# Unique Device Identification System > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2012-16621 ## Record - **Collection:** Federal Register - **Document type:** Proposed Rule - **Published:** July 10, 2012 - **Citation:** 77 FR 40736 ## Text DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830 [Docket No. FDA-2011-N-0090] RIN 0910-AG31 Unique Device Identification System AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA) is proposing to establish a unique device identification system to implement the requirement added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by section 226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), Section 226 of FDAAA amended the FD&C Act to add new section 519(f), which directs FDA to promulgate regulations establishing a unique device identification system for medical devices. The system established by this rule would require the label of medical devices and device packages to include a unique device identifier (UDI), except where the rule provides for alternative placement of the UDI or provides an exception for a particular device or type of device such as devices sold over-the-counter and low risk devices. Each UDI would have to be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI would also be required to be directly marked on the device itself for certain categories of devices for which the labeling requirement may not be sufficient, for example, those that remain in use for an extended period of time and devices that are likely to become separated from their labeling. The rule would require the submission of information concerning each device to a database that FDA intends to make public, to ensure that the UDI can be used to adequately identify the device through its distribution and use. DATES: Submit either electronic or written comments on the proposed rule by November 7, 2012. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by September 10, 2012, (see section V, the “Information Collection Requirements” section of this document). See section VII for the proposed effective date of a final rule based on this proposed rule. ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-N-0090 and/or RIN No. 0910-AG31, by any of the following methods, except that comments on information collection issues under the Paperwork Reduction Act of 1995 (see the “Information Collection Requirements” section of this document) must be submitted to the Office of Regulatory Affairs, Office of Management and Budget (OMB) at FAX: 202-395-7285, or email comments to OIRA_submission@omb.eop.gov. Please mark your comments to the attention of the FDA desk officer and reference this rule. Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Written Submissions Submit written submissions in the following ways: • Fax: 301-827-6870. • Mail/Hand delivery/Courier [For paper or CD-ROM submissions]: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Instructions: All submissions received must include the Agency name, Docket No., and Regulatory Information Number (RIN) for this rulemaking. All comments received may be posted without change to http://www.regulations.gov , including any personal information provided. For additional information on submitting comments, see the “Comments” heading of the SUPPLEMENTARY INFORMATION section of this document Docket: For access to the docket to read background documents or comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Jay Crowley, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, 301-796-5995, email: cdrhudi@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Executive Summary Purpose of the Regulatory Action This rule is intended to substantially reduce existing obstacles to the adequate identification of medical devices used in the United States. By making it possible to rapidly and definitively identify a device and key attributes that affect its safe and effective use, the rule would reduce medical errors that result from misidentification of a device or confusion concerning its appropriate use. The identification system established under this rule would lead to more accurate reporting of adverse events by making it easier to identify the device prior to submitting a report. It would allow FDA, healthcare providers, and industry to more rapidly extract useful information from adverse event reports, pinpoint the particular device at issue and thereby gain a better understanding of the underlying problems, and take appropriate, better-focused, corrective action. The rule will also require dates on medical device labels to conform to a standard format to ensure those dates are unambiguous and clearly understood by device users. The rule will fulfill the statutory requirement of section 519(f) of the FD&C Act (21 U.S.C. 360i(f)), which directs FDA to promulgate regulations establishing a unique device identification system for medical devices; this requirement was added to the FD&C Act by section 226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), Public Law 110-85. In developing the proposed rule, FDA has been partnering with industry to conduct pilot tests to identify potential issues and generate feedback on the development of a UDI system. Throughout the pilot activities, labeler organizations from the medical device industry focused on identifying and understanding potential issues that would arise for labelers in implementing UDI and provided that feedback to FDA. The proposed rule reflects this industry input and the lessons learned from these pilot activities. FDA also solicited input through public meetings; a public workshop with stakeholders from the medical device industry, hospitals, payors and other stakeholders; and, a public request for information on a series of key questions related to the development of UDIs through which FDA received extensive input from the medical device industry and the broader healthcare community. FDA solicits comments on the proposed rule from all interested stakeholders, and is particularly interested in industry comment on whether the proposed approach reflects the lessons from the pilot activities. Under the proposed system, the health care community and the public would be able to identify a device through a UDI that will appear on the label and package of a device. The UDI will provide a key to obtain critical information from a new database, the Global Unique Device Identification Database (GUDID), which will include information important to the identification of devices. UDIs will appear in both plain-text format and a format that can be read by a bar code scanner or some other AIDC technology. Certain devices for which the labeling requirement alone may not be sufficient would also be directly marked with a UDI, allowing accurate identification even when the device is no longer accompanied by its label or package. The types of devices that would be subject to the direct marking require are implantable devices; devices intended to be used more than once, and which are intended to be sterilized before each use; and stand-alone software. These types of devices have physical characteristics, or characteristics of use, that significantly increases the probability that the device will become separated from its label, particularly when used over an extended period of time. By ensuring the adequate identification of medical devices through distribution and use, the rule would serve several important public health objectives— Reduce Medical Errors. The presence of a UDI that is linked to device information in the GUDID database will facilitate rapid and accurate identification of a device, thereby removing a cause of confusion that can lead to inappropriate use of a device (e.g., confusion as to whether a device is packaged as sterile, or failure to recognize that a device is the subject of a recall or enforcement action). Using a device's UDI, you will be able to use the GUDID to positively identify the device and obtain important descriptive information, preventing confusion with any similar device which might lead to misuse of the device. Health care providers will no longer have to access multiple, inconsistent, and potentially incomplete sources in an attempt to identify a device, its key attributes, and a designated source for additional information. Simplify the Integration of Device Use Information Into Data Systems. UDIs, particularly when provided through AIDC technology, would allow rapid and accurate data acquisition, recording, and retrieval. The use of UDIs in computerized physician order entry systems will help ensure that the intended device will be used in the treatment of a patient, rather than some similar device that may not fully meet the requirements of the health care professional who ordered the use of the device. Provide for More Rapid Identification of Medical Devices With Adverse Events. An essential prerequisite to resolving adverse events is the timely and precise identification of the particular device or devices that may have a connection with an adverse event. The inclusion of UDIs in adverse event reports would lead to greater accuracy in reporting, by eliminating uncertainty concerning the identity of the device that is the subject of a report. Provide for More Rapid Development of Solutions to Reported Problems. The rule also would require the inclusion of UDIs in adverse event reports that are required under part 803. This would allow manufacturers and FDA to more rapidly review, aggregate, and analyze related reports regarding a particular device, leading to more rapid isolation and identification of the underlying problems, and development of an appropriate solution to a particular concern. Provide for More Rapid, More Efficient Resolution of Device Recalls. Delays in identifying recalled devices can result in the continued use of those devices on patients and involves an increased risk for patient harm. A device labeled with a UDI can be identified rapidly and with great precision and the UDI, particularly when combined with AIDC technology, will hasten the identification of devices that are the subject of a recall. The more rapidly a recall is implemented and completed, the more rapidly the risks presented are reduced and eliminated. Better-Focused and More Effective FDA Safety Communication. By citing UDIs, FDA would be able to more precisely focus safety alerts, public health notifications, or other communications, eliminating confusion with similar devices and allowing more rapid responsive action. Users of similar devices that are not the subject of the safety alert would be relieved of the uncertainty concerning whether they have been exposed to, or are affected by, a problem or risk. Provide an Easily-Accessible Source of Definitive Device Identification Information. While not required, inclusion of device identifiers in informational and educational materials, such as package inserts, training materials, educational materials, and other supplementary information, could provide a quick and useful means for patients and health care professionals to obtain additional information concerning a device, without having to provide that information in the document. This could allow the document to focus on its important core messages without the distraction of greater complexity, while a reader who wants those additional details could use the UDI to obtain information from the GUDID. Additional Benefits. FDA expects the UDI system will provide additional benefits. For example, UDIs could be used to enhance management of the Strategic National Stockpile, inventory management, and the provision of high-quality medical services. UDIs will facilitate the development of more useful electronic patient records by allowing providers to electronically capture and record important information concerning the use (including implantation) of a device on a patient. UDIs could help identify similar devices in the event of a shortage, and could help detect counterfeit devices. Standard Format for Dates Provided on a Device Label or Package. The rule would also contribute to improved identification of medical devices, and at the same time, better ensure the safe use of devices, by requiring dates on medical device labels to conform to a standard format—Month, Day, Year (e.g. JAN 1, 2012)—to ensure dates are unambiguous and clearly understood by device users. Summary of the Major Provisions of the Regulatory Action in Question This rule would require the label of medical devices and device packages to include a UDI, except where the rule provides for alternative placement of the UDI or provides an exception for a particular device or type of device. Each UDI would have to be provided in a plain-text version and in a form that uses AIDC technology. The UDI would also be required to be directly marked on the device itself for certain categories of devices, such as those that remain in use for extended periods of time and are likely to become separated from their labeling. The rule would require the submission of information concerning each device to a database that FDA intends to make public, to ensure that the UDI can be used to adequately identify the device through its distribution and use. The FDA database would not include patient information. The rule would also require dates on device labels and packages to be presented in a standard format. The UDI system proposed by this rule builds on international regulatory cooperation activities and existing, internationally recognized standards relating to unique identification and data exchange. The rule would specify the technical requirements of a UDI, which would consist of a portion that identifies the specific version or model of the device and the labeler of the device (the device identifier), and a portion that more precisely identifies the specific device by providing variable information, such as the lot or batch, the serial number, expiration date, or date of manufacture (the production identifier). Devices exempted from this proposed rule include devices, other than prescription devices, that are sold at retail establishments; this exception also applies to such a device when delivered directly to hospitals and other health care facilities. Also exempted are class I devices that FDA has by regulation exempted from the good manufacturing practice requirements of part 820 of this chapter. The production identifier would not be required for Class I devices. The proposed rule explains when a UDI is required and when its use must be discontinued. The rule would require all UDIs to be issued under a system operated by an FDA-accredited issuing agency. The rule would provide a process through which an applicant would seek FDA accreditation. The proposed rule specifies the information that the applicant would provide to FDA and the criteria FDA would apply in evaluating applications. The rule includes provision for the suspension or revocation of the accreditation of an issuing agency, and explains the circumstances under which FDA will, or may, act as an issuing agency. Whenever a device must bear a UDI, the labeler of that device would be required to submit information concerning the device to FDA to facilitate the rapid identification of the device and the labeler, and to provide links to other FDA data. FDA will make this information available to the public through a variety of channels, including a new database, the GUDID. The rule provides for appropriate exceptions and alternatives, ensuring that the costs and burdens are kept to a minimum. A final rule would become effective in stages, over a period of seven years, to ensure a smooth implementation and to spread the costs and burdens of implementation over time, rather than having to be absorbed all at once. BILLING CODE 4160-01-P EP10JY12.008 BILLING CODE 4160-01-C Table of Contents I. Background A. Objectives of the Proposed Rule 1. Reduce Medical Errors 2. Simplify the Integration of Device Use Information Into Data Systems 3. Provide for More Rapid Identification of Medical Devices With Adverse Events 4. Provide for More Rapid Development of Solutions to Reported Problems 5. Provide for More Rapid, More Efficient Resolution of Device Recalls 6. Better Focused and More Effective FDA Safety Communication 7. Provide an Easily-Accessible Source of Definitive Device Identification Information 8. Additional Benefits B. Certain Public Health Benefits of UDI Depend on the Adoption of IT Systems by Hospitals and Other Healthcare Facilities and on Statistical Methodologies to Interpret the Data Aggregated Using the UDI C. Principles That Guided Development of the Proposed Rule D. Prior Consultation With the Health Care Community and Industry II. Description of the Proposed Rule A. Overview B. UDI Labeling Requirements (Part 801) 1. Definitions 2. When would the requirement for UDI labeling go into effect, and where would the UDI have to appear? 