September 26, Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852

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701 Pennsylvania Avenue, NW Suite 800 Washington, D.C. 20004 2654 Tel: 202 783 8700 Fax: 202 783 8750 www.advamed.

1 701 Pennsylvania Avenue, NW Suite 800 Washington, D.C Tel: Fax: Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD Re: Docket No. FDA-2016-D-1853: Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI); Draft Guidance for Industry and Food and Drug Administration Staff To Whom It May Concern: The Advanced Medical Technology Association ( AdvaMed ) appreciates the opportunity to provide comment on the Food and Drug Administration s ( FDA or Agency ) Draft Guidance for Industry and Food and Drug Administration Staff: Unique Device Identification System: Form and Content of the Unique Device Identifier ( UDI ) ( Draft Guidance ). 1 AdvaMed represents manufacturers of medical devices, diagnostic products, and health information systems that are transforming health care through earlier disease detection, less invasive procedures, and more effective treatment. Our members range from the smallest to the largest medical technology innovators and companies. AdvaMed appreciates the Agency s interest in providing guidance and further clarity regarding the form and content of a device s UDI. However, we do not agree that data delimiters are a component of a device s UDI that must be included in the easily readable plain-text form. FDA s rules specifically define a UDI to be composed of a device identifier ( DI ) and production identifier ( PI ). 21 C.F.R Data delimiters are not mentioned in the Agency s rules, nor are they contemplated in the Preamble to the Federal Register Notice announcing the rule. See 78 Fed. Reg (Sep. 24, 2013). Requiring the inclusion of data delimiters may ultimately confuse, rather than aid, individuals who review the device s UDI. Many individuals within the healthcare system, and in particular patients who receive a device (including those sold over-the-counter), are unlikely to understand the purpose and meaning of the data delimiters. To understand their use, individuals would need to be educated on the relevant issuing agency s coding system. Moreover, we recommend FDA allow manufacturers to use symbols in place of or in combination with data delimiters for the easily readable plain-text version of the UDI. Symbols associated with the specific string of information related to UDI capture technology 1 Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI); Draft Guidance for Industry and Food and Drug Administration Staff (July 26, 2016), available at pdf. Bringing innovation to patient care worldwide

2 Docket No. FDA-2016-D-1853 Page 2 of 3 ensure unambiguous interpretation of the information encoded within the UDI system. We also believe that using symbols will make it much easier for individuals who do not have knowledge of data issuing agency coding systems to understand the labeling. For example, we believe Label 1 below is easier to understand than Label 2. Label 1 Label 2 Lastly, many manufacturers do not currently include data delimiters in their easily readable plain-text due to the fact that this is not required by the Agency s UDI rules. To require manufacturers to include data delimiters in their easily readable plain-text at this time could disrupt established UDI processes. To address these concerns, we recommend revising the definition of Easily readable plaintext within the Draft Guidance, and any resulting references, to: The human-legible interpretation of the data characters encoded in the AIDC form of the full UDI, including the data delimiters and/or symbols. We also believe that Section E ( Order of the data represented in the UDI carrier ) should be removed from the Draft Guidance. The UDI rule does not prescribe an order for UDI and non-udi elements in the UDI carrier. This issue is best left to the relevant issuing agencies. Moreover, FDA has stated that it would not regulate [t]he order in which specific information is communicated by AIDC. See Comments on the Proposed Rule and FDA s Responses, Formatting of Dates Provided on Medical Device Labels ( FDA agrees that we should not attempt to regulate how data is communicated by AIDC technologies, or the order in which specific information is communicated by AIDC. ). 78 Fed. Reg. at

3 Docket No. FDA-2016-D-1853 Page 3 of 3 It may also be advantageous to place data elements with a variable length at the end of the barcode, in contrast to fixed length data elements. Data elements with a variable length (such as lot number or serial number) are followed by a Stop to signal the end of the element. This is not needed for fixed-length data elements (such as expiration date). Moreover, FDA does not provide a rationale for specifying this sequence. We also note that this section would render many existing UDIs non-compliant, and many existing FDA examples of UDIs on its website would be incorrect as well. Additional, detailed comments with respect to the content of the Draft Guidance can be found in the attached document. * * * AdvaMed would like to thank the FDA for its consideration of these comments. Please do not hesitate to contact me at or zrothstein@advamed.org if you have any questions. Respectfully submitted, /s/ Zachary A. Rothstein, Esq. Associate Vice President Technology and Regulatory Affairs Attachment

