Global Unique Device Identification Database (GUDID); Draft Guidance

Transcription

1 One Boston Scientific Place Natick, MA (508) Tel (508) Fax November 25, 2013 Divisions of Docket Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD RE: Docket No. FDA-2013-D-0636, Notice Dear Sir or Madam, Boston Scientific Corporation appreciates the opportunity to provide comments in response to the Food and Drug Administration ( FDA or the Agency ) Federal Register notice of September 24, 2013 announcing the availability of Global Unique Device Identification Database (GUDID); Draft Guidance. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices. For more than 30 years, Boston Scientific has advanced the practice of less-invasive medicine by providing a broad and deep portfolio of innovative products, technologies and services across a wide range of medical specialties. Boston Scientific s products help physicians and other medical professionals improve their patients quality of life by providing alternatives to surgery. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Boston Scientific has long recognized the value of unique device identification and has been a leader in this area for more than a decade. Today, all of our devices bear unique identification from the following issuing agencies: HIBCC or GS1 standards organizations. Boston Scientific supports FDA s effort to develop unique device identification systems for medical devices and associated tools. A clear and accurate guidance for industry regarding the Global Unique Device Identification Database (GUDID) will assist device labelers and FDA in obtaining consistent and accurate data. We appreciate the opportunity to provide our comments on the GUDID Draft Guidance, as well as FDA s time in reviewing them. Page 1 of 21

2 This guidance is intended primarily to provide information about submitted data from device labelers who are responsible for inputting the data to the GUDID. However in reviewing the detail of the guidance, further clarity is necessary to enable device labelers to adequately prepare GUDID submissions in a timely and least burdensome manner. Moreover, there are inconsistencies between the Unique Device Identification (UDI) Final Rule and the GUDID Draft Guidance creating further confusion and necessitates changes to this document and perhaps to the database. The comments below cover Boston Scientific s general comments as they apply to the guidance overall followed by more detailed, specific comments. GENERAL COMMENTS 1. Inconsistencies with FDA UDI Rule The GUDID data elements are identified in Appendix B of the GUDID Draft Guidance. Overall, this Appendix is very useful and an important element of the Guidance for device labelers. However, the column titled Required? is unclear if the data element is required/not required based on regulatory requirements or system validation requirements (controlling whether a DI record would be accepted or rejected). The meaning of required should be clarified so that BOTH regulatory and system validation requirements are clearly identified in this guidance. More importantly, some of the data elements identified as required in Appendix B of the GUDID Draft Guidance are inconsistent and create conflicting requirements with the UDI Rule. BSC strongly recommends modifications be made to the GUDID Guidance and the GUDID to ensure requirements are consistent with 21 CFR 830. The information required in the GUDID is outlined specifically in 21 CFR Additionally, 21 CFR Voluntary submission of ancillary device identification information states: (a) You may not submit any information to the Global Unique Device Identification Database (GUDID) other than that specified by , except where FDA acts to permit the submission of specified additional types of information, termed ancillary information. Therefore, the attributes identified as required in Appendix B of the GUDID Draft Guidance and subsequently the GUDID itself must be consistent with and any data elements that are outside of must be considered as voluntary submission requirements for the device labeler. The following sections outline those GUDID data elements which are inconsistent with Page 2 of 21