3. How would UDI labeling requirements apply to a combination product and a device constituent part of a combination product? 4. How would UDI labeling requirements apply to a convenience kit? 5. Exceptions From, and Alternatives to, UDI Labeling Requirements 6. May a device that is exempt from UDI labeling requirements nevertheless be labeled with a UDI? 7. How would a UDI have to appear on a device label and on a device package? 8. When would a device have to be directly marked with a UDI? 9. After the requirement for UDI labeling goes into effect, may I continue to identify my device with the national health-related item code (NHRIC) or national drug code (NDC) number assigned to it? 10. Formatting of Dates Provided on Medical Device Labels C. Requirements Relating to Issuing Agencies and Submission of Data to the Global Unique Device Identification Database (Part 830) 1. Definitions 2. What would be the requirements for the composition and issuance of a valid unique device identifier? 3. Use and Discontinuation of a Device Identifier 4. What changes would require a new device identifier? 5. How would FDA accredit an issuing agency? 6. What would be the responsibilities of an FDA-accredited issuing agency? 7. How would an issuing agency relinquish its accreditation, and how would FDA suspend or revoke an issuing agency's accreditation? 8. When would FDA act as an issuing agency? 9. What devices would be subject to GUDID data submission requirements? 10. Would FDA ever reject data submitted to the GUDID or remove data from the GUDID? 11. What device identification data would I have to submit to the GUDID? 12. How would I have to submit device identification data to the GUDID? 13. When would I have to submit device identification data to the GUDID? 14. Would I be permitted to submit information to the GUDID that is not required by FDA? 15. What records would a labeler be required to maintain concerning its UDIs? 16. Who would have access to the information I submit to the GUDID? D. Conforming Amendments III. Legal Authority for the Proposed Rule IV. Analysis of Impacts A. Summary of Costs 1. Costs to Domestic Labelers 2. Costs to Issuing Agencies 3. Costs to FDA to Establish and Maintain the GUDID 4. Cost to Foreign Labelers 5. Uncertainty 6. Alternatives B. Summary of Regulatory Flexibility Analysis C. Summary of Benefits V. Information Collection Requirements A. Reporting Requirements B. Recordkeeping Requirements C. Total Annual Cost Burden VI. Environmental Impact VII. Proposed Effective Date VIII. Federalism IX. Request for Comments A. Submission of Comments B. Specific Questions X. References I. Background A. Objectives of the Proposed Rule This rule is intended to substantially reduce existing obstacles to the adequate identification of medical devices used in the United States. By providing the means to rapidly and definitively identify a device and key attributes that affect its safe and effective use, the rule would reduce medical errors that result from misidentification of a device or confusion concerning its appropriate use. The identification system established under this rule would lead to more accurate reporting of adverse events by making it easier to identify the particular device involved prior to submitting a report. It would also allow FDA, healthcare providers, and industry to more rapidly extract useful information from adverse event reports, pinpoint the particular device at issue and thereby gain a better understanding of the underlying problems, and take appropriate, narrowly-focused, corrective action. The rule will fulfill a statutory directive to establish a unique device identification system. Section 226 of FDAAA amended the FD&C Act to add new section 519(f), which directs FDA to promulgate regulations establishing a unique device identification system for medical devices: “ Unique Device Identification System. The Secretary shall promulgate regulations establishing a unique device identification system for medical devices requiring the label of devices to bear a unique identifier, unless the Secretary requires an alternative placement or provides an exception for a particular device or type of device. The unique identifier shall adequately identify the device through distribution and use, and may include information on the lot or serial number.” Under the system that would be established by this proposed rule, two tools would be used together to identify a device: A UDI on the label and packaging of a device (represented both in plain text and through automatic identification and capture technology), and a new database, the GUDID, containing device identification information for each UDI. Certain devices, such as those that remain in use for extended periods of time and are likely to become separated from their labeling, would also be directly marked with a UDI, allowing accurate identification even when the device is no longer accompanied by its label or package. The principles behind the rule's requirements and exceptions regarding UDI labeling and the GUDID are discussed in more detail in section I.B of this document. By requiring adequate identification of medical devices through distribution and use, the rule would serve several important public health objectives— 1. Reduce Medical Errors Device-related medical errors are a serious problem. The presence of a UDI that is linked to identifying information in the GUDID database will facilitate rapid and accurate identification of a device, thereby removing a cause of confusion that can lead to inappropriate use of a device (e.g., confusing a sterile version or model with a version or model that is not sterile and which requires sterilization prior to use, or failing to recognize that a particular device is the subject of a recall or enforcement action). The presence of AIDC technology as part of a UDI would make it possible to “scan” a device at a patient's bedside and rapidly compare the device attributes reported to the GUDID with the medical order and the patient's history, thereby improving the accuracy of device use and providing greater assurance that a device is appropriate for the patient. Providing a single, authoritative source of information—the GUDID—to facilitate the unambiguous identification of medical devices used in the United States. The proposed system would allow anyone to use a device's UDI to look up identifying information in the GUDID concerning the device, including: The FDA premarket submission number of the device; the proprietary, trade, or brand name of the device; any version or model number or similar reference; the Global Medical Device Nomenclature (GMDN) generic descriptor for the device; if the device is available in more than one size, the size of the particular version or model, together with the unit of measure; the total number of devices in the package; and an email address or telephone number for a contact who can provide additional information to FDA. Together, this information will permit positive identification of the device and prevent confusion with any similar device. Health care providers will no longer have to access multiple, inconsistent, and potentially incomplete sources in an attempt to identify a device, its key attributes, and a designated source for additional information. Ensuring the accurate identification of certain devices, even when the device is separated from its label and package. The rule would require some devices to be directly marked with a UDI, so that it will always be possible to positively identify the device, regardless of how long the device remains in use. These devices, by their intended or customary use, are typically separated from the labeling that accompanies delivery of the device to users: • An implantable device; • A device that is intended for more than one use and to be sterilized before each use; and • Stand-alone software. These devices involve unique risks to patients, and consequently it is particularly important to ensure the adequate identification of such devices throughout the entire product life cycle. For example, a device that is intended for more than one use, but which must be sterilized before each use, might be used over several years; during that time, the device package, with its label and any package insert, might be lost, leaving the user of the device uncertain as to whether the device needs to be sterilized, or just given a routine cleaning, and if sterilization is required, what type of sterilization process should be employed. The same is true for implanted devices and stand-alone software—loss of the device package and accompanying labeling can leave the user uncertain as to how to use the device, how to monitor its performance, or what actions should be taken in particular circumstances. Providing rapid and continuous access to key information relating to the device. FDA intends to provide Internet access to all data in the GUDID. Furthermore, once data concerning a device has been submitted to the GUDID, it will remain available long after production and marketing of the device has ceased. The GUDID will include information important to the identification of the device, but will not include patient information. 2. Simplify the Integration of Device Use Information Into Data Systems UDIs, particularly when provided through AIDC technology, would allow rapid and accurate data acquisition, recording, and retrieval. The use of UDIs in patient records, particularly electronic patient records, would help avoid confusion among similar devices during an extended treatment period and where more than one health care provider is involved in the administration of a course of treatment. The use of UDIs in computerized physician order entry systems will help ensure that the intended device will be used in the treatment of a patient, rather than some similar device that may not fully meet the requirements of the health care professional who ordered the use of the device. 3. Provide for More Rapid Identification of Medical Devices With Adverse Events An essential prerequisite to resolving adverse events is the timely and precise identification of the particular device or devices that may have a connection with an adverse event. The proposed UDI system would make this possible. From 2005 through 2009, FDA received an average of more than 492,000 adverse event reports involving devices each year. During this 5-year period, more than 17,700 reports involved a death, and more than 283,000 reports involved an injury. Because reports come from multiple sources—manufacturers, device user facilities, importers, and voluntary reports from physicians and other concerned individuals—we often receive more than one report of a particular death or injury. Reviewing a significant number of reports, seeking essential missing information, and resolving inconsistencies among reports are major challenges, particularly when trying to identify recurring problems involving a particular device. Although we do not have precise statistics, many initial reports do not provide a precise identification of the specific device the report concerns and require extensive FDA follow-up to identify the specific device involved. The inclusion of UDIs in adverse event reports would lead to greater accuracy in reporting, and eliminate uncertainty concerning the identity of devices that are the subject of reports. 4. Provide for More Rapid Development of Solutions to Reported Problems The inclusion of UDIs in adverse event reports would allow manufacturers and FDA to more rapidly review and analyze reports and identify the particular device at issue. This would permit more rapid isolation and identification of the underlying problems, and development of an appropriate solution to a particular concern. UDIs would also allow FDA, manufacturers, and the healthcare community to more accurately target safety alerts, recalls, and other corrective actions on the specific devices that are of concern. UDIs, particularly when provided using AIDC technology, would allow device user facilities and health care professionals to identify those devices more rapidly and with greater assurance, and prevent further patient exposure. At the same time, devices not implicated by the problem would be less likely to be “swept up” in an over-broad attempt to remove potentially hazardous devices. 