1300 North 17 th Street Suite 1752 Arlington, Virginia 22209 Tel: 703.841.3200 Fax: 703.841.3392 www.medicalimaging.org October 26, 2012 Margaret A. Hamburg, MD Commissioner Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 RE: Unique Device Identification System (FDA-2011-N-0090) Dear Commissioner Hamburg: This letter represents the comments of the Medical Imaging & Technology Alliance (MITA) in response to the U.S. Food and Drug Administration s (FDA) Proposed Rule to establish a Unique Device Identification (UDI) System 1. This rule will implement the requirement added to the Federal Food, Drug, and Cosmetic Act (FDC Act) by section 226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which directs FDA to promulgate regulations establishing a UDI system for medical devices. This rule is intended to substantially reduce existing obstacles to the adequate identification of medical devices used in the United States. MITA applauds FDA s efforts to implement this important regulation. However, we are concerned that the proposed rule raises a number of questions and concerns that should be addressed before the rule is finalized. MITA has set forth its comments and recommendations for revisions to this important rule below. We appreciate the opportunity to share our views with the Agency. MITA is the collective voice of medical imaging equipment manufacturers, innovators, and product developers, which include the following medical imaging technologies: medical x-ray equipment computed tomography (CT) equipment Molecular imaging equipment and radiopharmaceuticals radiation therapy equipment 1 77 Federal Register 40736 (July 10, 2012) 1
ultrasound equipment magnetic resonance imaging (MRI) equipment imaging information systems MITA Responses to FDA Questions FDA has posed a number of specific questions that may affect requirements of the final UDI rule. FDA s questions, followed by MITA s comments related to each question, are provided below. Objectives of the UDI System and Potential Uses of UDIs 1. Which of the objectives and potential uses identified for the UDI system are most important to you? Are there any important objectives or uses we have not identified or have not adequately discussed? If you consider any objective or use identified here inappropriate, unimportant, or unconvincing, please identify the objective or use and explain your views. MITA is concerned that the implementation of the UDI rule will be overly burdensome for device manufacturers. The implementation of the proposed system, consisting of a unique identifier mapped to a database such as Global Unique Device Identification Database (GUDID), has worldwide implications for the supply chain and will require coordination between device manufacturers and their outsourced thirdparty logistics providers (e.g., UPS, FEDEX) if the objectives of UDI are to be achieved. Furthermore, it is unclear how FDA envisions that the objectives of the UDI system will be accomplished. For example, FDA has not explained how the implementation of UDI can help to detect counterfeit devices. While it is not a statutory requirement to report actual product identifiers to the GUDID, if there is a requirement to take into account anti-counterfeit measures, then device manufacturers will have to implement and capture actual product identifiers during manufacturing. Hence, the burden is not about whether reporting is mandatory. What matters most when implementing the UDI system are the objectives and number of measures that are mandated on the industry. To achieve the unambiguous identification of medical devices throughout their lifecycle to detect counterfeiting, insofar as device traceability and improved post-market surveillance objectives are to be achieved, MITA is concerned that a tracking and tracing system will be required. Without industry tracking throughout the supply chain, there can be no traceability. It is not clear how these can be implemented with minimal burden on the supply chain, including medical device industry and their outsourced third-party logistics providers. MITA is further concerned that no timeframe has been given for the incorporation of UDI tracking into logistics systems to enable quicker and more accurate tracking and tracing of medical devices in the United States. MITA also would appreciate clarification as to whether there is an expectation that the UDI will be required on reimbursement claims. MITA understands that while the benefits of the UDI system imply the operational use of UDIs in computerized physician order entry (CPOE) and device checking prior to use, the proposed rule does not require this use; rather it merely provides the infrastructure to accomplish this goal. To achieve the benefit of a reduction in device-related medical errors, a standardized database is required. MITA would appreciate clarification from FDA on the design, layout, and deployment of this database to better understand how its clinical benefit can be realized. 2
Implementation of the UDI System Effective Dates 2. Do the proposed effective dates provide adequate time to prepare to meet the rule s requirements? If you believe a particular effective date does not provide adequate time to prepare to meet one or more of the rule s requirements, please identify the requirement, provide an explanation of the difficulties you foresee in meeting the requirement, and provide a suggested effective date that would provide adequate time to prepare to meet the requirement. The proposed effective date for the requirement to provide dates on medical devices that conform to a specific format, is 1 year after the publication of the final rule. Not all device labels would require date format changes. MITA is concerned that the proposed effective dates do not provide adequate time for manufacturers to prepare to meet the UDI rule requirements, as device manufacturers will need to consult with FDA or FDA-accredited issuing agencies and implement an appropriate system operated by that agency in order to issue UDIs for their products. The time that will be required for prospective issuing agencies to submit their