3 1.1. Version or Model Numbers and Catalog Number 21 CFR Information required for unique device identification states: The contact for device identification designated under (a) shall provide FDA with the following information concerning each version or model of a device required to bear a unique device identifier (UDI) on its label: (b)(5) Any version or model number or similar reference that appears on the label of the device;[emphasis added] The definition of two data elements as defined in the GUDID Draft Guidance are provided below: Version or Model Number: The version or model number found on the device label or accompanying packaging used to identify a category or design of a device. The version or model means all devices that have specifications, performance, size, and composition, within limits set by the labeler. Catalog Number: The catalog, reference, or product number found on the device label or accompanying package to identify a particular product. The version or model number or similar reference as identified in (b)(5) is not clearly identified between these two data elements of the GUDID and need further clarification by FDA. Furthermore, Appendix B of the GUDID Draft Guidance indicates the Version or Model Number is required in the GUDID and a Catalog Number is not required. This is inconsistent with (b)(5) and if a version or model number is required in the GUDID without the allowance for other similar reference it will force device labelers to input reference numbers (Catalog Number) into the Version or Model Number data element; compromising data quality. Therefore, the Version or Model Number data element should NOT be a system required data element; rather device labelers should be allowed enter either a Version or Model Number or Catalog Number. Figure D1 in the GUDID Draft Guidance provides a mapping of a device label to GUDID data elements. It is important to note this example label does not include a version or model number, rather only includes a catalog number. Furthermore, (b)(5) requires the device labeler to enter any version or model number or similar reference that appears on the label of the device. Therefore if the version or model number does NOT appear on the label of the device it cannot be a required element of the GUDID. Similarly, version or model number of a device is not required to be placed on the label per 21 CFR 801 and therefore cannot be a required element of the GUDID. Page 3 of 21

4 1.2. New DI Trigger 21 CFR Changes that require use of a new device identifier states: (a) Whenever you make a change to a device that is required to bear a unique device identifier (UDI) on its label, and the change results in a new version or model, you must assign a new device identifier to the new version or model. (b) Whenever you create a new device package, you must assign a new device identifier to the new device package. However, Appendix B of the GUDID Draft Guidance identifies data elements other than a new version or model and a new device package as triggering a new device identifier (DI). These data elements include: Brand Name and Device Required to be Labeled as Containing Natural Rubber Latex or Dry Natural Rubber. The brand name of a device does not always result in a new version or model change nor does it create a new device package. For example, the brand name of a device could change on a medical device due to marketing or business reasons. For example, a rebranding of a product line may occur as a result from an acquisition or a change in market strategy. Similarly a material change on a medical device often does not result in a version or model change. Therefore, in these situations the version or model number and contents of the device package remain unchanged and are not required to use a new device identifier per Substitution Device Identifier (DI) 21 CFR Information required for unique device identification states: The contact for device identification designated under (a) shall provide FDA with the following information concerning each version or model of a device required to bear a unique device identifier (UDI) on its label: (b)(2) When reporting a substitution of a new device identifier that will be used in lieu of a previously reported identifier, the device identifier that was previously assigned to the version or model; However, the GUDID Draft Guidance does not include a data element for a Substitution Device Identifier (DI). The Substitution DI data element in the GUDID is imperative for the device labeler to comply fully with the UDI regulation, when it is applicable. At minimum, if the GUDID does not contain this data element, the guidance must address how device labelers shall comply with (b)(2), especially in the event of an acquisition or merger. These types of business arrangements occur quite regularly in the medical device industry and instruction must be provided to device labelers regarding transfer of GUDID submission data when labeling information has been converted to the purchasing company. Page 4 of 21

5 1.4. GUDID Required Data Elements and Ancillary Device Identification Information 21 CFR Information Required for Unique Device Identification states: The contact for device identification designated under (a) shall provide FDA with the following information concerning each version or model of a device required to bear a unique device identifier (UDI) on its label: (a) Concerning the labeler: (1) through (3) (b) Concerning each version or model of a device with a UDI on its label:...(1) through (14) However, there are data elements identified in Appendix B of the GUDID Draft Guidance that are identified as required data elements when in fact they are not required per as information device labelers must provide to FDA for GUDID submission data. Rather, FDA should identify these data elements as ancillary device identification information to be submitted voluntarily to the GUDID per CFR Voluntary Submission of Ancillary Device Identification Information states: (a) You may not submit any information to the Global Unique Device Identification Database (GUDID) other than that specified by , except where FDA acts to permit the submission of specified additional types of information, termed ancillary information.[emphasis added] (b) FDA will provide information through the FDA Web site at concerning the types of ancillary information that may be submitted to the GUDID. (c) FDA may periodically change the types of ancillary information that may be submitted to the GUDID. We will announce any change on the FDA Web site at at least 60 days before making the change. Data elements in the GUDID Draft Guidance which should be clarified as voluntary ancillary information instead of required data elements include: Support Contact Phone (p. 37) Support Contact (p.38) Product Code (p. 41) For Single Use (p. 42) Storage and Handling Type (p.48) Requires Sterilization Prior to Use (p. 50) Page 5 of 21