5. Provide for More Rapid, More Efficient Resolution of Device Recalls Currently, locating all devices subject to a recall is a time- and labor-intensive process. Manufacturers, distributors, and healthcare facilities often do not know how many recalled devices they have in stock, do not know exactly where those devices are located, and are sometimes uncertain which of several similar devices is the subject of a recall. Consequently, delays in identifying recalled devices can result in the continued use of those devices on patients in a variety of settings (e.g., hospitals, long-term care facilities, homecare environments) and involves an increased risk for patient harm. A device labeled with a UDI can be identified more rapidly and with greater precision than a device that does not bear a UDI. The use of AIDC technology, such as a bar code, would allow increased use of automation to speed efforts to identify specific devices that are the subject of a recall. The more rapidly a recall is implemented and completed, the more rapidly the risks presented are reduced and eliminated. A class 1 recall is the most serious type of recall, and involves a situation where there is a reasonable probability that use of the device will cause serious injury or death. It is particularly important, therefore, that a class 1 recall be completed as rapidly as possible. The absence of a system that allows rapid and reliable identification of the particular devices that are being recalled means hospitals and health care professionals have to rely on a variety of identification systems and examine a variety of attributes to identify a recalled device. A class 1 recall may direct that a device be returned to the manufacturer for exchange or refund, be destroyed, or be subjected to some other corrective action, such as a software upgrade. Any confusion or lack of complete clarity in identifying the device will undermine the effectiveness of the recall. Therefore, each recall attempts to identify the device as precisely as possible, but the great variation in devices and the terms used to describe them can make it difficult to describe a device with complete clarity. Here are some of the descriptors manufacturers used to identify specific devices subject to class 1 recalls during 2008 and 2009: Table 2—Examples of Descriptors Used To Identify Devices Subject to Class 1 Recalls During 2008 and 2009 Descriptor Example of a recall that used the descriptor Catalog number Pointe Scientific, Inc., Liquid Glucose Hexokinase Reagent (October 19, 2009). Lot number Covidien Pedi-Cap End-Tidal CO2 Detector (July 17, 2009). Material Number Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System (June 6, 2008). Model number Baxter Colleague Single and Triple Channel Volumetric Infusion Pumps (January 23, 2009). Part number Synthes USA, Ti Synex II Vertebral Body Replacement (September 14, 2009). “Product code” Smiths Medical ASD, Inc., Portex Uncuffed Pediatric-Sized Tracheal Tubes (August 25, 2009). Note: The “product code” used here is a code developed by Smiths Medical; it is not the product code used by FDA. Product number Physio Control, Inc. LifePak CR Plus Automated External Defibrillators (August 29, 2008). Serial number ZOLL Medical Corporation, ZOLL AED Plus Defibrillator (February 12, 2009). Universal Product Code (UPC) Luv N' Care Gel-Filled Teethers—“Nuby,” “Cottontails,” and “Playschool” (July 17, 2009). Often, a recall must cite more than one descriptor to identify the specific devices subject to the recall. For example, a September 22, 2009, class 1 recall of the Penumbra, Inc., Neuron 6F 070 Delivery Catheter required reference to both the product catalog number and the lot number to determine whether a particular catheter was subject to the recall, and a June 17, 2009, class 1 recall of Abbott Vascular-Cardiac Therapies/Guidant Corp. POWERSAIL Coronary Dilatation Catheters referred to product designation, product number, lot number, and expiration date. Recalls would be expedited and simplified if a single descriptor, such as the proposed UDI, could serve to adequately identify all devices. There is no uniformity in the placement or formatting of the descriptors presently used to identify devices, and no assurance that different companies are using a given term in the same way. The inconsistency in methods used to identify a recalled device complicates efforts to identify such devices that remain in possession of a patient, physician, or in a hospital's inventory and to complete the remedial action that would mitigate or eliminate the risk of further harm. These problems would be significantly reduced by the presence of UDIs on the labels and packaging of devices and the inclusion of UDIs in recall notification information. The inclusion of AIDC technology, such as a bar code or a RFID tag, would permit inventories to be checked more rapidly and would result in the more accurate detection and removal of recalled devices. 6. Better-Focused and More Effective FDA Safety Communication By citing a device identifier, or a range of UDIs, FDA would be able to more precisely focus a safety alert, public health notification, or other communication on the particular device that is the subject of the alert, eliminating confusion with similar devices. Health care professionals and patients would be able to take responsive action more rapidly, and users of similar devices that are not the subject of the safety alert would not be faced with the uncertainty of not knowing whether they have been exposed to, or are affected by, a problem or risk. 7. Provide an Easily-Accessible Source of Definitive Device Identification Information While not required, inclusion of device identifiers in informational materials, such as package inserts, could provide a quick and useful means for patients and health care professionals to obtain additional information concerning a device, without having to provide that information in the document. This could allow the document to focus on its important core messages without the distraction of greater complexity, while a reader who wants those additional details could use the UDI to obtain information from the GUDID. 8. Additional Benefits FDA has concluded that a UDI system has the potential to provide additional benefits. For example, we expect UDIs could be used by other Federal agencies, such as the Centers for Medicare and Medicaid Services, the National Institutes of Health, the Centers for Disease Control and Prevention, the Department of Defense, the Department of Homeland Security, and the Department of Veterans Affairs, for a wide variety of purposes, ranging from management of the Strategic National Stockpile, inventory management, and the provision of high-quality medical services. Other benefits include facilitating the development of more useful electronic patient records by allowing providers to electronically capture and record important information concerning the use of a device on a patient. UDIs could help identify similar devices in the event of a shortage, and could reduce the potential for injury from counterfeit devices by offering a better way to detect a counterfeit product and remove it from the market. The UDI system would provide a basic infrastructural element, which would allow unambiguous identification of medical devices throughout their lifecycle and would provide the foundation for a host of benefits. These may include improved device traceability, improved postmarket surveillance, and better security of devices through more effective detection and removal of counterfeit devices, and other improvements that support FDA's public health mission. Through our work with the Global Harmonization Task Force (GHTF) and foreign regulatory partners, we envision that the UDI system would support global public health initiatives with which FDA is concerned, including more efficient and effective cross-border identification of devices, adverse event reporting and postmarket surveillance, and would improve our ability to communicate and respond to issues and concerns about devices used not only in the United States, but in other nations as well. B. Certain Public Health Benefits of UDI Depend on the Adoption of IT Systems by Hospitals and Other Healthcare Facilities and on Statistical Methodologies to Interpret the Data Aggregated Using the UDI The full benefits of UDI require that hospitals and other healthcare facilities concurrently adopt information technology (IT) to fully realize the enhanced ability to identify devices throughout distribution and use. In order to realize its full potential benefits, UDI users must be able to store UDI information in various administrative, clinical and payment information systems, including EHRs. Though many such systems exist today, changes will need to be made in the systems to accommodate UDI. The use of electronic health technology to reduce medical errors in healthcare facilities would require the use of scanners (many of which are already in place) and standard operating procedures for using newly developed systems that link critical patient information (such as latex sensitivity) with specific medical device information. Hospitals and other health-care facilities will choose to make investments in the new technology and methods if they expect it to be a cost-effective method to reduce errors and improve patient safety involving medical devices. Putting a standardized unique device identifier on a device label is one step in creating systems that could reduce device related medical errors. The proposed rule would create a platform that would enhance the value of the new electronic health technologies and thereby encourage their development. But the proposed rule does not require hospitals and other health care facilities to make these changes. C. Principles That Guided Development of the Proposed Rule In developing our proposed system for identification of devices, FDA first developed several general objectives, or principles, that we then applied throughout the drafting of our proposed rule. Each of these principles is identified in this section I.B, with a brief discussion of how they are resolved in the proposed rule. The UDI system should generally include all classes of devices, with appropriate exceptions. The healthcare community needs to identify a wide range of medical devices in every medical specialty. When fully phased-in, the rule will apply to all three device classes; however, we are proposing to exempt class I devices from production identifiers and proposing full exceptions from UDI labeling and data reporting for certain very low risk devices and other categories of devices; see proposed §§ 801.30, 801.35, and 801.128(f). Although we are not aware of compelling reasons for other exemptions based on the device class or medical specialty, for example, we seek comments on this issue. The UDI system should be based on existing, broadly-accepted standards. Basing the UDI system on existing, accepted standards ensures that all UDIs will be unique, broadly compatible, and broadly accepted for use by the U.S. healthcare community and in international commerce. By incorporating these existing standards into our proposed system, we avoid the confusion, inconsistency, and inefficiency that would result if every labeler created their own device identifiers without regard for the needs of the healthcare community. Therefore, the UDI system we are proposing would incorporate by reference four international standards: International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 646:1991, Information technology—ISO 7-bit coded character set for information interchange; ISO/IEC 15459-4:2006(E), Information technology—Unique identifiers—Part 2: Registration procedures; ISO/IEC 15459-4:2008, Information technology—Unique identifiers—Part 4: Individual items; and ISO/IEC 15459-6:2007, Information technology—Part 6: Unique identifier for product groupings. See proposed § 830.10. In addition, all widely-used AIDC technologies—e.g., bar codes, RFID tags, and near-field communication are based on established, broadly-supported standards. (Ref. 1) A multiplicity of nonstandardized systems would impose excessive costs on device user facilities and others, would provide no assurance that identifiers would be unique, would run counter to efforts to achieve international harmonization with regard to the identification of devices, and would greatly complicate FDA efforts to identify and resolve adverse events and other problems involving devices. The UDI system should recognize that the private sector has already implemented device identification systems, and, where possible, the rule should not require significant alteration of those systems. FDA is aware of two existing device identification systems that are based on the ISO/IEC standards discussed in the preceding paragraph. The International not-for-profit association known as “GS1” operates a system that uses a Global Trade Identification Number (GTIN) to identify a device; GS1 also operates the Universal Product Code (UPC) system that is used to identify most items sold by retail establishments in the United States. (Ref. 2) The Health Industry Business Communications Council (HIBCC) operates a system that encodes an identifier in a Health Industry Bar Code (HIBC) to identify a device. (Ref. 3) We believe roughly 35 to 50 percent of all medical devices used in the United States are already labeled with device identifiers that conform to one of the systems operated by these two organizations (a 2005 ECRI Institute report, “Automatic Identification of Medical Devices,” cited survey data suggesting bar codes were currently found on 25 percent of class I devices, 44 percent of class II devices, and 50 percent of class III devices) (Ref. 4). These existing systems are providing valuable services to device user facilities (hospitals, nursing homes, and other facilities) and to health care professionals. These systems have proven to be successful in creating unique identifiers that are in widespread use in systems used by hospitals, healthcare professionals, and industry. Because these existing systems include tightly-integrated functions that go far beyond simply identifying devices—functions such as inventory management and enabling commercial transactions that are not part of FDA's public health responsibilities and are outside our statutory authority—FDA believes it would be inefficient and counterproductive to try to replace the existing systems with a single, FDA-designed system of device identifiers. Because any FDA system would necessarily have a narrow scope limited to the adequate identification of devices, labelers would have to continue to use the existing systems as well as the FDA system, which would result in duplication of effort, substantial additional costs, and potentially confusing identification of devices