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 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Re: Docket No. FDA-2015-D-2245-0001: Unique Device Identification: Direct Marking of Devices; Draft Guidance for Industry and Food and Drug Administration Staff To Whom It May Concern: The Advanced Medical Technology Association ( AdvaMed ) appreciates the opportunity to provide comments in response to the Food and Drug Administration s ( FDA ) Draft Guidance: Unique Device Identification: Direct Marking of Devices ( Draft Guidance ). 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 FDA s desire to bring needed clarity to this subject and is pleased that FDA has released, for public comment, this Draft Guidance. We believe it is essential that FDA clarify how devices should comply with the direct marking requirements of the unique identification ( UDI ) rule. 21 C.F.R. 801.45. While we believe the Draft Guidance provides clarity on a number of direct marking questions, the attached chart provides our specific comments to the Draft Guidance. We highlight our comment concerning 21 C.F.R. 801.30(a)(1), which provides that a finished device manufactured and labeled prior to its compliance date is excepted from UDI labeling requirements until three years after the UDI compliance date for that particular device. We urge FDA to clarify that, in the context of the Draft Guidance, the grace period established under this rule is based on the compliance date for when the device was first required to bear a direct mark, as opposed to when the device was first required to display a UDI on its label. In addition, below we offer our responses to the questions posed in the Federal Register Notice announcing the availability of the Draft Guidance: Bringing innovation to patient care worldwide
Docket No. FDA-2015-D-2245-0001 September 24, 2015 Page 2 of 2 1. FDA is concerned that devices intended to be used more than once tend to be separated from its original label during reprocessing, making accurate identification of devices difficult or impossible. Should the definition of reprocessing for purposes of UDI direct marking requirements include cleaning alone without subsequent disinfection and/or sterilization of the device? AdvaMed agrees with FDA s draft guidance, which states: For purposes of UDI direct marking requirements, we consider a device that is intended to be cleaned and either sterilized or disinfected before each use to be intended to be reprocessed. If a device is intended only to be cleaned between uses by different patients, this would not be considered reprocessing. 2. What public health benefits would be served by requiring a UDI direct marking to be affixed to devices intended to be reused for which reprocessing instructions include cleaning only and not disinfection and/or sterilization? There are no additional public health benefits that would be served by requiring a UDI direct marking to be affixed to a device intended to be reused for which reprocessing instructions include cleaning only and not disinfection and/or sterilization. * * * AdvaMed would like to thank the FDA for its consideration of these comments. Please do not hesitate to contact me at 202-434-7224 or zrothstein@advamed.org if you have any questions. Respectfully submitted, /s/ Zachary A. Rothstein Associate Vice President Technology and Regulatory Affairs Attachment
Date: September 24, 2015 AdvaMed Comment Form Document Title: Unique Device Identification: Direct Marking of Devices; Draft Guidance for Industry and Food and Drug Administration Staff Submitters Name: Zachary A. Rothstein Company: AdvaMed # Location Type Proposed Change Comment: Rationale/Justification for Change 1 Pg. 5 Section III Line 165 We recommend adding a question that addresses the applicability of direct part marking to IVD instruments. While IVD instruments, including meters, are intended to be used more than once, most are not intended to be either sterilized or disinfected before each use as described by this guidance. These instruments follow a routine maintenance schedule, which includes daily cleaning, but their labeling does not require the user to either sterilize or disinfect the instruments or meters before each use. 2 Pg. 6 Section III.A.4 Lines 198-207 Under 21 CFR 801.30(a)(1), a finished device manufactured and labeled, and still in the manufacturer s controlled inventory, prior to its compliance date for 21 CFR 801.20 is excepted from UDI labeling requirements until three years after the UDI compliance date for 21 CFR 801.20 for that particular device. Because direct marking requirements and data submission requirements are tied to the UDI labeling requirement at 21 CFR 801.20, the exception of 21 CFR 801.30(a)(1) applies to these requirements as well. For example, the compliance date for 21 CFR 801.20 for class III devices was September 24, 2014, and the compliance date for 21 CFR 801.45 for class III devices is September 24, 2016. Thus, an individual Class III device requiring direct marking that was manufactured and labeled on May 1, 2014, would not be required to be in compliance with UDI labeling, direct marking, or GUDID data submission requirements until September 24, 2017 and would not be required to be incompliance with UDI direct marking requirements until September 24, 2019. The provision currently identifies products affected by the rule by manufacturing and labeling dates. It is silent with respect to sold inventory in the possession of customers as well as consignment inventory. The intent of the three year grace period as described in the preamble to the Final UDI Rule is to allow for existing inventory (not yet in commercial distribution) manufactured prior to the applicable implementation date to be utilized. This grace period was established to prevent significant cost and product shortages. 