UDI Luncheon Seminar April 17 th, Judy L. Bunch, RAC, CQA Senior Regulatory Affairs Consultant

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1 UDI Luncheon Seminar April 17 th, 2013 Judy L. Bunch, RAC, CQA Senior Regulatory Affairs Consultant

2 RECAP of PROPOSED REQUIREMENTS Date Format (e.g., JUN 30, 2014) UDI on label and packages Global UDI Database (GUDID) submission Direct Part Marking (DPM)

3 TOPICS GENERAL REGULATORY CONSIDERATIONS GUDID MASTER DATABASE SUBMISSIONS INTERSECTION OF THE UDI RULE AND OTHER FDA REGULATIONS

4 TOPICS GENERAL REGULATORY CONSIDERATIONS GUDID MASTER DATABASE SUBMISSIONS INTERSECTION OF THE UDI RULE AND OTHER FDA REGULATIONS

5 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?

6 Who is Responsible for the UDI Requirements? The labeler is responsible for meeting UDI and GUDID data submission requirements.

7 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.

8 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

, software that is typically installed on a computer

package/label are no longer used) Each model/version

9 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

10 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)

tuning fork, examination gown, bedpan, manual toothbrush Individual Class I, single-use devices packaged in

11 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

12 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

13 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)

combination product Drug-eluting stent Iontophoretic transdermal system - PMOA = device - PMOA = drug - UDI required for

14 What Devices are Exempt from UDI Requirements in the Proposed Rule? (continued) 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)

15 Class I Exemptions Class I devices that are: Are exempt from: Exempt from GMP regulations Not exempt from GMP regulations UDI (neither the device and production identifier are required) Exempt from production identifier, e.g., lot number, serial number, expiration date, manufacturing date (only the device identifier is required) Individual Class I, singleuse 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)

16 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

17 If a Device is Not Exempt, Are There Exceptions? Exceptions to the requirement for a device to: Bear a UDI (Exceptions or alternatives) Required communication with FDA Proposed Regulation Formal request FDA response Response from FDA is required Permissible to include request/notification in premarket submission? Yes Bear a DPM Notification (g) FDA will not respond unless they have questions Yes

18 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.

19 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

20 DPM Exceptions Steps to take: Document justification in the DHF and Submit a notice to FDA per (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

21 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)

22 What about existing inventory? 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.

23 TOPICS GENERAL REGULATORY CONSIDERATIONS GUDID MASTER DATABASE SUBMISSIONS INTERSECTION OF THE UDI RULE AND OTHER FDA REGULATIONS

24 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?

25 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, 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)

26 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

27 How Do I Obtain the GMDN Codes for My Devices? GMDN Agency ( 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

28 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

29 When Will the GUDID Submission be Required? At the same time as a UDI is required for a device: Type of device Class III Implantable, life-supporting, lifesustaining not in class III Class II Class I GUDID submission will be required (from date of Final Rule): One year Two years Three years Five years

30 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

31 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

32 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

33 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

34 TOPICS GENERAL REGULATORY CONSIDERATIONS GUDID MASTER DATABASE SUBMISSIONS INTERSECTION OF THE UDI RULE AND OTHER FDA REGULATIONS

35 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?

36 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

37 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

38 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

39 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

40 What is the Relationship of UDI to Other Regulatory Requirements/Submissions? (cont.) Compliance Inspectional Program: UDI compliance will now be part of FDA inspections

41 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

42 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

43 Initial Implementation Plan

Unique Device Identification (UDI) Jay Crowley Senior Advisor for Patient Safety Food and Drug Administration

Unique Device Identification (UDI) Jay Crowley Senior Advisor for Patient Safety Food and Drug Administration jay.crowley@fda.hhs.gov 301-980-1936 1 History of FDA s UDI Project 2004 FDA Pharmaceutical