that would undermine our public health objectives. Consequently, FDA's proposed UDI system will permit continued use of these existing systems, so long as the administering organizations apply for and obtain FDA accreditation, as discussed under question 5 of section II.C of this document. The GUDID will allow rapid access to key information concerning any device labeled with a UDI, regardless of the system used to assign the UDI. Burdens should be minimized. We have honed our proposed data submission requirements to minimize overlap and avoid inconsistency with other existing FDA regulatory requirements, such as establishment registration and device listing. We are proposing to require the submission of fewer types of data than those identified and discussed in the public meetings (Ref. 5) that influenced development of this proposed rule. See proposed § 830.310. We are requesting comments on whether we have adequately minimized overlap and inconsistency, and whether we should require or permit the submission of additional data that may be useful to the healthcare community. The UDI system should be open to technological advancements. The proposed rule would require each UDI to be provided in both a plain-text form and a form that uses AIDC technology. See proposed § 801.45. FDA would not require use of any particular technology for the AIDC form of the UDI. The system would permit the use of any type of bar code, RFID tag, near-field communication, or any other technology, whether existing at the present time or developed in the future. This would allow for technological evolution and advancement without prior FDA approval. FDA expects that a new technology would be deployed only after considerable consultation among issuing agencies, device user facilities, healthcare professionals, and device manufacturers, and we believe such decisions are best left in the hands of the healthcare community. The UDI system should be designed to integrate smoothly with other FDA systems, such as registration and listing, postmarket surveillance, and adverse event reporting. We have taken care to avoid conflict and minimize overlap with existing regulatory requirements, and we have included several conforming amendments to existing regulatory requirements to ensure UDIs are integrated in our regulatory processes wherever appropriate and feasible. For example, Part 810—Medical Device Recall Authority, Part 820—Quality System Regulation and Part 821—Medical Device Tracking Requirements. Requirements should be phased in over several years to ensure smooth and effective implementation. Pursuant to the proposed tiered effective dates, UDI requirements would be phased in over seven years following publication of a final rule (see table 7 of this document). This would allow all participants—FDA, industry, the health care community, and other government agencies—ample time to become familiar with and phase-in the rule's labeling and data submission requirements. This approach also provides FDA the opportunity to identify unforeseen weaknesses or problems in our implementation of the UDI system and to make appropriate mid-course corrections within the scope and authority of this rule, if finalized. We are proposing to phase in the rule's requirements by class because this will allow us to focus first on devices that have higher risks. The UDI system should foster innovation by, and competition among, issuing agencies. The proposed rule would allow for accreditation of multiple issuing agencies, see proposed § 830.100, so that the varying needs of labelers and users of different types of devices can be met by different systems with differing levels of complexity and function. Because all issuing agencies would have to employ systems based on the same technical standards, and would have to meet the same accreditation requirements, each system would still be broadly compatible with other systems. Furthermore, all systems would employ the FDA-administered GUDID database, which would serve as the single authoritative source of information for the positive identification of any device labeled with a UDI. We will maintain a list of all FDA-accredited issuing agencies on our Internet site. There will be effective FDA oversight of issuing agencies. Oversight is necessary to ensure that all device identifiers are unique and meet the proposed requirements, and that all system users are treated fairly. FDA is proposing to require that any organization that wishes to issue UDIs be accredited by FDA. See proposed § 830.20(a). We have included accreditation criteria and information submission requirements designed to ensure that only a well-qualified organization that would issue identifiers that comply with the proposed rule would be permitted to serve as an issuing agency. See proposed §§ 830.100 and 830.110. The UDI system should provide for appropriate regulatory flexibility, including exceptions and alternatives. Where possible, we have included reasonable flexibility in our proposal. For example, certain categories of devices would be excepted from UDI requirements, see proposed § 801.30, and labelers may request an exception or propose an alternative that would, for example, provide for more effective identification of a device, see proposed § 801.35. Direct marking requirements would apply only to certain narrow categories of devices and there would be some flexibility in how this requirement may be satisfied, see proposed § 801.50. We seek comment on whether these flexibilities achieve the appropriate balance. Safeguards should be provided to protect small businesses. We seek to do this in two ways. First, a business can choose to use any system provided by any accredited issuing agency, which will give the labeler a choice among a range of services at a range of fees. We anticipate that the participation of multiple issuing agencies will also lead to competition that will help ensure fees are reasonable. Second, FDA may act as an issuing agency if we find that a significant number of small businesses will be substantially harmed by the fees assessed by all accredited issuing agencies, see proposed § 830.200. If FDA acts as an issuing agency, any business would be permitted to use the FDA system and, under current law, there would be no fee, see proposed § 830.210. We expect this provision will encourage issuing agencies to be sensitive and responsive to the needs of small businesses. The establishment of a publicly accessible GUDID database is a critical component of an effective UDI system. It is important to understand that a UDI is simply a numerical or alphanumerical code and on its face is not itself intended to communicate any information directly concerning a device; you would not, for example, be able to parse out a segment that indicates that the device is a cardiovascular device, or that the device is packaged sterile, or that the device is marketed under a particular FDA premarket submission. Instead, the UDI would function as a reference number allowing you to find data concerning the device in an FDA database, the GUDID. The real value of a UDI is derived from its connection to corresponding information identifying the version or model of the device that bears the UDI, and an effective system of device identification requires both a UDI and a database to provide information concerning the particular version or model identified by that UDI. Our proposal would require the submission of information essential to the identification of a device, which would be provided freely and publicly through a single authoritative source, the GUDID. In order to serve the public health purposes discussed in section I.A of this document, the UDI system requires a GUDID that is freely and easily accessible to all—hospitals and other device user facilities, health care practitioners, patients, other government agencies, academia, industry, and the general public. None of the information that we are proposing to collect would constitute trade secret information, confidential commercial information, or personal privacy information, and public disclosure of this information would not be prohibited. Open access to the GUDID would also encourage the integration of UDI data into healthcare delivery support systems, electronic medical records, and procurement, inventory management, and accounting systems, and would allow those systems to work together more effectively and efficiently. D. Prior Consultation With the Health Care Community and Industry In the Federal Register of February 26, 2004 (69 FR 9120), we published a final rule requiring bar codes on certain human drug and biological products to help reduce medication errors in hospitals and other health care settings. The bar code is intended to enable health care professionals to use bar code scanning equipment in conjunction with computerized medication administration systems to verify that the right drug, in the right dose, is being given to the right patient at the right time. This rule, now codified at 21 CFR 201.25 and 610.67, requires that manufacturers encode the unique National Drug Code (NDC) number in a linear bar code on the product's label. The bar code rule, however, does not apply to medical devices. In the preamble to the bar code rule, we stated that, unlike drugs, medical devices do not have a standardized, unique identifying system comparable to the NDC number, and that the absence of such a system complicates efforts to put bar codes on medical devices for purposes of preventing medical errors (69 FR 9120 at 9132). Since the issuance of the final bar code rule, various entities have asked that we revisit the issue of bar coding for medical devices to improve patient safety, quality of care, and cost effectiveness of health care, e.g., by improving delivery and supply chain efficiency. In response to this, in 2005 FDA met with various stakeholders, including device manufacturers and distributors, hospital associations, and other Federal agencies to solicit information and comments about employing a uniform system for the unique identification of medical devices. As a result of these meetings, FDA believes the majority of stakeholders support the development of a uniform system of unique identifiers as a way to improve patient safety and recognize other ancillary benefits such as better management of the purchase, distribution, and use of medical devices. However, there were a variety of experiences and opinions about how best to implement such a system. In 2006, we commissioned a report from Eastern Research Group, Inc. (ERG), concerning the benefits, costs, and issues with developing and implementing a UDI System. (Ref. 6) Thereafter, we published a notice in the Federal Register of August 11, 2006 (71 FR 46233), requesting comments to help us understand how a unique device identification system could improve patient safety, for example, by reducing medical errors, facilitating device recalls, and improving medical device adverse event reporting. We used the comments responding to the August 2006 Federal Register notice to help develop the agenda and topics for a public meeting held on October 25, 2006. (Ref. 5) The information we received helped us move forward with development of a proposed rule, which was further spurred by enactment of FDAAA. FDA held a public workshop on February 12, 2009, to discuss issues relating to establishment of a UDI system (see 74 FR 2601, January 15, 2009). (Ref. 5) We asked device identification standards organizations to discuss the development and use of UDI standards, including the use of production identifiers. We asked device manufacturers to discuss the use of standards and the marking of devices with UDIs. We also discussed the potential development and use of a UDI database in general and with respect to particular attributes, as well as issues relating to implementation of a UDI system by interested stakeholders (e.g., distributors, hospitals, payors). We asked device manufacturers to describe their current practices for applying standards to medical devices, including identifiers on medical device labels, and managing medical device identifier data. We also requested information regarding the difficulties and costs involved in adding a UDI to a device's label, including effects on manufacturing and labeling processes and expected capital and operating costs. We asked device user facilities (hospitals, nursing homes, and clinics) to describe how a UDI system could be used, the costs involved, whether a UDI system would require any change in operations, and how UDIs would affect adverse event reporting and recall management. We asked all interested persons to submit comments, including answers to any of these questions, to a regulatory docket, FDA-2008-N-0661, CDRH 200866—Unique Device Identification System; Public Workshop. Comments received by the docket may be reviewed at http://www.regulations.gov by searching for “FDA-2008-N-0661” (enter this text in the search field following “Enter Keyword or ID”). We carefully reviewed and considered all comments during our development of this proposed rule. II. Description of the Proposed Rule A. Overview The core requirements summarized here provide context for the more detailed discussions that follow: • Proposed § 801.18 provides for standardized formatting of dates on medical device labels, eliminating any possibility of confusion from date formats that might be interpreted in more than one way. • The labeler of each device would be responsible for meeting labeling and data submission requirements under this proposal. The labeler would, in most instances, be the manufacturer of the device. The term “labeler” is defined at proposed § 801.3, and is discussed in section II.B.1 of this document. • Unless the device is excepted, the label of a medical device, and a device package, marketed in the United States would be required to bear a UDI; this requirement would be phased in over 5 years. See proposed § 801.20. • The UDI would have to be provided in two forms: easily-readable plain-text and AIDC technology. See proposed § 801.45. These two forms ensure that the UDI of a device would be readily discernable to patients and health care professionals and to automated systems used to identify and manage devices. • The proposed rule provides several categorical exceptions, proposed § 801.30, as well as case-by-case exceptions and alternatives, proposed §§ 801.35 and 801.128(f)(2). • Direct marking would be required for certain categories of devices, with exceptions. For each device subject to direct marking, this requirement would go into effect two years after the base UDI labeling requirement goes into effect for that device. See proposed § 801.50. • Whenever a device must be labeled with a UDI, the labeler (the person who causes the label to be applied to the device) would have to submit data concerning that device to the GUDID database. See proposed § 830.320. This information would have to be submitted no later than the date the label of the device must bear a UDI, and would have to be updated when changes occur. See proposed § 830.330. Exceptions are identified in the detailed discussion of part 830. This data would be freely available to the public and would provide the information necessary to identify a device labeled with a UDI. • UDI labeling requirements would also apply to— ○ Certain combination products; ○ In most instances, to the device constituent parts of combination products; ○ Convenience kits; and ○ A device included in a convenience kit, except for a single use device. The terms “combination product” and “convenience kit” are defined at proposed § 801.3 and are discussed in section II.B.1 of this document. • UDIs would be issued under systems operated by FDA-accredited “issuing agencies” and conform to certain international standards, incorporated by reference at proposed § 830.10. A different UDI would be required for each version or model of a device. These terms are defined at proposed § 830.3. • In order to provide for efficient implementation of this rule, we propose to phase in its requirements over several years. Table 7 of this document, Effective Dates of UDI Regulatory Requirements, summarizes how we would phase in the requirements proposed in this rule. B. UDI Labeling Requirements (Part 801) Part 801 (21 CFR part 801) provides FDA's general medical device labeling requirements. All devices are subject to subparts A through E of part 801, while subpart H provides special requirements for specific devices; subparts B, F, and G are presently reserved. FDA provides additional labeling requirements in subpart B of part 809 that apply only to in vitro diagnostic products. FDA is proposing amendments to part 801 to provide UDI labeling requirements for devices. The changes we are proposing to part 801 provide a new definitions section, see proposed § 801.3; a new provision standardizing the format of dates provided on medical device labels, see proposed § 801.18; new subpart B, Labeling Requirements for Unique Device Identification; and a proposed amendment to § 801.128, regarding exceptions or alternatives to labeling requirements for medical devices held by the Strategic National Stockpile. Several definitions proposed for inclusion in part 801 would also be included in new part 830, Unique Device Identification. A proposed amendment to § 801.119 (the labeling regulation specifically applicable to in vitro diagnostic devices) would make it clear that all UDI labeling requirements apply to such devices. In order to avoid confusion with regard to the use of National Health Related Item Codes (NHRICs) and NDC numbers currently used to identify some devices, proposed § 801.57 would terminate the use of these legacy identifiers on the date the device must be labeled with a UDI; those dates are specified in proposed § 801.20(b). 1. Definitions The UDI regulation would not change the meaning of any term currently defined in Part 801. We are proposing, in new § 801.3, several definitions relating to the use of UDIs on device labels. New § 801.3 would not affect the existing definitions in part 801, and would not consolidate existing part 801 definitions into a single section. Each definition proposed in § 801.3 is discussed in this section II.B.1. Automatic identification and data capture (AIDC) technology would be any technology that conveys the UDI or the device identifier of a device in a form that can be entered into an electronic patient record or other computer systems via an automated process. AIDC technologies most often use bar codes, RFID, or near field communication, but this rule does not specify the technologies that may be used and does not prohibit the use of any particular technology. We believe it is best to leave decisions concerning the selection and use of any particular AIDC technology to issuing agencies, the labeler, and the health care community in order to avoid unintentional interference with the development and adoption of new and improved AIDC technology. Center Director —This would be the Director of the Center for Devices and Radiological Health, or the Director of the Center for Biologics Evaluation and Research, depending on which Center has lead responsibility for a particular device. Combination product —Within the context of the UDI system, a combination product will involve at least one device and at least one drug or one biological product. The term is defined by 21 CFR 3.2(e), and would have the same meaning here. A combination product whose primary mode of action is that of a device is subject to UDI labeling requirements; see proposed § 801.25(a). The constituent parts of a combination product would continue to be subject to all requirements that ordinarily apply to the particular type of product (device; drug; biologic), and this rule would require each device constituent part of a combination product to be labeled with its own UDI, regardless of whether the combination product is subject to UDI labeling. For example, the device constituent parts of a combination product whose primary mode of action is that of a drug would be subject to UDI labeling requirements; see proposed §§ 801.25(b). However, a device constituent part of a combination product would not be required to have a UDI if it is physically, chemically, or otherwise combined with other constituents of the combination product in such a way that it is not possible for the device constituent part to be used except as part of the use of the combination product; see proposed § 801.30(a)(11). A drug-eluting stent is an example of a combination product where the device constituent part—the bare-metal stent—has been combined with a drug constituent in such a way that it is not possible for the stent to the used except as part of the combination product. Convenience kit —When two or more different types of medical devices are packaged together for the convenience of the user, the result is a convenience kit. A convenience kit would have to have a UDI; see proposed § 801.25(c). Each device in a convenience kit would have to meet all FDA requirements that normally apply to a device of that type, including having its own UDI distinct from that of the convenience kit, except for single use devices included in a convenience kit; see proposed § 801.25(d). Device package —This definition is intended to clarify which articles would be required to bear a UDI under proposed § 801.20(a)(2). It is also intended to clarify the scope of the term version or model, which includes this term in its definition (consistent with current business practice, a change to the quantity of devices in a device package is one of the changes that results in a new version or model; see proposed § 830.50 and related discussion under the heading “ Version or model” of this section II.B.1). Since these requirements would be consistent with current practices—the existing GS1 and HIBCC systems, and the standards that underlie both of those systems and the proposed FDA UDI system—they will be well-understood, there will be no need for multiple identifiers on device packages, and we will avoid any need for duplicative and inconsistent identification. This term would be defined as a package that contains a fixed quantity of devices. A package may be a box or any other type of container in which devices are distributed or sold, and would include packages within other packages. Unlike a shipping container, whose contents and quantity may vary between shipments, the quantity of a device package would remain constant. If you change the quantity in a device package, you will have created a new device package. FDA is proposing this definition because the existing GS1 and HIBCC systems, and the international standards that underlie those systems, all require differentiation among packages that contain different quantities of a device in order to facilitate inventory management, order processing, and other business purposes. The proposed UDI system needs to recognize and accommodate these existing business systems and practices to avoid creating requirements that would lead the healthcare community and industry to have to devise a supplementary system to implement the UDI system, which would unnecessarily impose added costs and burdens and potentially undermine the effectiveness of the UDI system if multiple types of identifiers were used. We invite comment on this understanding of current systems and the extent to which the proposed definition accommodates current practice. A change to a device package that does not make substantive changes to the information conveyed thereon or to the quantity in the package would not result in a new device package; for example, a change in graphics, fonts, colors, or formatting would not result in a new device package, but a change in quantity would result in a new device package. Finished device —This term is defined because it is used in the definition of lot or batch, which is discussed below. In turn, the definition of lot or batch is based on a definition in FDA's Quality System Regulation. Expiration date —This term is not defined in any other medical device regulation, but is in common use and an expiration date (or “use by” date) is frequently provided on the labels of FDA-regulated products, including medical devices. The proposed definition is intended to capture the term's ordinary meaning, which we take to be the date by which the label of a device states the device must or should be used. We are defining the term because it is one of four production identifiers that, when provided on a device's label, would also have to be provided through a UDI (the other production identifiers are: The lot or batch of a device; the serial number of a device; and the date a device was manufactured); see the proposed definition of unique device identifier, which includes production identifier. FDA, we, or us would mean the Food and Drug Administration. Global Unique Device Identification Database (GUDID) would mean the FDA administered database that serves as a repository of information to facilitate the identification of medical devices through their distribution and use. This term would have the same definition in both parts 801 and 830; more information is provided later in this preamble, in the discussion of definitions used in part 830. Implantable device would mean a device that is intended to be placed in a surgically or naturally formed cavity of the human body. A device would be regarded as an implantable device only if it is intended to remain implanted continuously for a period of 30 days or more, unless the Commissioner determines otherwise in order to protect human health. Label would have the same meaning as is provided by section 201(k) of the FD&C Act. Labeler —This term would mean 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 subsequent replacement or modification of the label. In most instances, the labeler would be the device manufacturer, but the labeler may be a specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager, or a relabeler. The labeler would be responsible for meeting the UDI labeling requirements proposed for inclusion in part 801. The addition of the name of, and contact information for, a person who distributes the device, without making any other changes to the label, would not be a modification for the purposes of determining whether a person is the labeler. If a modification to the label extends beyond this narrow latitude, the person who causes the modification to be made will be a labeler and will be subject to the requirements of this rule. The term labeler does not include a person who labels a device, or who modifies the label of a device, pursuant to the instructions of the person who actually places the device into interstate commerce. Thus, a contractor who labels a device, following the instructions of the specification developer or manufacturer, would not be the labeler. Instead, the person who “causes” the label to be applied or modified—the person who provided the labeling instructions, whose name is on the device, and who actually places the device into interstate commerce (FDA refers to such a person as a specification developer)—would be the labeler and would be responsible for meeting UDI labeling requirements. Lot or batch —This definition is based on the definition used in the Quality System Regulation (QSR), § 820.3(m), but deletes the QSR language concerning components and the condition “whether or not it is packaged, labeled, or sterilized.” This is because UDI requirements would not apply until the device is labeled, and sterilization would not be a factor in determining whether a device would have to bear a UDI (the need for sterilization prior to each use would be relevant in determining whether a device must be directly marked under proposed § 801.50). Lot or batch is one of four production identifiers that, when provided on a device's label, must be provided through a UDI. See the proposed definition of unique device identifier. Shipping container —A shipping container would be a package, container, or pallet that is used for the shipment or transportation of devices from one point to another and whose contents may vary from one shipment to another. This rule would not require a UDI to be placed on any shipping container; see proposed § 801.30(b). Specification —This definition is intended to clarify the scope of “specification” as used in the definition of version or model. This definition builds on the definition of “specification” provided by the QSR, see § 820.3(y), but uses “device” instead of “product, process, service, or other activity,” because the QSR has a wider scope. Unique device identifier (UDI) —The definition cites proposed § 830.20, which specifies the requirements for a valid UDI, and the statutory mandate of the UDI system: To adequately identify a device through its distribution and use. A UDI may consist of two parts— • A device identifier that identifies the specific version or model of a device and the labeler of that device; and • A production identifier that identifies one or more of the following, when present on the label of the device: ○ The lot or batch within which a device was manufactured; ○ The serial number of a specific device; ○ The expiration date of a specific device; ○ The date a specific device was manufactured. The production identifier would not be required for class I