21 C.F.R. 801.30(a)(1) expires with regard to a particular device three years after the compliance date established by FDA for the device. The compliance date established by FDA for direct marking of class III devices is September 24, 2016. Therefore, the three year exception for finished devices manufactured and labeled prior to the compliance date should be based on when the direct mark was first required, not when the device was first required to have a UDI on its label. This interpretation is also consistent with the original intent of the three year grace period. Applying a UDI to a product s label, or directly marking the UDI on the device, would occur at different points during the device s manufacturing process. It is much more burdensome for a manufacturer to rework inventory to apply a direct mark than it is to relabel a device package. 3 Pg. 7 Section III.A.5 Lines 211-213 We expect the permanent UDI to comply with the requirements of 21 C.F.R. 801.45(b) and (c) and last throughout the Manufacturers can only be responsible for the durability of the marking when recommended reprocessing steps are followed.
# Location Type Proposed Change Comment: Rationale/Justification for Change 4 5 6 7 8 Pg. 7 Section III.A.5 Lines 213-215 Pg. 8 Section III.A.8 Lines 282-283 Pg 8 Section 8 Lines 283-84 Pg. 9 Section III.A.9 Lines 301-306 Pg. 9 Section III.A.9 Lines 306-308 expected use life of the device, taking into account expected usage and reprocessing according to the instructions of the manufacturer. Possible methods to directly mark a device with a UDI include etching, attaching a permanent plaque to durable equipment, or affixing a durable label or permanent tag such as a radio frequency identification (RFID) tag to the device. If a product requires a direct marking and the DI and the DM- DI are the same, no additional information needs to be submitted to GUDID. We recommend FDA either: (1) Revise the design of the GUDID to allow: (a) duplication of DM-DI across different primary DIs; or (b) more than one DM-DI to a Primary DI; or (2) Provide an exception to the requirement that if the DI and the DM-DI are different, the labeler must submit the DM-DI when the DM-DI has been used in another device package, or when the device package contains more than one product that requires a direct mark. Rather, the labeler should maintain records for each DI with its associated range of PIs. The records should be regularly updated to reflect additional PIs associated with each DI. If your device falls within one of the exceptions from direct marking under 21 CFR 801.45(d) and you decide to make use of such, you are required to keep records supporting this decision in the design history file (see 21 C.F.R. 801.45(e)). If you determine any type of direct marking would interfere with the safety and effectiveness of the device (21 CFR 801.45(d) (1)), we expect the rationale that supports your 2 FDA should clarify that an affixed durable label can be used to direct mark a device as long as it lasts throughout the expected use life of the device, taking into account expected usage and reprocessing. This change will help clarify the sentence. The GUDID presents two problems to comply with this requirement: The first situation is where a device package has more than one product requiring a direct mark. The GUDID will not allow entry of more than one DM-DI for each Primary DI. The second situation is when a manufacturer produces a product that is packaged and commercialized in various device configurations under different Primary DIs. The GUDID will not allow duplication of DM-DI across the different Primary DIs. Although FDA does not expect records to list UDIs (DI and PI) separately, the Device History Record (DHR), as required under 21 C.F.R. 820.184, already contains DI and PI information and should be identified as a means to meet this requirement. The guidance suggests that a separate record should be established by stating a need for regular updates and additional PIs. We recommend making the statement more generic to allow the DHR to satisfy the record keeping requirements of 21 C.F.R. 830.360. This section currently only directs the documentation that marking a specific item is not technically feasible to be entered into the design history file. There should also be a uniform place for documenting testing/rationale for the safety and efficacy of the device when directly marked.