6 2. Clarification for Data Consistency and Accuracy Data quality is imperative for the GUDID to provide accurate information in the identification of medical devices and to serve its intended public health objectives. To obtain the level of data quality necessary to meet these objectives, further clarification is needed in the GUDID Draft Guidance. Modifications to the following would assist device labelers in providing more consistent and accurate data to the GUDID: 2.1. Edit Rules after Grace Period The Edit Rules after Grace Period statements in Appendix B of the GUDID Draft Guidance are not clear or complete and causes confusion to device labelers. The table below highlights some examples regarding how the Add, Edit and Delete rules have the potential to provide inconsistent interpretation. FDA statements in the GUDID Draft Guidance, Appendix B, Edit Rules after Grace Period: Interpretation of Edit Rules after the Grace Period Edit Rules after Grace Period Add Edit Delete Can edit after Grace Period? Yes? Can add or delete after Grace Period Yes? Yes Cannot edit after Grace Period? No? Cannot add or delete after Grace Period No? No Can add after Grace Period, but cannot delete. Yes? No Can add with new package configuration after Grace Period, but cannot delete. Yes? No To clarify the GUDID Draft Guidance, presenting the edit rules as three different actions would provide a much more clear and consistent interpretation among device labelers. Furthermore, the add/edit/delete rules after the grace period should be consistent with the trigger for a new DI. It is unclear why the GUDID does not allow for edits to data elements after the grace period if the data element does not trigger a new DI per The following examples include changes to data elements that do not trigger a new DI, but are listed in Appendix B of the GUDID Draft Guidance as not allowing edits to the GUDID after the grace period. Size Type, Size Value, Size Unit of Measure, and Size Type Text (p ) Example: A device labeler may change from US units of measure to metric units of measures without affecting the actual size of the device. This does not necessitate a change in version or model number or create a new device package per and should allow for editing after the grace period. Page 6 of 21

7 Device Exempt from Premarket Submission (p. 39) Example: A device may be up classified or down classified (exempt to 510(k) or vice versa) through regulation change. This does not necessitate a change in version or model number or create a new device package per and should allow for editing after the grace period. MRI Safety Status (p. 45) Example: A company may change the MRI safety status on the label from MR Conditional to MR Safe by providing additional testing to FDA through submission review and approval/clearance. This does not necessitate a change in version or model number or create a new device package per and should allow for editing after the grace period. Package Type (p.36) This data element is Private. A change to the package type does not necessitate a change in version or model number or create a new device package per and should allow for editing after the grace period System Populated Data Elements Appendix B of the GUDID Draft Guidance Data does not consistently link the system populated data elements with its dependent data elements. It is essential that device labelers understand what data elements are dependent on each other and what the system validation rules are to reduce the number of GUDID submission failures. Therefore, all data dependencies should be identified in the GUDID Draft Guidance. For the GMDN Name and Definition data elements, the data entry notes clearly identify that they are system populated based on the GMDN Code data element. However, the following data elements are examples of unclear data dependencies which should be consistently identified in the GUDID Draft Guidance: Company Name, Company Physical Address (p. 31) The data entry notes do not identify that these two data elements are linked to the Labeler DUNS Number data element. Commercial Distribution Status (p.33) The data entry note does not identify this data element as being linked to the Commercial Distribution End Date data element. Package Status (p. 37) The data entry note does not identify this data element as being linked to the Package Discontinue Date data element. Product Code Name (p. 41) The data entry note does not identify this data element as being linked to the Product Code data element. Page 7 of 21