devices; see § 801.30(c). The device identifier would always have to be present in a UDI. The production identifier must be present whenever a lot or batch number, serial number, date of manufacture, or expiration date appears on the label of the device, except for class I devices. Because most device labels provide at least one of these identifiers, most UDIs would have to include a production identifier. This proposed rule would not itself require any production identifier to appear on a device label, but other FDA regulations and conditions of approval may require one or more to be provided on the label of a particular device or type of device, and many labelers already label their devices with one or more production identifiers. As discussed in section I.B of this document, the UDI is not structured to provide direct information concerning a device; the device identifier is a reference number that allows you to find data concerning the device in an FDA database, the GUDID. Whenever this proposed rule states that a UDI “identifies” a device, we are referring to the use of the UDI in conjunction with information concerning the device that the labeler of the device has submitted to the GUDID. Universal product code (UPC) —A universal product code is an identifier used to identify a company and product name for an item sold at retail in the United States. UPCs are based on the GS1 “General Specification,” an international standard. Version or model —This definition identifies the characteristics that make a device unique. Each version or model would be required to have its own device identifier, and when you add a new version or model, or make a change that results in a new version or model, that addition or change would require use of a new device identifier and would require you to submit information concerning the version or model to the GUDID. See proposed §§ 830.50 and 830.330. The definition combines elements from definitions in the QSR for finished device and lot or batch, §§ 820.3(l) and (m), and includes language to make clear that each distinct device package (each containing a different quantity of devices) would constitute a different version or model (and would therefore have its own device identifier). 2. When would the requirement for UDI labeling go into effect, and where would the UDI have to appear? Proposed § 801.20(a) would require medical device labels and device packages to bear a UDI. Exceptions to this general rule are provided by proposed §§ 801.30, 801.35, and 801.128(f)(2), and are discussed in section II.B.7 of this document. Thus, if a device is sold in individual device packages, which are sold in boxes of five device packages, which are sold in cartons that contain ten boxes of five device packages, a UDI would be required to appear on the individual device package, on the box of five packages (which is itself a “device package,” see proposed 801.3, because it contains a fixed number of devices), and on the carton of ten boxes of five device packages (again, because the carton is a “device package”). This reflects existing practice within the health care community; both the existing GS1 and HIBCC systems, and the standards that underline those systems and the proposed FDA UDI system, follow this approach, and place an unique identifier on every distinct device package (Ref. 7). The presence of a UDI on each device package would improve the effectiveness and efficiency of recalls and other corrective actions targeting potentially harmful devices. For example, the presence of a UDI on outer packaging will enable distributors, hospitals, and others to enter it into their system upon receipt. Then they will know exactly what devices they have or had in their possession when, and if, there is a recall, tampering, counterfeiting, or other problems with the device at a later date, they can simply type in the applicable UDIs to determine whether they have (or had) the device in their possession. If there were no UDI on the outer packaging, the box or other type of container would need to be opened to access it, which could facilitate tampering and contribute to the very problems that the UDI system is designed to remedy. By requiring a UDI for device packages, the proposed UDI system strives for uniform identification of devices throughout their path of distribution and use. This will facilitate the unambiguous identification of devices wherever they are located and avoid the confusion that would be created by the use of multiple identifiers, and that would undermine the public health purposes of the rule. At present, most manufacturers generally follow this approach, and place an identifier on every device package (Ref. 7). If UDIs were not required to appear on all device packages, manufacturers would continue to use their existing identification systems, which would result in the use of multiple types of identifiers for a particular device. This would produce confusion and inhibit the rapid and precise identification of devices that is the goal of this rule. The fact that the proposed requirements are consistent with existing practices also lowers the burden of compliance. The requirement for device labels and device packages to bear a UDI would be phased in over several years: • UDI labeling requirements will take effect for class III devices and devices licensed under the Public Health Service Act beginning 1 year after we publish a final rule; see proposed § 801.20(b)(1). • UDI labeling requirements will take effect for class II devices beginning 3 years after we publish a final rule; see proposed § 801.20(b)(2). • UDI labeling requirements will take effect for class I devices and devices not classified into class I, II, or III beginning 5 years after we publish a final rule; see proposed § 801.20(b)(3) and (b)(4). See table 7 of this document for a summary of these and other effective dates proposed for this rule. Phasing in UDI labeling requirements over several years allows all parties—FDA, device labelers, hospitals and other device user facilities, and health care professionals—to prepare for, and implement, the requirements in an orderly, efficient manner. It also provides FDA the opportunity to clarify any confusion in implementation within the scope and authority of this rule, after it is finalized. We are proposing to phase in UDI labeling and data submission requirements by class because this will allow us to focus first on devices that have higher risks. Section 801.25 explains how these timeframes apply to convenience kits and combination products. The data reporting requirements of part 830 would go into effect at the same time as the UDI labeling requirements, see proposed § 830.330(a), using the same phased-in schedule as is set forth in proposed § 801.20(b). These parallel requirements—UDI labeling and data reporting—would go into effect together because, as discussed in section I.B of this document, the UDI would have limited value without the ability to look up information concerning the device in a database. 3. How would UDI labeling requirements apply to a combination product and a device constituent part of a combination product? Proposed § 801.25(a) would require a UDI on the label and device package of every combination product whose primary mode of action is that of a device, regardless of which FDA Center has been designated as having primary jurisdiction for the premarket review and regulation of the product (in the great majority of cases where the combination product has a primary mode of action of a device, the lead Center will be the Center for Devices and Radiological Health). If FDA has determined that the primary mode of action of a combination product is not that of a device, we would not require a UDI on the label or package of the combination product. For a combination product with a primary mode of action other than that of a device, we envision that the combination product generally would be identified by an NDC (see 21 CFR 201.25, 610.67; 71 FR 51276, August 29, 2006). Proposed § 801.25(b) would require a UDI on the label and (when present) the device package of each device constituent part of a combination product, regardless of the primary mode of action of the combination product, which Center has the lead responsibility for the combination product, and whether the label and package of the combination product are required to bear a UDI, except where the device constituent part is physically, chemically, or otherwise combined with other constituents of the combination product in such a way that it is not possible for the device constituent part to be used except as part of the use of the combination product; see proposed § 801.30(a)(11). Thus, whenever it is possible for a device constituent part to be used separately from a combination product with a device primary mode of action, a UDI would be required to identify the combination product, and a different UDI would be required for each device constituent part that can be used separately from the use of the combination product. This approach is necessary both for the accurate identification of the product, and to facilitate effective recalls and adverse event reporting. For example, there may be a problem with a device constituent part of a drug-device combination product that applies only to the device when it is part of the combination product, or only to the device when used separately from the combination product. We seek comments on this approach to UDI applicability to combination products. With the exception of those products where it is not possible for the device constituent part to be used except as part of the combination product, the presence of either a UDI or an NDC on the label and package of combination products, and a UDI on the label and any device package of each device constituent part thereof, would assure precise identification. 4. How would UDI labeling requirements apply to a convenience kit? A convenience kit consists of two or more different types of medical devices packaged together for the convenience of the user. We propose to require a UDI on the label of and device package of each convenience kit. See proposed § 801.25(c). We would also require each device in a convenience kit to bear its own UDI (a UDI distinct from that of the convenience kit) on its label and device package unless the included device is intended for a single use (e.g., an adhesive bandage). See proposed § 801.25(d). The reason for requiring a UDI on the label and device package of each device in a convenience kit is that devices that are intended for more than a single use, such as surgical instruments that are sometimes packaged as parts of kits, often become separated from the convenience kit, and are used at some later time. Without a UDI, there is no assurance that the user will be able to adequately identify the device and be aware of relevant data in the GUDID database concerning that device. Because this potential problem is much less of a concern for a device intended for a single use, a single-use device included in a convenience kit would not need to bear a UDI; see proposed § 801.30(a)(12). Inclusion in a convenience kit would have no effect on whether a device must be directly marked pursuant to proposed § 801.50; if § 801.50 requires the device to be directly marked, the device must be directly marked regardless of whether it is included in a convenience kit. 5. Exceptions From, and Alternatives to, UDI Labeling Requirements The proposed rule would provide several exceptions to our UDI labeling requirements. The exceptions derive from statutory provisions or are designed to make the overall UDI system more efficient and to ensure that the burdens imposed by the UDI system are reasonably balanced with its benefits. A labeler that chooses for business or other reasons to voluntarily comply with any provision from which the labeler is excepted may, of course, do so. Proposed § 801.30(a)(1) provides an exception for devices, other than prescription devices, that are sold at retail establishments, such as drug stores; this exception would also apply to such devices when sold directly to a hospital or other health care facility. A wide range of devices is available at retail, including automatic external defibrillators, insulin syringes, glucometers, tampons, thermometers, toothbrushes, bandages, and more. We are providing this exception to reduce the overall burden of the proposed rule, given that it is the prevailing industry practice to label such devices with a UPC, which may serve as an adequate substitute for devices sold over-the-counter at retail. For those labelers that choose to submit data to the GUDID on a voluntary basis, a UPC may serve as a UDI for devices sold at retail for purposes of submission of data to the GUDID; see proposed § 830.300(c). Some devices sold over-the-counter at retail have been the subject of recalls and adverse events, and we would likely see significant benefits from participation in the UDI system. It is also possible that many other devices sold over-the-counter at retail would benefit from participating in the UDI system, and that those benefits would outweigh the costs of participation. Because of our uncertainty regarding the balance of interests regarding proposed §§ 801.30(a)(1), FDA requests comments on the extent to which devices sold in retail establishments should be subject to the requirements of this proposed rule. Should these devices be excepted as provided by proposed §§ 801.30(a)(1), or should they instead be subject to the proposed rule in the same manner and to the same extent as other devices? Proposed § 801.30(a)(2) would except from UDI labeling requirements any class I device that FDA has by regulation exempted from the good manufacturing practice (GMP) requirements of part 820, the Quality Systems Regulation. If such a regulation requires that a class I device remain subject to § 820.180, with respect to general requirements concerning records, or § 820.198, with respect to complaint files, that device would nevertheless qualify for this exception. These are very simple devices, such as— • Tuning fork (product code GWX) • Elastic bandage (product code FQM) • Examination gown (product code FME) • Bedpan (product code FOB) • Manual toothbrush (product code EFW) We have provided a list of the devices that at present would be eligible for this exception; see Ref 10. FDA is providing this list to illustrate the scope of this exception at the time of this proposed rule. Proposed § 801.30(a)(3) provides an exception for individual class I, single-use devices, all of a single version or model, that are distributed together in a single package, whose uses are generally