4 Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) 1 General We recommend FDA add to the Draft Guidance information on direct part marking and convenience kits requirements We recommend including the following regarding software: In some cases, different requirements may apply to device labeling than to device direct part marking. Currently, the Draft Guidance does not distinguish between the two. For example, lines only apply to AIDC technology; however, the non-hri may also need to be split into multiple segments due to space limitations or other reasons. We believe this clarification will be useful to labelers. The UDI for stand-alone software may be provided through either or both of the following: easily readable plain-text statement displayed whenever the software is started; or easily readable plain text statement displayed through a menu command (e.g., an about command) (21 CFR ) We recommend revising the definition of data delimiter as follows: Within an encoded data string the UDI, a defined character or set of characters that identifies specific data elements pursuant to an Issuing Agency s structure and standards, if applicable We recommend the following addition: (a) The lot or batch within which a device (including software as a medical device) was manufactured We believe reference to within an encoded data string should be removed because data delimiters (or data labels) may be used in direct marking where there is no associated encoded data string or AIDC. Data delimiters are encoded issuing agency data carriers that must be used according to the Issuing Agency s standard structure and format. This reference should be included within the definition of data delimiter to clarify this point. We also recommend the draft guidance state that data delimiters may also be referred to as application identifiers. This phrasing is consistent with the UDI data elements for Lot/Batch ; ; 291 We recommend the following revised definition for UDI: A unique device identifier is composed of a device identifier (DI) and any applicable production identifiers (PIs). The FDA s UDI rule does not designate or mention data delimiters as a component of the UDI We recommend FDA replace the proposed definition of UDI carrier with the definition used in the December 9, 2013 IMDRF FDA should utilize the existing IMDRF definition of UDI carrier to ensure a consistent global definition and further align FDA s

5 Docket No. FDA-2016-D-1853: Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) Final UDI Guidance at p. 9: UDI Carrier The UDI Carrier is the means to convey the UDI by using AIDC and, if applicable, its HRI. Note: Carriers can include ID/linear bar code, 2D/Matrix bar code, RFID, etc definition with the Issuing Agencies definitions and guidance for use of human readable interpretation ; 218 We recommend adding the following information: We believe this clarification will be useful to labelers. The UDI for stand-alone software may be provided through either or both of the following: easily readable plain-text statement displayed whenever the software is started; or easily readable plain text statement displayed through a menu command We recommend deleting the following sentence: The AIDC form of UDIs should be scanned or otherwise used for the identification of the device whenever possible to minimize errors in records resulting from manual transcriptions We recommend deleting the following sentence: Additionally, the DI bar code should precede the PI bar code. This statement addresses end users. We do not believe it is appropriate for this Draft Guidance to direct end users on their use of UDI. This statement is not clear. Moreover, when linear bar codes are stacked, the placement of the data of the top or bottom bar code may be dependent upon the package size and scanning environment. While the majority of small packages carry the DI in the top bar code, Healthcare Distribution Alliance (HDA) and other distributors recommend the DI not be placed in the bottom bar code. Below is an example from the HDA Guide for large packages: 2

6 Docket No. FDA-2016-D-1853: Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) We recommend deleting the following sentence: Revise to: In this instance, only one easily readable plain-text form of the UDI should be on the label and should be in near proximity to one of the AIDC forms of the UDI. This sentence attempts to address specific barcode format guidance that is prescribed by (and could conflict with) issuing agency specifications. N/A If a labeler chooses choses We recommend deleting this paragraph. FDA should only require that the AIDC portion of the label be successfully read by AIDC capture devices; testing and other related issues should be left to the UDI issuing agencies. Moreover, this paragraph seems to shift the UDI rule away from a technology-neutral posture We recommend adding the following phrase: We believe these additions will help clarify the Draft Guidance. While some of the FDA-accredited issuing agencies may allow for non-udi elements, such as quantity, in the UDI carrier, we do not recognize any such additional non-udi elements as being part of the UDI, even if they are present in the AIDC or HRI. 3

7 Docket No. FDA-2016-D-1853: Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) We also recommend adding an example, such as the following: Yellow = UDI Red = non-udi elements Entire string = UDI carrier. (01) (21)12345(91) We suggest deleting the following sentence: However, it is important to note that for other than class I devices, if one or more of the five PIs defined under 21 CFR are included on a device label, the UDI must include each of the PIs that appears on the label (21 CFR (b)) We recommend mentioning that UPCs may not, and are not required to, include data limiters in the HRI We recommend revising this sentence as follows: The approved data delimiters FDA recognizes can be found in the UDI Formats by FDA-Accredited Issuing Agency document on the UDI webpage ( There are instances when one of the five FDA-recognized production identifiers (PI) are not used for UDI purposes, such as date of manufacture. The Draft Guidance should clearly state that only those PIs used for UDI purposes should be included in the UDI. For retail/consumer facing products, these pieces of information will be more confusing and will hinder the usefulness of the UDI. The information in the referenced document is not an exhaustive list of data delimiters prescribed by issuing agencies. The use of nonencoded data delimiters (or data titles) when there is no associated barcode (for direct markings) may significantly improve patient or provider readability and eliminate confusion and issues with capturing the UDI. We do not believe the Draft Guidance intends to limit the use of useful delimiters Replace easily readable plain-text with non-hri. The UDI rule does not identify data delimiters as a component of the UDI. 4

In addition, below we offer our responses to the questions posed in the Federal Register Notice announcing the availability of the Draft Guidance:

In addition, below we offer our responses to the questions posed in the Federal Register Notice announcing the availability of the Draft Guidance: 701 Pennsylvania Avenue, NW Suite 800 Washington, D.C. 20004 2654 Tel: 202 783 8700 Fax: 202 783 8750 www.advamed.org September 24, 2015 Division of Dockets Management (HFA305) Food and Drug Administration