# Location Type Proposed Change Comment: Rationale/Justification for Change 9 10 11 12 13 Pg. 10 Section III.B.3 Line 343 Pg. 10 Section III.B.3 Line 343 Pg. 11 Section III.C.2 Line 380-383 Pg. 11 Section III.C.2 Line 383-385 Pg. 11 Section III.D.1 Line 396 decision to be scientifically justified by analysis and/or testing. This rationale and support should be documented in the design history file. We recommend FDA remove the link to its UDI Formats document. If FDA wishes to provide a link to an outside resource for additional information, we recommend only linking directly to the issuing agencies. If, however, FDA determines to maintain the link to the UDI Formats document, the agency should edit the document to address ambiguities and, in some cases discrepancies, with guidance issued by the various issuing agencies. We recommend clarifying that inclusion of data delimiters in the HRI data string should be based on the issuing agency s guidance. For purposes of UDI direct marking requirements, we consider a device that is intended to be cleaned and either sterilized or disinfected before each use to be intended to be reprocessed. If a device is intended only to be cleaned between uses by different patients, this would not be considered reprocessing for the purposes of the UDI direct marking requirements. FDA should also state that: Cleaning a product alone is not considered reprocessing, and therefore the device is not subject to direct marking. Disinfection and/or sterilization is conducted by validated methods and indicated by the product s intended use. We suggest moving the following sentence to section C.1: If the device is intended to be used more than once on or by the same patient, and not on or by different patients, the device does not need to be directly marked with a UDI. We recommend clarifying what is meant by not technologically feasible. In addition, examples and/or a decision tree would aid industry in making clear and consistent determinations for such exemptions. 3 The UDI Formats document provides information that may currently (or in the future) directly conflict with the specifications of the various issuing agencies. As currently drafted, the UDI Formats document includes information that is confusing and, in some cases, may contradict specifications of an issuing agency. FDA does not specifically state whether data delimiters must be readable on the label. FDA should defer such decisions to the issuing agencies. These changes will help clarify the Draft Guidance. For example, the Draft Guidance is unclear as to whether an alcohol wipe would be considered a cleaning product or a cleaning/disinfecting product prior to use on a different patient. It is confusing to have the statement about multiple uses included with question about, What does FDA consider reprocessed. We feel a more logical flow would be to place this text in section C.1, which clarifies multi-patient use. Very small parts and parts with complex and irregular surfaces present significant challenges to implement clear and consistent application of UDI markings. Clarifying FDA s expectations for the level of decision making and evidence a labeler must conduct to support an exception for
# Location Type Proposed Change Comment: Rationale/Justification for Change 14 15 Pg 12 Section III.D.2 Lines 427-430 Pg 12 Section III.D.2 Lines 427-430 We recommend revising this section to address the challenges of adding direct markings to legacy, post-production products. Reusable and reprocessed medical devices that require a UDI may already contain etched information that supports patient safety or indicates compliance with other regulations. We believe clinically relevant use information should take precedence over UDI information when space is limited. As a result, we recommend FDA create a list of markings that are considered to take precedence over UDI information when a device has limited space. Such items that should be included in the list are: CE mark; For Rx Only designation; catalog code/reference number; lot number/batch number; expiration date; product orientation for use; and product name. technological non-feasibility would be helpful. Such guidance could be in the form of examples, questions, or a flowchart. Adding direct marks to legacy, post-production products presents unique challenges because they are already marked with a variety of information, some commercial and some mandated by the QSR and regulatory requirements in other countries. It may not be technologically feasible to remove and reposition existing markings to fit the UDI, and it may be detrimental to the product to remove or reposition existing markings to fit the UDI. Further, removal of markings on legacy products may render the product in violation of regulations in other countries and create a significant burden for manufacturers. Below are two examples of etched marks that provide clinically relevant information, which we believe would provide an exception for safety and effectiveness: A currently marketed device that is sold globally has etchings for a catalog code and CE mark. There is no additional space to add a full UDI (DI + PI). In this situation, it would not be expected that the manufacturer would remove the catalog and CE mark to place a UDI on the device. A currently marketed device for implant has size and orientation (e.g., right, left) etched on the device. There is no additional space to add a full UDI (DI+PI). In this situation, it would not be expected that the manufacturer would remove the size and orientation information to directly mark a UDI on the device. 4