known to the persons by whom they are intended to be used, and which are not intended or promoted for individual sale. Those devices would not have to be individually labeled with a UDI. For example, this includes devices that are not individually wrapped (e.g., a box of patient examination gloves) and devices that are individually wrapped and bear identifying information, but which are not intended to be distributed individually (e.g., a box of adhesive bandages). In such cases, applying a UDI on each individual device would not be likely to contribute to better identification of the device and would be an unnecessary burden and cost. The device package containing these individual devices must, however, bear a UDI on its label. Proposed § 801.30(a)(3) would apply only to class I devices because we believe that only class I devices are currently marketed in the manner contemplated by § 801.30(a)(3). It is not our intent to require changes to current practices regarding the packaging of devices, and we are specifically seeking comment regarding this exception in question 15 of section IX of this document. Labelers of class II devices that would qualify for this exception but for their classification may request an exception or alternative under proposed § 801.35. Proposed § 801.30(a)(4) provides an exception for a device used solely for research, teaching, or chemical analysis, and not intended for any clinical use, as is consistent with FDA's general approach to the regulation of such articles as set out in 21 CFR 801.125. Proposed § 801.30(a)(5) provides an exception for a custom device, or a device made to meet the unique needs of a patient or physician, within the meaning of § 812.3(b). This exception is consistent with FD&C section 520(b), which provides that FD&C sections 514, Performance Standards, and 515, Premarket Approval, do not apply to custom devices. Because a custom device is intended only for use by an individual patient and not generally available for sale, a UDI would not be necessary to uniquely identify the device. Proposed § 801.30(a)(6) provides an exception for an investigational device within the meaning of part 812 (21 CFR part 812). Investigational devices are subject to a variety of requirements under part 812 that ensure adequate identification of the device. Proposed § 801.30(a)(7) provides an exception for a veterinary medical device not intended for use in the diagnosis of disease or other conditions in man, in the cure, mitigation, treatment, or prevention of disease in man, or intended to affect the structure or any function of the body of man. Proposed § 801.30(a)(8) provides an exception for a device intended for export from the United States. This is because foreign nations have their own regulatory requirements, which may include identification requirements, with which the device must conform. Proposed § 801.30(a)(9) provides an exception for a device held by the Strategic National Stockpile and granted an exception or alternative under § 801.128(f)(2). This exception is consistent with other labeling exceptions that apply to devices held by the Strategic National Stockpile. For background on the Strategic National Stockpile, see FDA's Interim Final Rule concerning Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile (72 FR 73601, December 28, 2007). Proposed § 801.30(a)(10) provides an exception for a device for which FDA has established a standard pursuant to section 514(b) of the FD&C Act and has provided therein an exception from the requirement of proposed § 801.20, or for which FDA has recognized all or part of a standard pursuant to section 514(c) of the FD&C Act and has included an exception from the requirement of proposed § 801.20 within the scope of that recognition. This exception is intended to provide FDA flexibility in the application of the UDI system, or an alternative, when we are using a standard as a special control for a particular device. Proposed § 801.30(a)(11) provides an exception for a device constituent part of a combination product, provided that the device constituent part of a combination product is physically, chemically, or otherwise combined with other constituents of the combination product in such a way that it is not possible for the device constituent part to be used except as part of the use of the combination product. If it is possible for the device constituent part to be used in any way except as part of the use of the combination product, this exception does not apply. See discussion under preceding question 3. Proposed § 801.30(a)(12) provides an exception for a device that is packaged in a convenience kit, provided that the device is intended for a single use. This exception does not apply if the device is intended for more than one use. See discussion under preceding question 4. Proposed § 801.30(b) provides an exception for shipping containers, because they often contain different, unrelated devices, and sometimes other items as well. We do not propose to require a UDI be placed on any shipping container, but the device packages within the shipping container would be subject to all UDI labeling requirements unless an exception applies under proposed §§ 801.30(a), 801.35 or 801.128(f)(2). Proposed § 801.30(c) provides an exception that would permit the labeler of a class I device to label it with a UDI that does not include any production identifiers; the UDI would only have to include the device identifier. Most Class I medical devices include a plain text version of relevant production identifiers (e.g., a lot number or an expiration date) somewhere on the device label. However, the cost of encoding production identifiers in dynamic barcodes for high-volume class I device production lines may outweigh the benefits of this enhanced identification. Furthermore, we believe that hospitals may be less likely to track or document individual class I device use in patient records, and are more likely to simply use a more-generic identifier; the device identifier portion of the UDI will adequately serve such needs. Labelers of class I devices are not prohibited from using a production identifier, but they would not be required to do so under this proposed rule. Proposed § 801.35 authorizes additional, case-by-case, labeling exceptions beyond those provided by proposed § 801.30; this section also authorizes alternatives to standard UDI labeling requirements. This provision is intended to ensure that the UDI system has adequate flexibility to accommodate any special circumstances regarding a particular device or type of device that indicate that application of the standard UDI labeling requirements is not technologically feasible or that the objectives of this rule would be better served by application of an alternative approach. Only a device labeler may request an exception or alternative under proposed § 801.35, although FDA may, under proposed § 801.35(d), provide an exception or alternative on our own initiative. A request for an exception or alternative under proposed § 801.35 would have to— • Identify the device that would be subject to the exception or alternative; • Identify the UDI labeling requirements that are the subject of the request for an exception or alternative; • If requesting an exception, explain why the UDI labeling requirements are not technologically feasible; • If requesting an alternative, describe it and explain how it would provide for more accurate, precise, or rapid device identification than the standard requirements or how the alternative would better ensure the safety or effectiveness of the device; • Provide an estimate of the number of labelers and the number of devices that would be affected if we grant the requested exception or alternative. See proposed § 801.35(a). We may request additional information needed to clarify the scope or effects of a request; see proposed § 801.35(a)(6). A request under proposed § 801.35 could be submitted to FDA as part of a premarket submission, proposed § 801.35(b), or through a written request at any time after a premarket submission has been filed, proposed § 801.35(c). If we grant a request for an exception or alternative, we may include conditions to ensure the adequate identification of the device through its distribution and use, given the anticipated circumstances of use. If we grant an exception or alternative, we would provide information about the exception or alternative on our Internet site. If necessary to facilitate or implement an alternative granted under this section, FDA may, at our discretion, act as an issuing agency; see proposed § 830.200(d). 6. May a device that is exempt from UDI labeling requirements nevertheless be labeled with a UDI? Yes. Proposed § 801.40(a) permits the labeler of a device that is not required to bear a UDI to voluntarily include a UDI on the label of that device. We have included this provision because it may be in the interest of both labelers and their customers to use the same identification system for all devices, and not just those devices that this rule requires to bear a UDI. If the labeler voluntarily includes a UDI on the label of a device, the labeler may also voluntarily provide information concerning the device to the GUDID; see proposed § 830.300(c). We expect most labelers who voluntarily label their devices with UDIs will choose to voluntarily submit information to the GUDID in order to facilitate the identification of those devices. 7. How would a UDI have to appear on a device label and on a device package? We would require the UDI to be provided on the device label and each device package in an easily-readable, plain-text form. This is so patients, health care professionals, FDA, and other users of the UDI system would be able to read the UDI and enter it, at their discretion, into patient records, reports to FDA, and data systems without any technological assistance. We do not specify a particular font or point size for the UDI; rather, the UDI would be subject to existing requirements that govern medical device labels, including § 801.15, concerning prominence of required label statements. The UDI would have to be provided on device labels and device packages through AIDC technology; see § 801.45(a)(2). The AIDC version will facilitate efficient and accurate identification of the device, documentation of the use of the device in electronic records, and potentially many other uses, while reducing the possibility of human error. The AIDC technology may be a bar code, RFID, near-field communications (NFC), or any other technology that serves the same objectives. We do not specify what technologies may be used, because the most appropriate technology will vary considerably depending on the type of device and its intended uses, and because the available technologies are likely to evolve and advance over time. At present, we believe most device labelers would choose to meet the requirement for AIDC technology by providing a bar code. In such instances, the bar code may be formatted in any way that meets the technical requirements of the bar coding system that is employed. While the presence of a bar code is immediately obvious, the presence of other AIDC technologies, such as RFID and near-field communication, may not be so obvious. If a device user is not aware of the availability of AIDC technology, this may impair the rapid and accurate identification of the device. To ensure that the presence of AIDC technology is obvious, if the AIDC technology is not visible on the label of the device or on the device package, the labeler would also have to include a symbol on the device label or on the device package that provides notice of the presence of AIDC technology; see proposed § 801.45(c). The symbol may be a symbol endorsed in an international or national standard recognized by FDA under section 514(c) of the FD&C Act (for example, symbols specified for differing types of RFID systems), a symbol generally recognized by the persons who typically use the device, or the generic symbol shown in proposed § 801.45(c). 8. When would a device have to be directly marked with a UDI? We restrict our proposed direct marking requirements, proposed § 801.50, to three categories of devices, because these devices present unique risks that we believe would be better controlled through direct marking: • An implantable device; • A device that is intended to be used more than once and that is intended to be sterilized before each use; and • Stand-alone software that is a “device” under § 201(h) of the FD&C Act. An implantable device, proposed § 801.50(a)(1)—An implantable device is, by definition, intended to be used for at least 30 days (see the proposed definition of implantable device at § 801.3). Once implanted, the device is separated from its label and labeling, which may prevent accurate identification of the device over time, potentially undermining the accuracy of problem reporting and delaying the identification and resolution of problems with the implanted device. But if the UDI is evident upon explantation of the device, or is retrievable through AIDC technology, it will still be possible to unambiguously identify the implant. A device that is intended to be used more than once and that is intended to be sterilized before each use, proposed § 801.50(a)(2)—These devices may also be used over an extended period of time, with the need for effective cleaning and sterilization before each new use providing a complicating factor. It is particularly important to understand precisely the identity of each such device, because effective sterilization methods may be different for different types of devices. If a device is not effectively sterilized, and is then used on a patient, severe harm may result. UDI labeling, and the associated data available from the GUDID, will help ensure device users have the information they need to avoid such harm. Stand-alone software, proposed § 801.50(a)(3)—This category excludes software that is an integrated component of a device, such as software embedded in a chip that is part of a circuit in a device. This includes stand-alone software that meets the definition of “device” under § 201(h) of the FD&C Act, e.g., prostate auto-contouring software that assists clinicians in generating estimates of the anatomy boundary contours of the prostate gland in computed tomography scans, magnetic resonance images, and ultrasound scans to aid in patient diagnosis, treatment planning, and post-treatment monitoring. Stand-alone software is unique in that it may be possible to obtain, use, and update it without ever receiving a physical package bearing a physical label. For example, software may be initially obtained via the Internet, and it is