8 2.3. FDA Premarket Submission Number and Supplement Number The data entry notes for the data elements FDA Premarket Submission Number and Supplement Number indicate to enter all valid FDA Premarket Submission Numbers. However, 21 CFR Information Required for Unique Device Identification states: The contact for device identification designated under (a) shall provide FDA with the following information concerning each version or model of a device required to bear a unique device identifier (UDI) on its label: (b)(11) The FDA premarket submission number of a cleared or approved device, or statement that FDA has by regulation exempted the device from premarket notification; [emphasis added] The requirement does not indicate multiple submission numbers, but rather one submission number. In addition, it is quite burdensome to the device labeler and to FDA to continually submit and receive updated DI records for additional premarket submission numbers that do not trigger the need for a new DI. For example, after a Class III product is in commercial distribution PMA supplements quite often include submissions to make manufacturing changes. It is unclear how the addition of these types of submissions would provide value to the GUDID, especially since they are available publicly in the PMA and 510(k) databases. Furthermore, entering the submission history for every DI record during the initial load of the GUDID will be quite burdensome with little, if any added value to the GUDID. It is important to note, for some DI records this could include years of submission numbers. Therefore, Boston Scientific strongly encourages a revision to the data entry notes for both the FDA Premarket Submission Number and Supplement Number data elements to state Enter the FDA premarket submission number or supplement number that put the DI into commercial distribution. This is least burdensome both for device labelers and FDA as well as consistent with (b)(11) FDA Listing Number Similar to the FDA Premarket Submission Number and Supplement Number data elements, the FDA Listing Number data element entry notes indicate to enter all applicable listing numbers. However, 21 CFR Information Required for Unique Device Identification states: The contact for device identification designated under (a) shall provide FDA with the following information concerning each version or model of a device required to bear a unique device identifier (UDI) on its label: Page 8 of 21

9 (b)(12) The FDA listing number assigned to the device; [emphasis added] The requirement does not indicate multiple listing numbers, but rather one listing number. In addition, it will be quite burdensome to the device labeler and unclear how this provides value to the GUDID; especially since this is already tracked in the publicly available FURLS database. Therefore, Boston Scientific strongly encourages a revision to the data entry notes for the Device Listing data element to state Enter the FDA listing number that put the DI into commercial distribution. This is more consistent with (b)(12) Production Identifiers 21 CFR Information Required for Unique Device Identification states: The contact for device identification designated under (a) shall provide FDA with the following information concerning each version or model of a device required to bear a unique device identifier (UDI) on its label: (b)(10)the type of production identifiers that appear on the label of the device; However, any number of the production identifiers may appear on a single label, but not all may be used for traceability of the product. As such, the intent of (b)(10) is to identify those production identifiers used for device traceability. This is consistent with the description of the data elements for production identifiers where the description states the production identifier is a flag to indicate the device is managed by [production identifier]. To further clarify this important distinction and to maintain data consistency and accuracy among device labelers this should be clarified in the Required? column for all production identifier data elements (e.g., Lot or Batch Number, Manufacturing Date, Serial Number, and Expiration Date) Product Code The GUDID Draft Guidance identifies in the data entry notes to Enter all applicable Product Codes. Further clarification and definition is necessary to obtain consistent and accurate data from device labelers. It is unclear which code(s) should be entered in the GUDID in the scenario where the PMA or 510(k) is approved or cleared for a system. In these situations more than one product code is often assigned to the submission. However, it is unclear if FDA is requesting the product code that matches the device identifier or for all product codes that are applied to the submission. Page 9 of 21

