American Association of Tissue Banks: Impact on FDA s UDI Final Rule

Transcription

1 American Association of Tissue Banks: Impact on FDA s UDI Final Rule TOPIC INITIAL FDA PROPOSAL AATB COMMENT FDA FINAL RULE (INCLUDING COMMENTS) ISBT 128 FDA noted the presence of GS1 [which uses the Global Trade Identification Number (GTIN) and the Universal Product Number (UPN)] and the Health Industry Business Communications Council (HIBCC) [which uses the Health Industry Bar Code (HIBC)]. Recommended that FDA formally acknowledge ISBT 128 as part of the menu of options for the UDI, especially for devices derived from human tissue, if FDA is going to require such products to have a UDI. In discussing the potential issuing agencies, FDA notes that [t]hree existing organizations now perform functions similar to those of an issuing agency under the final rule, as part of the analysis of the impact. However, FDA does not specifically mention ISBT 128 in the final rule but rather relies upon a process for certifying an issuing agency. Adverse events A goal of the UDI is providing for more rapid identification of medical devices with adverse events. Requested that the FDA and the AATB host a joint workshop to further develop methodologies for examining adverse events as they are reported to provide greater clarity regarding the process by which an adverse event report may lead to a potential recall. FDA did not respond directly to the request for a workshop. Date format Direct marking Dates provided on device labels would have been presented as Month Day, Year, using a three letter abbreviation of the month (e.g., SEP 30, 2013). FDA outlines three categories of devices that must have direct marking, including implantable devices. FDA further acknowledged, even within those categories, direct marking will not always be appropriate or feasible. Then FDA outlines several reasonable exemptions to the requirement for direct marking, including direct marking would interfere with the safe and effective use of the device. Recommended that FDA adopt the globally recognized and standardized date format consisting of all numbers (i.e. 2012/10/24) to avoid confusion and the need for translation of the English month into multiple foreign languages. Direct marking is not possible due to interference with the safe and effective use of the device and physical characteristics of tissue derived devices. Encouraged the FDA to provide such a broad exemption for devices derived from human tissue and not require each tissue bank to file a notice under section (g) for each device. FDA agreed with AATB s recommendation. Dates provided on device labels are to be presented as Year Month Day, with the year expressed as four digits, the month expressed as two digits, and the day expressed as two digits (e.g., ). This format is consistent with international standards and the requirements of the European Union and other nations. FDA agreed with AATB s comments and opted to eliminate the requirement that an implantable device be directly marked with a UDI.

2 Concerns with the lot/batch designation Bulk label/ Device package Custom devices Protection of Commercial Information Submitted to GUDID 820.3(m) defines lot or batch as one or more components or finished devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits. Devices derived from human tissue cannot be labeled by lot or batch, unless the lot or batch identification is associated with a single donor, as (b) disallows the pooling of human cells or tissue from two or more donors during manufacturing. FDA proposes a specific label for a device package (package that contains a fixed quantity of devices) and invites comments on that practice. FDA provides some exemptions from the UDI requirements for (1) a custom device, or a device made to meet the unique needs of a patient or physician; and (2) a device intended for export from the United States. Section II.C.16 states that [w]e have determined that none of the information that would be required to be submitted [to the GUDID] under this rule would constitute trade secret, confidential commercial information, or personal privacy information, or would otherwise be prohibited from public release. Cannot rely on FDA specific terms such as lot/batch or date of manufacture. Any bulk label could only apply to devices from a single donor. Acknowledgement that some tissue implants regulated as devices should be exempt from the UDI requirements. Urged FDA to revise the proposed rule to maintain the confidentiality of the number of medical devices manufactured by a given manufacturer. FDA agrees that these are valid concerns, but we believe that the phrases "manufactured under essentially the same conditions" and "intended to have uniform characteristics and quality within specified limits" in the definition of lot or batch are flexible enough to include the distinct identification code required by (c). FDA has, however, addressed the concerns of these comments in another way. To clearly accommodate HCT/Ps regulated as devices, the final rule includes additional language in the definition of production identifier (part of the definition of unique device identifier). A production identifier is defined as a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of the device: (i) The lot or batch within which a device was manufactured; (ii) The serial number of a specific device; (iii) The expiration date of a specific device; (iv) The date a specific device was manufactured; (v) For an HCT/P regulated as a device, the distinct identification code required by (c) of this chapter. FDA stated that the device package would need to have a UDI, even it contained a HCT/P. In addition, to accommodate HCT/Ps regulated as devices, the final rule includes additional language in the definition of production identifier (part of the definition of unique device identifier), as outlined above. FDA agreed to maintain the exemption and further noted that FDA intends the custom use exception of the final rule to be available only for devices within the meaning of 812.3(b). FDA disagrees. Labelers are required to report only the type of production identifiers that appear on the label of the device to the GUDID, which would not reveal the number of devices manufactured. FDA does not believe any of the information required to be reported to the GUDID, most of which appears on the label of the device, would constitute trade secret or confidential commercial information. Prepared by Hart Health Strategies, 09/24/13 Page 2