very common for patches, updates, and new versions to be provided through the Internet. Furthermore, even when the software is identical to the package and label description, it is typically used only after being installed on a computer (or multiple computers, or on a network) and typically the package and label (and the physical media, such as a CD-ROM or DVD-ROM) are no longer used. Additionally, software may be transferred from one installation to another without any external indication. All of these factors make it highly likely that users of stand-alone software will not have ready access to the package or label, or if they do, that the software differs from the label description. By requiring a simple form of direct marking as part of the software itself, we overcome these problems and ensure that users can readily and precisely identify stand-alone software. In contrast to stand-alone software, software that is a component of a device will be adequately identified by the UDI on that device's label and package. The form of direct marking that would be required depends on which of these categories the device falls within. See proposed § 801.50(c). If your device is an implantable device, or is intended to be used more than once and to be sterilized before each use, the direct marking would have to be provided through either or both of the following: • Easily-readable plain-text; • AIDC technology, or any alternative technology that will allow for identification of the device. Examples include providing the UDI of the device on demand to an external reader or sensor, or making the UDI or a barcode or other representation of the UDI discernible to an x-ray or other imaging system. If your device is stand-alone software, the direct marking would have to be provided through either or both of the following: • An easily-readable plain-text statement displayed whenever the software is started; • An easily-readable plain-text statement displayed in response to a menu command (e.g., an “About * * *” command). We seek comments about the utility of marking stand-alone software in this manner. The UDI conveyed by the direct marking may be either the UDI that appears on the label of the device, or a different UDI used to distinguish the unpackaged device from the device while it remains in packaged form. See proposed § 801.50(b). We permit the use of a different UDI to distinguish the unpackaged device because that is consistent with both current direct marking practices and the objectives of this rule. The requirement for direct marking of a device would go into effect two years after the date specified by proposed § 801.20 for the device to bear a UDI on its label; see proposed § 801.50(d). We believe this will provide the labeler adequate time to implement an appropriate direct-marking methodology for any device that would be subject to the requirements of proposed § 801.50. We seek comments on whether this is an appropriate amount of time in which to make this provisions effective. Although our proposed direct marking requirements apply only to the three categories of devices identified by proposed § 801.50(a), we recognize that even within those categories, direct marking will not always be appropriate or feasible. Proposed § 801.50(e) provides reasonable exceptions to the requirement for direct marking; direct marking would not be required when any of the following apply— • Direct marking would interfere with the safe and effective use of the device; proposed § 801.50(e)(1). For example, it is possible that direct marking would interfere with the safe and effective use of orthopedic bone screws because direct marking could adversely affect the structural integrity of the screw. Direct marking may also interfere with the safe and effective use of instruments used in arthroscopic surgery because direct marking could create irregular surfaces that could reduce the effectiveness of sterilization procedures and harbor bacteria or other pathogens. • Direct marking is not technologically feasible; proposed § 801.50(e)(2). To be technologically feasible, it must be possible to place a direct marking on the device using readily-available technology, and it must be possible for that direct marking to be read in the environments it is intended to be used, again using readily-available technology (generally meaning technologies that are typically present in the environment where the device is used). For example, it is not technologically feasible to directly mark polymethylmethacrylate (PMMA) bone cement, classified at § 888.3027, because bone cement is sold in an amorphous state. Similarly, at the present time it is not technologically feasible to directly mark an aqueous shunt, classified at § 886.3920, because the small size of the device would not permit inclusion of RFID or near-field communication, and any barcode, even if technically possible to apply, would be extraordinarily difficult to read with existing technologies. The technological feasibility of directly marking a device may change over time as new technologies are developed, enabling more direct marking options. In addition, the “not technologically feasible” exception from direct marking under § 801.50(e)(2) can include circumstances, where, for a very small firm, the capital investment in technology to allow direct part marking so exceeds to benefit of applying the requirement that FDA could find direct part marking to be “not technologically feasible.” Factors to be considered in this instance would include: The number of devices otherwise subject to direct marking across which the capital investment can be amortized, current net earnings on expected sales of such devices, and the number of years required to recover the capital investment based on net earnings. FDA believes, however, when considering whether economic factors justify an exception under the “not technologically feasible” language, FDA should retain discretion to also consider the public health benefits of direct marking for a particular device based on its usage and risks. • The device is intended to remain implanted continuously for a period of less than 30 days, unless the Commissioner determines otherwise in order to protect human health; proposed § 801.50(e)(3). This exception is inherent in the definition of implantable device, but is provided for clarity. • The device has been previously directly marked; proposed § 801.50(e)(4) We are proposing this exception both because of the practical difficulty and potential for confusion involved in applying a new direct marking when a direct marking already exists, and because multiple markings may compromise the device. We believe that continued use of the original direct marking will provide an adequate means to identify the device through its distribution and use. A labeler may, however, remark a previously-marked device if the labeler concludes, on the basis of its own evaluation, that re-marking the device would not adversely affect the safety or effectiveness of the device. • The device is sold at retail and bears a Universal Product Code (UPC); § 801.50(e)(5). • The device is software that is not stand-alone software, but is a component of a medical device; § 801.50(e)(6). Examples of a software device that is not stand-alone include software incorporated into devices such as infusion pumps and software integrated and used to control systems such as MRI machines. If you determine that your device qualifies for an exemption from direct marking, you would have to document the basis of your decision in the design history file as required by § 820.30(j) of the Quality System Regulation, see § 801.50(f). If you determine that your device qualifies for an exemption from direct marking because direct marking would interfere with the safe and effective use of the device, see proposed § 801.50(e)(1), or because you determine the device cannot be marked because it is not technologically feasible, see proposed § 801.50(e)(2), you would have to send a notice to FDA, see proposed § 801.50(g). Your notice to FDA would have to provide the following information: • Identification of the exception, or exceptions, authorized by proposed § 801.50(e) that you are invoking. • An explanation of the factors that make the exception applicable to your device. • The name of, and contact information for, the person who determined that the exception is applicable to your device. FDA does not intend to routinely respond to notices submitted under proposed § 801.50(g). If we have a question concerning your notice, we may request additional information, review information in your device history records when we conduct an establishment inspection, or take such other action as may be appropriate. 9. After the requirement for UDI labeling goes into effect, May I continue to identify my device with the National Health-Related Item Code (NHRIC) or National Drug Code (NDC) number assigned to it? No; see proposed § 801.57. FDA is phasing out the use of NHRIC and NDC numbers to identify medical devices, in favor of the UDI system. On the date your device would have to be labeled with a UDI, any NHRIC or NDC assigned to that device will be rescinded, and you will no longer be permitted to label your device with an NHRIC or NDC. Continued use of NHRIC or NDC codes on device labels and device packages would result in confusion concerning the appropriate identification of the device, and might obscure the distinction between drug and device identification systems. We seek comments on whether there are compelling reasons to continue to permit the use of these numbering systems. 10. Formatting 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, 2012). This format—Month Day, Year (SEP 30, 2012)—is the format most commonly used in the United States and is the format most familiar to patients and consumers. Dates may be printed in any size and font that meet the general labeling requirements of part 801. When dates are formatted to use only numbers, inconsistencies in formatting from one device to another can lead to confusion concerning the proper interpretation of the date. For example, the expiration date January 12, 2013 may, at present, be expressed as 1-12-2013 (this is the format most commonly used in the United States) or as 12-1-2013 (this is the format most commonly used in Europe). This could cause a patient or a health care professional to mistakenly continue to use the device for more than 10 months past the intended expiration date. Another source of potential confusion is the use of date formats that use only the month and year, such as 12-2011, 12-11, or December 2011. The omission of the precise day of the month creates uncertainty; 12-2011 could indicate that use of the device should cease on the first day of December 2011, or the last day of December 2011. Furthermore, when a date uses a two-digit representation of year, it may not be clear that the number sequence represents a date. Use of a standard format consistent with the usage most often used and most readily recognized by consumers in the United States will eliminate any potential confusion concerning the appropriate interpretation of dates provided on medical device labels. (Ref. 8) The proposed date format may contribute to more accurate identification of a device by making it possible to distinguish between those devices that have passed an expiration or use-by date and those that have not. More accurate identification would make it easier to both avoid the risks of using “expired” devices and the costs of premature disposal of devices that have not actually reached an expiration or use-by date. We provide a limited exception in proposed § 801.18(f) for electronic products to which a standard is applicable under subchapter J, Radiologic Health; 21 CFR 1010.3(a)(2)(ii) specifies the date format for such electronic products. We do not believe it is necessary to change this requirement for these products, because that standard uses the month and year of production, which does not involve the potential for confusion that an expiration date or use-by date may present. Proposed § 801.18 would go into effect one year after we publish a final rule. We believe § 801.18 should be implemented as rapidly as possible because it is designed to correct existing confusion concerning the interpretation of dates on medical device labels. We seek comments on whether this date format and associated effective date are feasible and appropriate, including whether the effective date should be linked to the UDI implementation date for each class of devices. C. Requirements Relating to Issuing Agencies and Submission of Data to the Global Unique Device Identification Database (Part 830) New part 830 would provide FDA's requirements for the composition and issuance of UDIs, explain the process FDA would follow to accredit an “issuing agency” to operate a system for the issuance of UDIs, explain when FDA would act as an issuing agency, and would provide requirements pertaining to the GUDID, including when and what data must be submitted to the GUDID and by whom. 1. Definitions We are proposing, in new § 830.3, definitions for important terms used by FDA's unique device identification system under this rule. The terms proposed for inclusion in § 830.3 are discussed in this section II.C; where a term is also defined in part 801, the definitions are identical. The following terms would have the same definition in both parts 801 and 830; these terms are discussed earlier in this preamble— • Automatic identification and data capture (AIDC). • Device package. • Expiration date. • FDA, we, or us. • Labeler. • Lot or batch—This definition includes a definition of finished device. • Specification. • Shipping container. • Unique device identifier (UDI). • Universal product code (UPC). • Version or model. The following additional terms are defined in proposed § 830.3— Issuing agency— This term would mean an organization accredited by FDA to operate a system for the issuance of UDIs. Our proposed rule permits multiple issuing agencies, and under certain circumstances FDA could act as an issuing agency. Global Unique Device Identification Database or GUDID —This term would mean the FDA-administered database that serves as a repository of information to facilitate the identification of medical devices through their distribution and use. The device identifier portion of a UDI would not be structured to provide specific information concerning a device; rather, the device identifier would serve as a reference number that would allow you to find information about the device by accessing info [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2012-16621. Public record. Not legal advice.