applications for accreditation to FDA and for FDA to review these materials and accredit these agencies will delay the time when manufacturers can begin discussions with potential issuing agencies. As issuing agencies will not begin their accreditation process until after the final rule is published, MITA believes that companies could face substantial delays in the initial implementation of a UDI system. MITA agrees with a risk-based approach to implementation of the UDI rule; however, we are concerned that one year is insufficient for the implementation of the rule for class III devices. This will require companies to develop new infrastructure, evaluate proposed systems and vendors, develop new specifications, validate those specifications, and train employees, among other things. The validation and verification of new printing and scanning equipment and software alone may take months. A one-year implementation requirement for class III devices would result in a significant disruption to manufacturing activities, which may adversely impact the availability of critical medical devices in the United States. MITA believes it would be more efficient, cost-effective, and in the interest of the public health to add 24 months to the proposed implementation timeline for both class II and class III devices. 3. Will the 1-year effective date result less efficient planning as compared to a later date? Taking into account the effective dates for the other requirements of the proposed rule, what should be the effective date for the formatted date requirement and why? MITA is concerned that a one year is not sufficient time for manufacturers to implement the formatted date requirement of the UDI rule for all products. In addition, such a requirement would result in inefficiencies, because it would require manufacturers to modify their device labeling twice in order to comply with the requirements of the rule once to meet the formatted date requirements and again to implement the UDI label. MITA believes that the effective dates of proposed 801.18 should be the same as the effective date of the UDI rule for the specific device class. As above, MITA proposes that the effective date of the formatted date and display of a UDI label be three years from publication of a final rule for both class II and class III devices. 3
UDI Labeling Requirements 4. Is the requirement for a plain-text UDI clear? If you believe the requirement for a plain-text UDI would require changes to your labeling processes that are substantially different from those required for other types of labeling changes that you routinely make, please describe the changes you would have to make and provide an estimate of the cost of those changes. MITA believes that this requirement is clear. MITA also believes, however, that it will result in changes to the labeling processes currently used by its members, because new equipment likely will be required to implement these requirements. 5. Is the requirement for an AIDC technology clear? What type of AIDC technology do you expect to use? If you believe the requirement for AIDC would require changes to your manufacturing, labeling, or packaging processes that are substantially different from those required for other types of labeling changes that you routinely make, please describe the changes you would have to make and provide an estimate of the cost of those changes. MITA is concerned that the requirement to use automated identification and data capture (AIDC) technology could create labelling difficulties for companies that currently use AIDC technology in their products. Furthermore, if a company currently employs AIDC technology for device tracking, implementation of the UDI rule may require changes to that AIDC format that could be prohibitively expensive. Finally, at present it is unclear whether the formatted date requirements will require a change in the format of a company s AIDC application identifier. Direct Marking 14. The proposed rule would require direct marking of stand-alone software devices, but does not define standalone software. The exception provided by proposed 801.50(e)(6) makes it clear that stand-alone software does not include software that is a component of a medical device. Because the term component has been in common use for many years, FDA believes that the medical device industry has an adequate understanding of when software is stand-alone software that is itself a medical device and when software is only a component of a medical device. Does the component distinction provide enough clarity for you to understand when software is standalone software that requires direct marking? If not, please suggest how FDA could define stand-alone software so that it would be clear when software must be directly marked. While MITA agrees that the definition of stand-alone software is clear, we are concerned that there is a gray area around unlockable features and software upgrades. For example, sometimes software that is installed on a device may be able to be used separately from the device to provide diagnostic interpretation. This may be an additional module or an intrinsic part of the software that can be unlocked by a license key. MITA would appreciate clarification regarding whether such software would be considered by FDA to be stand-alone software for the purposes of the UDI rule. MITA would also appreciate clarification regarding the circumstances under which system software upgrades that may alter or update the function of the device would require a change to the device UDI. For example, if a device has embedded software that is considered a component of the device, and that software is installed or upgraded by the customer, what is the impact on the UDI requirements? Is a separate UDI required for the media (e.g., CD) and for the package? Is such software required to display 4