3 Changes that Result in New Version or Model Definitions Relabeling of current inventory Convenience Kits The proposed rule (a) is written so that any specification change would require a new version. Included a series of definitions for the final rule. Requires that any product shipped in interstate commerce after the effective date of the regulation for the particular class of device would bear the UDI. UDI labeling requirements would apply to convenience kits and devices included in a convenience kit, except for a single use device. Convenience kit is defined as 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 Recommended that all specification changes are reviewed and an assessment against (c) that states that any change that could significantly affect the safety and effectiveness of the device requires a new version/udi. Urged the FDA to include in the final rule only new definitions that have been created as part of UDI, given that over half of the definitions have misalignment with existing regulations and/or industry standards. Due to the accelerated implementation timeline described in the November 19 Federal Register notice, it is even more critical that FDA allow existing inventory on consignment to remain on consignment without UDIs. All cryopreserved medical devices are implantable, and therefore subject to the accelerated implementation timeline described in the November 19 Federal Register notice. It is therefore even more critical that FDA allow existing inventory of cryopreserved medical devices, regardless of location, to be distributed without UDIs. Requested the final rule include an exception for all medical devices that have been manufactured prior to the issue of the final rule. The final rule should apply to all products released for distribution (including consignment) on or after each effective date of the final rule. Requested removal of all references to convenience kits. FDA acknowledged the concern. The final rule gives labelers more flexibility to determine when a change to a device will require use of a new UDI is now entitled "Changes that require use of a new device identifier." If the labeler makes a change to a device that is required to bear a UDI on its label, and determines that the change results in a new version or model, the labeler must assign a new device identifier to that device and to all associated device packages. FDA did not specifically address this comment, although FDA did make changes to certain definitions to try to align with current industry practices. FDA agreed with the comment and acknowledged the key issue of relabeling for HCT/Ps. The final rule provides an exception for a finished device that is manufactured and labeled prior to the compliance date that applies to that device, but the exception expires 3 years after the compliance date that applies to the particular device. FDA recognizes that there may be rare and unusual circumstances where the limited period provided by this exception might be problematic. For example, it may not be possible to relabel a particular cryopreserved HCT/P regulated as a device held in inventory longer than 3 years to add a UDI without damaging the HCT/P. In such rare and unusual circumstances, FDA may exercise enforcement discretion to permit continued distribution of a device, particularly if a device shortage would be likely if we rigorously enforced the UDI labeling requirements upon expiration of the exception period. Any manufacturers who are currently aware of the need for a longer period of time than is afforded by this rule to deplete existing inventory are encouraged to contact FDA. FDA does not agree that convenience kits should be excluded from the final rule. Convenience kits are in wide use and are medical devices in their own right, apart from their constituent devices; their exclusion would leave a significant gap in the coverage of the rule and would undermine the effectiveness of the UDI system because they are controlled in the supply chain Prepared by Hart Health Strategies, 09/24/13 Page 3