10 2.7. Size Type and Size Unit of Measure 21 CFR Information Required for Unique Device Identification states: The contact for device identification designated under (a) shall provide FDA with the following information concerning each version or model of a device required to bear a unique device identifier (UDI) on its label: (b)(9) If the device is available in more than one size, the size of the particular version or model, together with the unit of measure, as it appears on the label of the device; To be consistent with , Size Type and Size Unit of Measure should be clarified in Appendix B of the GUDID Draft Guidance in the Required? column to indicate these data elements are required if the size is provided on the label. This will also ensure that submissions to the GUDID are consistent and accurate among device labelers. In addition, the Entry List of Values (LOV) in the GUDID Draft Guidance for Size Type and Size Unit of Measure seem incomplete and confusing. Additional Entry List of Values for Size Type should include: Diameter, Inner Diameter, Outer Diameter, Weight, Frequency. In addition, French Catheter Gauge should be removed as this is not a size type but rather a unit of measure under diameter size type. Similarly, the Entry List of Values for Size Unit of Measure should combine the list of values for lengths and volume instead of separating them by category, as these units may be interchangeable given the Size Type data element selected. Furthermore, categories for Weight, Diameter, Frequency and Pressure seem to be missing. Values that should be added to this list include: Cubic Centimeter, French, Gauge, Gram, Kilogram, Pound, Kilohertz, Megahertz, Kilopascal, Pound per Square Inch, and Atmosphere. SPECIFIC COMMENTS Specific comments concerning detailed changes to the GUDID Draft Guidance are captured in table format and attached to this letter. CONCLUSION We appreciate this opportunity to review and provide our comments regarding Global Unique Device Identification Database (GUDID); Draft Guidance. We incorporate by reference expanded comments submitted by AdvaMed, of which Boston Scientific is a member. Company representatives are available to answer any questions FDA may have about our comments. We look forward to further collaboration on this important topic. Page 10 of 21

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12 Attachment: Specific Comments on the GUDID Draft Guidance GUDID Draft Guidance Page Number Data Element Change to Reason for the Change p. 31 Company Name Data Entry Notes: System populated based on Labeler DUNS Number. Further clarification necessary for data consistency and accuracy. Refer to Section 2.2 above. p. 31 Company Physical Address Description: Company physical address associated with the DUNS Number entered in the DI. This address should match the address on the device label. p. 31 Company Physical Address Data Entry Notes: System populated based on Labeler DUNS Number. This data element is private status and is not publicly available in the GUDID. Therefore, the physical address bears no need to match the address on the device label. Furthermore, the physical address on the label may not match what is in the DUNS database due to device labeler responsibilities and the system used at DUNS to maintain company addresses. Further clarification necessary for data consistency and accuracy. Refer to Section 2.2 above. Page 12 of 21

13 GUDID Draft Guidance Page Number Data Element Change to Reason for the Change p. 32 Brand Name Description: The Proprietary/Trade/Brand name of the medical device as used on the in device labeling or in the catalog. This information may 1) be on the label attached to a durable device, 2) or be on a package of a disposable device, or 3) appear in labeling materials of an implantable device. The brand name is the name that is typically registered with USPTO and have the and/or symbol. p. 32 Brand Name Edit Rules After Grace Period: Cannot edit after Grace Period p. 32 Brand Name Required?: Not Required. Required if there is a Brand Name on the label 21 CFR (b)(4) states the proprietary, trade, or brand name of the device as it appears on the label of the device; Refer to Section 1.2 above. 21 CFR (b)(4) states the proprietary, trade, or brand name of the device as it appears on the label of the device. If there is no brand name on the label this should not be a require data element. There are products that do not have Brand Names on the label. p. 32 Brand Name New DI Trigger?: YES NO Refer to Section 1.2 above. Page 13 of 21

14 GUDID Draft Guidance Page Number Data Element Change to Reason for the Change p. 32 Version or Model Number Description: The version or model number found on the device label or accompanying packaging used to identify a category or design of a device. The version or model means all devices that have specifications, performance, size, and composition, within limits set by labeler. p. 32 Version or Model Number Required?: Not Required. Required if there is a version or model number that appears on the label of the device. p. 32 Catalog Number Data Element: Catalog Reference/Catalog Number p. 32 Catalog Number Description: The catalog, reference, or product number found on the device label or accompanying packaging to identify a particular product. p. 32 Catalog Number Required?: Not Required. Required if there is a reference number that appears on the label of the device. Remove to be consistent with 21 CFR (b)(5). Reference Section 1.1 above. Add to be consistent with 21 CFR (b)(5). Refer to Section 1.1 above. Revise to be consistent with 21 CFR (b)(5) and ISO Medical Devices Symbols to be used with medical device labels, labeling and information to be supplied Part 1: General requirements Remove to be consistent with 21 CFR (b)(5). Refer to Section 1.1 above. Add to be consistent with 21 CFR (b)(5). Refer to Section 1.1 above. Page 14 of 21

