prosthesis, mechanical heart valve, implantable

pacemaker, implantable infusion pumps, silicone gel-filled breast

implants; devices used outside a user facility such as continuous

ventilators, DC-defibrillators, ventricular bypass assist devices.

• Postmarket Surveillance (Subject to FDA orders) – will include

UDI




• Compliance – Inspectional Program:

UDI compliance will now be part of

FDA inspections


What Types of Quality System

Additions/Modifications Will Be Necessary?

• Generate a Quality Plan for UDI implementation

• Incorporate the new date format and UDI into device design using

design control process, including design requirements, design

outputs, verification and validation, and design history files

• Consider UDI in Risk Management activities, e.g., update FMEA

• Format of UDI, printing process and equipment, affixing process

• Process for when and how to obtain a new UDI

• Process for gathering, validating, and maintaining the GUDID

Master Dataset

• Training on UDI implementation

• Incorporate UDI into procedures for complaints, MDR, corrections

and removals, recalls, service reports


What Types of Quality System

Additions/Modifications Will Be Necessary? (cont.)

• Other processes that may be affected:

▫ Storage and distribution

▫ Purchasing/supplier requirements

▫ Manufacturing process

▫ Quality

▫ Regulatory

• Update recordkeeping requirements for records required by

the UDI and for records required by new processes

• Update supplier and distributor agreements

• Include UDI in internal audit plans

Initial Implementation Plan

UDI Luncheon Seminar - QA Consulting, Inc

Documents