A comment that was primarily concerned with medical procedure kits (discussed later in this document) suggested FDA should provide definitions for "set," "kit," "tray," and "pack."
The final rule provides definitions for convenience kit and device package. We do not believe the additional definitions are needed, and we believe section II. M., "Medical Procedure Kits and Trays" provides adequate information for a reader to understand how these items are regulated under the final rule.
Because FDA does not agree that any of the suggested additional terms need to be defined for an understanding of this rule, the final rule includes only one additional term that was not included in our July 10, 2012, proposed rule: "HCT/P regulated as a device", which is discussed previously.
B. Applicability of SEC 801.20
There were a number of comments regarding the applicability of the UDI requirements of SEC 801.20 to combination products with a device constituent part, convenience kits, in vitro diagnostic products, and HCT/Ps regulated as devices.
These products are devices, contain devices, or are regulated as devices, and are therefore subject to the requirements of this rule.
C. Compliance Dates of Unique Device Identifier Regulatory Requirements
FDA received many comments (approximately 100) suggesting changes to the compliance dates we proposed in our July 10, 2012, proposed rule and November 19, 2012, amended proposed rule (mistakenly referred to as "effective dates" in the proposed rule and amended proposed rule). Roughly one-third of the comments that expressed a specific view recommended a more rapid implementation of the rule's requirements in order for the rule's benefits and goals to be more rapidly achieved; for example, these comments suggested the proposed phased implementation timeframe is "far too long," that the rule's requirements should go into effect "quickly--not years from now," and that "UDI needs to be implemented as quickly as possible." Roughly two-thirds recommended FDA allow more time in order to better manage the tasks required to meet the rule's requirements and to spread the costs of implementation over a longer period of time; for example, these comments suggested that FDA should "reconsider the schedule for implementation . . . as some of the defined time periods are not possible for companies that may have thousands of products containing various levels of packaging," and that "the proposed effective dates [meaning compliance dates] do not allow adequate time to prepare to meet the rule's requirements."
Several comments suggested that the compliance date of SEC 801.18 should be tied to the date the device must bear a UDI on its label; for example, a comment suggested that the compliance date of SEC 801.18 should be "aligned with the date the label of the device must bear a UDI."
FDA agrees with these comments, and we have established a set of compliance dates that are the same for SEC 801.18 and the rule's UDI labeling requirements. This avoids the need to change a device label more than once to implement the rule's requirements. We discuss the comments on SEC 801.18 and provide a full response in section II.D, "Formatting of Dates Provided on Medical Device Labels-- SEC 801.18."
Section VII.B, "Compliance Dates," explains the compliance dates FDA has established for this and other provisions of the final rule. This section makes clear that the requirements of the rule apply to devices put in commercial distribution after the applicable compliance date, and not to devices put in commercial distribution prior to such date. As discussed in section II.A in the context of the definition of "labeler," commercial distribution is defined at SEC 807.3(b) and the same meaning applies here.