the UDI information via an information screen similar to the screen that displays the product PN and Version? If the same software is installed only by a company technician, do the requirements differ? MITA urges FDA to consider these situations in developing the final rule and any guidance developed thereafter. Form of a Unique Device Identifier 21. Should FDA require the use of specific AIDC technologies or have a role in approving the use of new AIDC technologies that are used to provide a UDI, or should we leave this decision to the healthcare community and issuing agencies? MITA believes that this decision should be left to the discretion of the device manufacturer; however, MITA would appreciate clarification from FDA regarding whether the agency will approve particular technologies, such as active radio-frequency identification (RFID), as being suitable for use in a hospital environment. 22. We propose to permit use of a generic symbol to provide notice of the presence of AIDC technology that provides a UDI: Should we restrict this provision to allow use of the generic symbol only when there is no symbol endorsed in an international standard, and no symbol generally recognized by the persons who typically use the device? For example, there are recognized symbols for RFID and NFC technologies; should we require use of one of those recognized symbols when that form of AIDC technology is used? MITA is concerned that the requirement for manufacturers to include a symbol, such as that included in the proposed rule, in cases where the AIDC technology is not evident upon visual examination of the label or package may be unduly burdensome in situations where manufacturers choose to adopt RFID technology due to the restricted size of the device or label. In addition, MITA is concerned that if companies choose to apply RFID, they must also employ data matrix barcodes, or something similar, which would be unduly burdensome. Roles of the Issuing Agency 24. Will the existence of multiple UDI systems confuse device user facilities or impose unreasonable costs on device user facilities? MITA believes that multiple permutations of a single system would be a preferable to multiple UDI systems, but as long as the AIDC s are compatible, then differences such as device identifier length and composition can be reasonably addressed. 5
Data Submission Requirements and the GUDID 27. If you believe any of the information that would be required by proposed 830.330 is not necessary to assure the adequate identification of a medical device, please identify the information you believe is unnecessary and provide an explanation of your views. MITA does not believe that the following information is necessary to adequately identify the device: Any version or model number or similar reference that appears on the label of the device (proposed 830.310(b)(5)); The Global Medical Device Nomenclature (GMDN) code for the device (proposed 830.310(b)(12)). 28. If you believe that additional information should be required to assure the adequate identification of a medical device, please identify the information you believe is necessary and provide an explanation of your views. MITA does not believe any of the additional suggested attributes listed in the Federal Register notice, nor other additional information, is necessary to assure adequate identification of medical devices. In particular, MITA does not believe that MRI compatibility type is a necessary additional attribute, as this information is typically provided in device labeling already. 29. If you believe that it is unreasonable to tie submission of UDI data to the date the label of the device must bear a UDI, please suggest an alternative time frame and provide an explanation of why the delay in submission of information is necessary. MITA believes that it is reasonable to tie submission of the UDI data to the date that the device label must bear a UDI label; however, MITA believes that this date should be an additional 24 months from the implementation date in the proposed rule for both class II and class III devices. For changes to the submitted data, MITA believes labelers should be given 10 days from the date that the device is first labeled with the changed information to update the GUDID, as is proposed to be the case when labeling is unaffected by such changes. This is necessary because the collection or generation of these data and their transmission are time consuming and complex tasks. A 10-day timeframe would provide a reasonable period for the introduction of new operating procedures for the production, storage, and transmission of this data. 31. What information would FDA need to provide in its guidance on submitting data to the GUDID? What questions would you want to see asked and answered in the guidance? MITA urges FDA to develop guidance on the UDI system in a timely fashion once the rule is finalized. MITA believes FDA s GUDID guidance should, among other things, address the following questions and concerns: MITA believes that the GUDID database should be flexible enough to account for a device that is covered by more than one 510(k) notice. What is the nature of the GUDID? Is it truly a single worldwide database? If so, which regulatory agency will be responsible for managing the database? If not, is it a series of linked 6
databases containing the same data-set for all medical devices that will be regulated locally by regulatory bodies? Is the GUDID intended to supplant the Global Data Synchronization Network (GDSN) or supplement it? Manufacturers should not be penalized if FDA suspends the accreditation of an issuing agency. The issuing agency is not under the control of the manufacturer, and there could be significant consequences to the labeler or manufacturer if FDA removes the device identification data from the GUDID. Will manufacturers be able to designate several people to enter data into the GUDID? If so, will each person be required to register and have their own login? What is the process for inputting the required information? Will the GUDID be used to track customer use? Will the GUDID have a report-generating feature that can be used by manufacturers? Please clarify the coded values for the fields that will be used to input labeling information under 830.310 for sterility, latex, size, premarket number, etc. to ensure that they can be used with