4 Request for a UDI exemption for all HCT/Ps convenience kit would have to have a UDI; see proposed (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. 21 CFR 1271 requires that each HCT/P be assigned and labeled with a distinct identification code to facilitate tracking. This code must relate the HCT/P to the donor and to all records pertaining to the tissue. The code must enable effective tracking from the donor to the receiving facility (consignee) and from the consignee to the donor. The UDI system does not take into consideration the importance of, and need for donor information. When finalized, the Association recommends that HCT/Ps, including those not regulated solely under section 361 of the Public Health Service Act ( ) and those whose primary mode of action is that of a device, be exempted from the UDI Final Rule. by the kit rather than by constituent part. FDA removed proposed from the final rule but only because convenience kits are by definition devices and therefore are required to meet UDI requirements. However, FDA does include an exception for the label of devices contained within the immediate container of a convenience kit at (a)(11). The final rule adopts the definition of convenience kit provided by the proposed rule, without change. The final rule does, however, include important changes that FDA believe address the underlying concerns of these comments. Section (a)(11) now provides that the label of devices packaged within the immediate container of a convenience kit do not have to bear a UDI as long as the label of the convenience kit bears a UDI. This change will make clear that labelers do not have to change the way they label convenience kits, including in vitro diagnostic kits, except for including a UDI on the kit label. FDA disagreed with the comment. FDA is not providing a narrowly targeted exception for any of these devices in the final rule for two reasons. First, the final rule includes significant changes to , which provides certain categorical exceptions from the requirement for the label of a device to bear a UDI, and to other provisions that may be relevant to the concerns expressed in the comments that request additional exceptions. Second, the information provided by these requests and comments varied considerably in scope and detail, and none provided sufficient information to justify an FDA decision to except a category of devices from any UDI requirement. FDA believes it is more appropriate for all requests involving an exception or alternative to UDI requirements that do not fit into the categorical exceptions of the final rule to be evaluated through the revised process provided by of the final rule. Section of the final rule builds on proposed , but has been revised and has expanded the circumstances under which an exception from or an alternative to a UDI requirement may be requested or granted. If after reviewing the changes made in the final rule a person who requested an exception or alternative in a comment on the proposed Prepared by Hart Health Strategies, 09/24/13 Page 4

5 GUDID comment period GUDID Crossreferencing multiple UDIs Stakeholders were not able to comment on the specific details of each attribute to be required in the GUDID. Did not address cross referencing. Please publish the proposed attributes, make them available for comment prior to issuing the final rule, and take stakeholder comments into consideration. The GUDID development effort should include the goal of connecting to developing device registries, and the phasing in of the GUDID items should also be linked with the phasing in of the device registries. Please consider the United Kingdom's National Joint Registry (NJR), in particular, which seems pretty sensible with regards to the levels of information to be entered by the manufacturer and healthcare provider/facility. Recommended that the GUDID support crossreferencing multiple UDIs for a given device from different issuing agencies. rule still believes that some type of exception or alternative is required, we invite that person to submit a request under , and to ensure that the request provides the information required by (a). FDA opted in lieu of additional rulemaking on the GUDID to issue guidance instead. FDA noted that the general approach has been to regard a comment that did not suggest the need for a change to the regulatory language as being a request for guidance. FDA will consider all such comments as FDA develops guidance concerning the final rule and the GUDID, and FDA plans to provide information concerning functions of the GUDID. FDA opted in lieu of additional rulemaking on the GUDID to issue guidance instead. GUDID Database compliance issues The proposed rule requires that within one year of the effective date of the final rule, each manufacturer of Class III medical devices will have populated the GUDID with all of its Class III medical devices. The timeline for Class II medical devices that are implanted, life sustaining or life supporting has been accelerated from three to two years. Requested that the FDA push the deadline for compliance out to at least 5 years from the effective date: 5 years for Class III devices, 7 years for Class II devices, etc. FDA did not agree with any comment that sought broad changes to the proposed timeframes for implementation of UDI labeling or GUDID reporting requirements. FDA believes the schedule laid out in the amended proposed rule not only meets the statutory requirements of FDASIA, but also strikes a realistic balance between desires to quickly see benefits from the UDI system and the challenges that must be met to design, deploy, and test the systems that will be required to meet the new regulatory requirements and for effective and efficient administration of UDI processes. FDA also continues to believe that the implementation timeframe should be tied to the risk of the device. Consequently, FDA is establishing compliance dates as proposed in the amended proposed rule, except for the change in the compliance date of to coincide with the date a device must bear a UDI on its label. Prepared by Hart Health Strategies, 09/24/13 Page 5