15 GUDID Draft Guidance Page Number Data Element Change to Reason for the Change p. 33 Commercial Distribution Status Data Entry Notes: System populated based on Commercial Distribution End Date (mm/dd/yyyy). Further clarification necessary for data consistency and accuracy. Refer to Section 2.2 above. p. 35 Secondary DI Number Required?: Required if there is a Secondary DI Number on the label Clarify in the Required column that this field should only be entered if the label bears a secondary DI number. This is important to distinguish because secondary DI numbers may be utilized in other device labeler systems but may not be customer facing. p. 36 Contains DI Package New DI Trigger?: NO YES Revise to be consistent with 21 CFR (b). Refer to Section 1.2 above. p. 36 Package Type Edit Rules After Grace Period: Can add, edit or delete with new package configuration after Grace Period, but cannot delete or edit. p. 37 Package Status Data Entry Notes: System populated based on Package Discontinue Date. Revise to be consistent with 21 CFR Refer to Section 2.1 above. Further clarification necessary for data consistency and accuracy. Refer to Section 2.2 above. Page 15 of 21

16 GUDID Draft Guidance Page Number Data Element Change to Reason for the Change p. 37 Support Contact Phone Required?: Not Required. if support contact information is entered This information is not required per 21 CFR Refer to Section 1.4 above. p. 38 Support Contact Required?: Not Required. if support contact information is entered This information is not required per 21 CFR p. 39 Device Exempt from Premarket Submission Edit Rules After Grace Period: Cannot add, edit or delete after Grace Period, but cannot delete or edit. Refer to Section 1.4 above. Revise to be consistent with 21 CFR Refer to Section 2.1 above. p. 40 FDA Premarket Submission Number Data Entry Notes: Enter the all valid FDA Premarket Submission Numbers that put the DI into commercial distribution. p. 40 Supplement Number Data Entry Notes: Enter the all valid Supplement Numbers that put the DI into commercial distribution. Revise to be consistent with 21 CFR (b)(11). Refer to Section 2.3 above. Revise to be consistent with 21 CFR (b)(11). Refer to Section 2.3 above. p. 41 Product Code Required?: Not Required for all medical devices except for Kits or IVDs (BL premarket submission number) This information is not required per 21 CFR Refer to Section 1.4 above. Page 16 of 21

17 GUDID Draft Guidance Page Number Data Element Change to Reason for the Change p. 41 Product Code Data Entry Notes: Enter all applicable Product Codes that match the device identifier. Further clarification necessary for data consistency and accuracy. Refer to Section 2.6 above. p. 41 Product Code Name Data Entry Notes: System populated based on Product Code. Further clarification necessary for data consistency and accuracy. Refer to Section 2.2 above. p. 41 FDA Listing Number Data Entry Notes: Enter the FDA all applicable Listing Numbers that put the DI into commercial distribution. Revise to be consistent with 21 CFR (b)(12). Refer to Section 2.4 above. p. 42 For Single Use Description: Indicates that the device is intended for one use or on a single patient during a single procedure, regardless of if single use is stated on the label. Further clarification necessary to ensure consistent and accurate GUDID submissions. p. 42 For Single Use Required?: Not Required This information is not required per 21 CFR Refer to Section 1.4 above. p. 42 Lot or Batch Number Required?: Required. Required if Lot or Batch Number production identifier is on the label and used for device traceability purposes. Further clarification necessary for data consistency and accuracy. Refer to Section 2.5 above. Page 17 of 21