clinical electronic health record (EHR) systems. From the post market perspective, to what extent can the GUDID benefit overseas regulators if confidential information (e.g., contract manufacturers information) contained within GUDID remains encrypted to the overseas regulators? Due to confidentiality clauses, overseas regulators cannot access confidential information in GUDID. Without the benefit of decrypted information, the string of numbers and characters in UDI has no meaning to an overseas regulator. Currently, the Global Medical Device Nomenclature (GMDN) system of medical device codes contains a very high number of detailed codes for essentially the same product. For example, the Universal Medical Device Nomenclature System (UMDNS) includes 4 codes for magnetic resonance (MR) units, while the GMDN employs 32 terms for an MRI system. The mapping and grouping of various device categories for vigilance purposes would be hampered by the granularity utilized in the GMDN system. Moreover, it seems different manufacturers have chosen, in the GMDN system, different terms for products that should be grouped in the same category, possibly for commercial reasons. This proliferation of codes and terms is not in keeping with the purpose of the UDI system as proposed by FDA, so MITA recommends including in the GUDID guidance some guidelines that would restrict the arbitrary creation of new codes in the proposed UDI system. Alternatively, MITA recommends that FDA create its own set of codes prior to implementation of the UDI system, or utilize a different nomenclature (e.g. UMDNS), rather than the GMDN system of codes. Format of Dates Provided on Medical Device Labels Proposed 801.18 would require all dates provided on medical device labels to conform to a specified format: Month, Day, Year, with the month shown as a three-letter abbreviation of the month (e.g. SEP 30, 2011). This is the format most commonly used in the United States. But internationally, a different format Day Month Year (30 SEP 2011) is more prevalent. 32. Will a specified format for dates on medical device labels reduce confusion concerning expiration dates? 33. Which format would patients better understand, the U.S. format (e.g., SEP 30, 2011), or the international format (e.g., 30 SEP 2011)? 7
34. Which format would health care professionals better understand, the U.S. format (e.g., SEP 30, 2011), or the international format (e.g., 30 SEP 2011)? 35. Is there a strong reason to favor one format over the other? MITA strongly urges FDA to adopt the ISO 8601 standard, which describes the international date format (yyyy-mm-dd). This format should be adopted, since it is globally recognized, and most medical devices sold in the United States have worldwide distribution. This is consistent with the principle that the UDI system should be based on existing, broadly-accepted standards. Furthermore, the use of a purely numerical date will reduce confusion related to literacy or language. Additional MITA Comments on the Proposed Rule In addition to its comments in response to FDA s specific questions, which are outlined above, MITA has the following additional comments on the proposed rule: MITA recommends that proposed 801.30(a)(3) should apply to both class I and class II devices. MITA would appreciate additional clarification on how FDA will use the exception provided in proposed 801.30(a)(10). It is unclear how performance standards are related to the UDI rule. Requests for exception from the requirement for a device to bear a UDI under proposed 801.35 should be permitted as part of a premarket submission because premarket submissions are reviewed by various branches, which may have differing standards for granting the exception. Requests for UDI rule exceptions should be submitted to the Division of Small Manufacturers, Consumer, and International Assistance (DSMICA). It is unclear how FDA intends to apply the requirements for direct marking in proposed 801.50(b) to stand-alone software devices. MITA would appreciate additional clarification on how this requirement should be met. It is unclear how FDA intends production identifiers as defined in proposed 801.3 to be used for stand-alone software products. MITA would appreciate additional guidance on which productions identifiers FDA believes apply to stand-alone software. Please clarify the impact on the labeler or manufacturer if the accredited agency relinquishes its accreditation. MITA recommends that accredited UDI systems be developed in such a way to facilitate the transfer of data from one agency to another with little difficulty in order to protect the interests of the device industry, as well as patients and physicians who depend on the availability of medical devices in the United States. FDA s explanatory comments on page 40758 of the Federal Register notice announcing the proposed rule indicate that the proposed amendments to 21 C.F.R. Part 806 permit and encourage the use of UDIs in reports of corrections and removals; however, the proposed regulations actually require the inclusion of the UDI in the company s records. FDA s comments should align with the proposed regulation. It is unclear where the application of UDIs to packaging levels stops. MITA would appreciate additional clarity on this issue. For example, would FDA expect a UDI on a shipping pallet if that pallet contained only one product? Conclusion 8
MITA appreciates FDA s effort to develop a UDI system for the United States. However, many of the provisions discussed above are unclear or would significantly increase financial and regulatory burdens on manufacturers without clear benefit. MITA stands ready to work with FDA to develop a UDI system that achieves the laudable goals set forth by the agency without unduly burdening industry and driving up the costs of medical devices in the United States. If you have any questions, please feel free to contact me at 703-841-3279 or by email at grodriguez@medicalimaging.org. Sincerely, Gail Rodriguez Executive Director, Medical Imaging & Technology Alliance (MITA) Vice President, National Electrical Manufacturers Associations (NEMA) 9