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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
QA Consulting, Inc.- Confidential 2013
TOPICS
• GENERAL REGULATORY CONSIDERATIONS
• GUDID MASTER DATABASE SUBMISSIONS
• INTERSECTION OF THE UDI RULE AND
OTHER FDA REGULATIONS
QA Consulting, Inc.- Confidential 2013
TOPICS
• GENERAL REGULATORY CONSIDERATIONS
• GUDID MASTER DATABASE SUBMISSIONS
• INTERSECTION OF THE UDI RULE AND
OTHER FDA REGULATIONS
QA Consulting, Inc.- Confidential 2013
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?
QA Consulting, Inc.- Confidential 2013
Who is Responsible for the UDI Requirements?
The “labeler” is responsible for meeting UDI and GUDID
data submission requirements.
QA Consulting, Inc.- Confidential 2013
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.
QA Consulting, Inc.- Confidential 2013
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
QA Consulting, Inc.- Confidential 2013
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
QA Consulting, Inc.- Confidential 2013
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)
QA Consulting, Inc.- Confidential 2013
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
QA Consulting, Inc.- Confidential 2013
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
QA Consulting, Inc.- Confidential 2013
What Devices are Exempt from UDI Requirements in
the Proposed Rule? (continued)
• Single-use devices packaged in a convenience kit
• Shipping containers (a package, container, or pallet whose contents and
quantity may vary between shipments)
QA Consulting, Inc.- Confidential 2013
• 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)
What Devices are Exempt from UDI Requirements in
the Proposed Rule? (continued)
QA Consulting, Inc.- Confidential 2013
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)
QA Consulting, Inc.- Confidential 2013
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
QA Consulting, Inc.- Confidential 2013
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
QA Consulting, Inc.- Confidential 2013
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.
QA Consulting, Inc.- Confidential 2013
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
QA Consulting, Inc.- Confidential 2013
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
QA Consulting, Inc.- Confidential 2013
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)
QA Consulting, Inc.- Confidential 2013
• 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?
QA Consulting, Inc.- Confidential 2013
TOPICS
• GENERAL REGULATORY CONSIDERATIONS
• GUDID MASTER DATABASE SUBMISSIONS
• INTERSECTION OF THE UDI RULE AND
OTHER FDA REGULATIONS
QA Consulting, Inc.- Confidential 2013
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?
QA Consulting, Inc.- Confidential 2013
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)
QA Consulting, Inc.- Confidential 2013
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
QA Consulting, Inc.- Confidential 2013
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
QA Consulting, Inc.- Confidential 2013
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
QA Consulting, Inc.- Confidential 2013
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
QA Consulting, Inc.- Confidential 2013
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
QA Consulting, Inc.- Confidential 2013
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
QA Consulting, Inc.- Confidential 2013
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
QA Consulting, Inc.- Confidential 2013
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
QA Consulting, Inc.- Confidential 2013
TOPICS
• GENERAL REGULATORY CONSIDERATIONS
• GUDID MASTER DATABASE SUBMISSIONS
• INTERSECTION OF THE UDI RULE AND
OTHER FDA REGULATIONS
QA Consulting, Inc.- Confidential 2013
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?
QA Consulting, Inc.- Confidential 2013
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
QA Consulting, Inc.- Confidential 2013
What is the Relationship of UDI to Other
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
QA Consulting, Inc.- Confidential 2013
What is the Relationship of UDI to Other
Regulatory Requirements/Submissions? (cont.)
• 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
QA Consulting, Inc.- Confidential 2013
What is the Relationship of UDI to Other
Regulatory Requirements/Submissions? (cont.)
• 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
QA Consulting, Inc.- Confidential 2013
What is the Relationship of UDI to Other
Regulatory Requirements/Submissions? (cont.)
• Compliance – Inspectional Program:
UDI compliance will now be part of
FDA inspections
QA Consulting, Inc.- Confidential 2013
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
QA Consulting, Inc.- Confidential 2013
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