18 GUDID Draft Guidance Page Number Data Element Change to Reason for the Change p. 42 Manufacturing Date Required?: Required. Required if Manufacturing Date production identifier is on the label and used for device traceability purposes. p. 43 Serial Number Required?: Required. Required if Serial Number production identifier is on the label and used for device traceability purposes. p. 43 Expiration Date Required?: Required. Required if Expiration Date production identifier is on the label and used for device traceability purposes. Further clarification necessary for data consistency and accuracy. Refer to Section 2.5 above. Further clarification necessary for data consistency and accuracy. Refer to Section 2.5 above. Further clarification necessary for data consistency and accuracy. Refer to Section 2.5 above. p. 43 Device Required to be Labeled as Containing Natural Rubber Latex or Dry Natural Rubber (21 CFR ) New DI Trigger?: YES NO Refer to Section 1.2 above. p. 45 MRI Safety Status Edit Rules After Grace Period: Can add MRI Safety Status after Grace Period only if the field Has the device been evaluated for MRI Safety? was previously unchecked. Cannot edit after grace Period if Has the device been evaluated for MRI Safety? was previously checked. p. 46 Size Type Edit Rules After Grace Period: Can add or edit after Grace Period, but cannot delete or edit. MRI Safety Status should be able to be edited after the grace period. Refer to Section 2.1 above. Revise to be consistent with 21 CFR Refer to Section 2.1 above. Page 18 of 21

19 GUDID Draft Guidance Page Number Data Element Change to Reason for the Change p. 46 Size Type Required?: Not Required. Required if Size is provided on the label. Further clarification is necessary. Refer to Section 2.6 above. p. 46 Size Type Entry List of Values (LOV): Circumference; Depth; Device Size Text; Specify: French Catheter Gauge; Greatest Diameter: Height: Length; Lumen Diameter; Needle Gauge; Second Greatest Diameter; Total Volume; Width; Diameter, Inner Diameter; Outer Diameter; Weight; Frequency p. 47 Size Value Edit Rules After Grace Period: Can add or edit after Grace Period, but cannot delete or edit. Further clarification is necessary. Refer to Section 2.7 above. Revise to be consistent with 21 CFR Refer to Section 2.1 above. p. 47 Size Unit of Measure Edit Rules After Grace Period: Can add or edit after Grace Period, but cannot delete or edit. Revise to be consistent with 21 CFR Refer to Section 2.1 above. Page 19 of 21

20 GUDID Draft Guidance Page Number Data Element Change to Reason for the Change p. 47 Size Unit of Measure Entry List of Values (LOV): For Lengths: Centimeter; Cubic Inch; Decimeter; Feet; Femtometer; French; Inch; Kilometer; Meter; Microliter; Micrometer; Millimeter; Nanometer; Picometer; Pint; Square Centimeter; Square Feet; Square Inch; Square Meter; square Millimeter; Ton; Yard For Total Volume: Centiliter; Cup; Deciliter; Femtoliter; Fluid Ounce; Gallon; Kiloliter; Liter; Micrograms per Total Volume; Milligrams per Total Volume; Milligrams per Total Volume; Milliliter; Nanoliter; Picoliter: Quart; Units per Liter; Cubic Centimeter; French; Gauge; Gram; Kilogram; Pound; Kilohertz; Megahertz; Kilopascal; Pound per Square Inch; Atmosphere p. 47 Size Type Text Edit Rules After Grace Period: Can add or edit after Grace Period, but cannot delete or edit. Further clarification is necessary. Refer to Section 2.7 above. Revise to be consistent with 21 CFR Refer to Section 2.1 above. p. 48 Storage and Handling Type Required?: Not Required. Required if storage and Handling is provided. This information is not required per 21 CFR Refer to Section 1.4 above. Page 20 of 21

21 GUDID Draft Guidance Page Number Data Element Change to Reason for the Change p. 48 Low Value Required?: A Low Value and/or a High Value is required if Storage and Handling Type is provided in the GUDID. p. 49 High Value Required?: A Low Value and/or a High Value is required if Storage and Handling Type is provided in the GUDID. p. 49 Unit of Measure Required?: Required if Storage and Handling Type is provided in the GUDID. Further clarification is necessary. Refer to Section 1.4 above. Further clarification is necessary. Refer to Section 1.4 above. Further clarification is necessary. Refer to Section 1.4 above. p. 50 Requires Sterilization Prior to Use Required?: Not Required This information is not required per 21 CFR Refer to Section 1.4 above. Page 21 of 21