Several comments suggested several changes to the timeframes proposed in our July 10, 2012, proposed rule and our November 19, 2012, amended proposed rule. The specific changes suggested varied considerably. For example, comments suggested several different ways to implement the requirements for UDI labeling and GUDID reporting. Comments suggested that all devices should be subject to these requirements within 2 years, or 3 years. Other comments suggested that class II devices should be subject to these requirements after 3 years, or 5 years, or 7 years; that class III devices should be subject to these requirements after 1 year, or 2 years, or 3 years, or 5 years; that class I devices should be subject to direct marking requirements after 5 years instead of 7 years. A comment suggested that the implementation timeframe be tied to each issuing agency's "establishment and communication of processes to support the . . . Rule." We also received comments that simply recommended we implement the rule's requirements more quickly, or to allow more time for implementation, or to provide "adequate" time, but without suggesting specific timeframes. One comment suggested that if the compliance dates were not delayed "for several years," the rule should be reproposed. Other comments agreed that the phased in implementation proposed by FDA would minimize the burdens. A comment stated that the proposed timeline for implementation of direct marking requirements is "reasonable and necessary," and another comment agreed that it is reasonable to require submission of GUDID data on the date a device must bear a UDI on its label.
Some comments were particularly concerned about requirements that would apply 1 year after publication of a final rule--The date formatting requirements of SEC 801.18 and the requirements for UDI labeling and GUDID reporting for class III devices. The comments concerning SEC 801.18 are discussed previously. Several comments concerning the compliance dates for class III devices requested more time; for example, a comment stated that the compliance date for class III devices "should be extended to 2 years from the date the rule is finalized" because the proposed 1-year timeframe "may not allow enough time for manufacturers to comply with the UDI requirements if their product portfolio contains a large number of those products." Other comments stated that revision of labeling "will be extensive and time consuming," that labelers will need more time "for the preparation and submission of device related data," and that the "timeframe . . . for class III device manufacturers to submit . . . data to the GUDID is too short. We believe the deadline . . . should be extended an extra year."
In summary, while many comments wanted some change to the implementation schedule proposed by FDA, there were many different views concerning the precise timeframe those changes should take effect. Some comments recommended that labelers should be allowed to comply with the date formatting requirements of SEC 801.18 and basic UDI labeling requirements (labeling requirements other than direct marking) on the same date. On this latter comment, FDA agrees, as discussed in more detail in this document.
However, FDA does not agree with any comment that seeks broad changes to the proposed timeframes for implementation of UDI labeling or GUDID reporting requirements. Overall, we believe 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 our amended proposed rule, except, as discussed previously, we have changed the compliance date of SEC 801.18 to coincide with the date a device must bear a UDI on its label.