6 Accelerated timeframes September 24, 2014 = The labels and packages of class III medical devices and devices licensed under the Public Health Service Act (PHS Act) must bear a UDI Dates on the labels of these devices must be formatted as required by Data for these devices must be submitted to the GUDID database September 24, 2015 = The labels and packages of implantable, life supporting, and lifesustaining devices must bear a UDI Dates on the labels of these devices must be formatted as required by A device that is a life supporting or lifesustaining device that is required to be labeled with a UDI must a bear UDI as a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use Stand alone software that is a life supporting or life sustaining device must provide its UDI as required by (b). Data for implantable, life supporting, and lifesustaining devices that are required to be labeled with a UDI must be submitted to the GUDID database September 24, 2016 = Class III devices required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use The labels and packages of class II medical devices must bear a UDI Dates on the labels of these devices must be formatted as required by Class II stand alone software must provide its UDI as required by (b). Data for class II devices that are required to be labeled with a UDI must be submitted to the GUDID database The accelerated timeframe for the UDI as well as submission to the GUDID database is particularly problematic for several tissue products. While the revision to the proposed rule would have no effect on class III devices, class II, class I, and unclassified devices would have a muchaccelerated timeframe for implementation. Class II implantable, life supporting and life sustaining devices would have to bear a UDI on the label and device package and submit data to the GUDID one year earlier than first proposed. For class III or unclassified devices that are implantable, lifesupporting and life sustaining, such devices would have to bear a UDI on the label and device package and submit data to the GUDID 3 years earlier than first proposed. While AATB understands that the proposed revision is intended to comply with Congressional intent to accelerate timeframes for implantable devices, the AATB strongly encourages the FDA to make Congress aware of the potential untoward effect of this change and use the statutory flexibility granted regarding patient access, especially as it relates to implantable devices which are class II or unclassified devices. FDA did not agree with any comment that sought broad changes to the proposed timeframes for implementation of UDI labeling or GUDID reporting requirements. FDA believes the schedule laid out in the amended proposed rule not only meets the statutory requirements of FDASIA, but also strikes a realistic balance between desires to quickly see benefits from the UDI system and the challenges that must be met to design, deploy, and test the systems that will be required to meet the new regulatory requirements and for effective and efficient administration of UDI processes. FDA also continues to believe that the implementation timeframe should be tied to the risk of the device. Consequently, FDA is establishing compliance dates as proposed in the amended proposed rule, except for the change in the compliance date of to coincide with the date a device must bear a UDI on its label. Prepared by Hart Health Strategies, 09/24/13 Page 6

7 September 24, 2018 = A class II device that is required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use The labels and packages of class I medical devices and devices that have not been classified into class I, class II, or class III must bear a UDI Dates on the labels of all devices, including devices that have been excepted from UDI labeling requirements, must be formatted as required by Data for class I devices and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI must be submitted to the GUDID database Class I stand alone software must provide its UDI as required by (b). September 24, 2020 = Class I devices, and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI, must a bear UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use Prepared by Hart Health Strategies, 09/24/13 Page 7