Source: https://regulatorydoctor.us/davidlim-unique-device-identification-udi/
Timestamp: 2019-04-22 15:18:48+00:00

Document:
The following shows a list of UDI compliance dates and changes made in the UDI final rule.
1 year after publication of the final rule (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. § 801.20. Dates on the labels of these devices must be formatted as required by § 801.18. Data for these devices must be submitted to the GUDID database. § 830.300. A 1-year extension of this compliance date may be requested under § 801.55; such a request must be submitted no later than June 23, 2014. Class III stand-alone software must provide its UDI as required by § 801.50(b).
2 years after publication of the final rule (September 24, 2015 ) The labels and packages of implantable, life-supporting, and life-sustaining devices must bear a UDI. § 801.20. Dates on the labels of these devices must be formatted as required by § 801.18.
A device that is a life-supporting or life-sustaining 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. § 801.45. Stand-alone software that is a life-supporting or life-sustaining device must provide its UDI as required by § 801.50(b).
Data for implantable, life-supporting, and life-sustaining devices that are required to be labeled with a UDI must be submitted to the GUDID database. § 830.300.
3 years after publication of the final rule (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. § 801.45.
The labels and packages of class II medical devices must bear a UDI. § 801.20. Dates on the labels of these devices must be formatted as required by § 801.18. Class II stand-alone software must provide its UDI as required by § 801.50(b).
5 years after publication of the final rule (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. § 801.45.
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. § 801.20.
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. § 830.300.
7 years after publication of the final rule (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. § 801.45.
Compliance dates for all other provisions of the final rule. Except for the provisions listed in this table, FDA requires full compliance with the final rule as of the effective date that applies to the provision.
The proposed rule used the term “effective date” in an incorrect manner when denoting the dates by which a labeler would have to comply with certain provisions. A consequence of setting an effective date for a particular requirement is that the requirement will not be published in the Code of Federal Regulations (CFR) until the effective date has passed. This would have made it very difficult for labelers to understand and comply with the final rule, for example because the CFR would not have provided the full text of the regulatory requirements of a final rule for several years. The proposed rule should have used the term “compliance date” to indicate when a labeler would not be required to comply with certain provisions The final rule uses “compliance date” to explain when a labeler is required to comply with a regulatory requirement. The final rule has only two effective dates: The final rule is effective 90 days after publication (December 23, 2013), except §§ 801.55, 830.10, 830.100, 830.110, 830.120, and 830.130 are effective 30 days after publication (October 24, 2013). To clarify changes from the proposed rule to the final rule, we use the term “compliance date” throughout this document wherever the proposed rule incorrectly used “effective date.” Section VII.B., “Compliance Dates,” explains in detail the compliance dates FDA has established for the final rule. A device does not have to comply with the final rule if it is in commercial distribution, see § 807.3(b) (21 CFR 807.3(b)), prior to the applicable compliance date.
The proposed rule did not explain how it would apply to inventories of devices manufactured and labeled prior to the compliance date of the final rule 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. See § 801.30(a)(1).
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). Proposed § 801.18 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., 2013-09-30). This format is consistent with international standards and the requirements of the European Union and other nations. See § 801.18.
The proposed rule would have provided an exception from UDI labeling requirements for a device, other than a prescription device that is made available for purchase at a retail establishment, including such a device delivered directly to a hospital, ambulatory surgical center, nursing home, outpatient treatment facility, or other health care facility. Proposed § 801.30(a)(1) The final rule provides that a class I device labeled with a Universal Product Code (UPC) may use the UPC as its UDI; see § 801.40(d).
The proposed rule would have required certain combination products, and certain device constituent parts of every combination product, to bear a UDI on their label. Proposed § 801.25(a) and (b) The final rule excepts the device constituent part packaged within a combination product from the requirement that its label bear a UDI, if the combination product bears a UDI. § 801.30(a)(11).
The proposed rule would have required the label and device package of each device packaged in a convenience kit to bear its own UDI, distinct from that of the convenience kit, unless intended for a single use. Proposed § 801.25(d) The final rule does not require devices contained within a convenience kit to bear a UDI but does require the label and each device package of every convenience kit to bear a UDI. § 801.30(a)(11).
The proposed rule would have provided an exception for a class I device that FDA has by regulation exempted from the good manufacturing practice requirements of part 820. Proposed § 801.30(a)(2) The final rule provides an exception for a class I device that FDA has by regulation been exempted (but for the continuing requirement for recordkeeping under §§ 820.180 and 820.198) from the good manufacturing practice requirements of part 820 of this chapter. See § 801.30(a)(2).
The proposed rule would have provided an exception for individual class I single-use devices (SUDs), all of a single version or model, that are distributed together in a single device package, and which are not intended for individual sale. Proposed § 801.30(a)(3) The final rule extends this exception to all individual SUDs, regardless of class, except that this exception is not available for any implantable device. The device package containing these individual devices is not excepted, and must bear a UDI. See § 801.30(a)(3).
The proposed rule would have provided an exception for a device constituent part of a combination product, if 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 it to be used except as part of the use of the combination product. Proposed § 801.30(a)(11) The final rule provides that a device packaged within the immediate container of a combination product is excepted from the requirements of § 801.20 if the combination product bear a UDI.
The proposed rule would have required a combination productfor which the primary mode of action is that of a medical deviceto bear a UDI on its label. Proposed § 801.25(a) The final rule also makes clear that the device constituent of a combination product whose components are physically, chemically, or otherwise combined or mixed and produced as a single entity as described by § 3.2(e)(1) (21 CFR 3.2(e)(1)) is not subject to the requirements of § 801.20 if the combination product properly bears a National Drug Code (NDC) number. See § 801.30(b)(2). The final rule provides that a combination product that properly bears a National Drug Code (NDC) number is not required to bear a UDI. See § 801.30(b)(1). However, the final rule also makes clear that each device constituent of a combination product, other than one described by § 3.2(e)(1), that properly bears an NDC on its label must also bear a UDI on its label unless the combination product bears a UDI on its label. See § 801.30(b)(3).
The proposed rule would have provided an exception for a device that is packaged in a convenience kit, provided thatthe device is intended for a single use. Proposed § 801.30(a)(12) The final rule broadens and simplifies this exception, and extends it to the label of any device that is packaged in a convenience kit as long as the label of the convenience kit bears a UDI. See § 801.30(a)(11).
The proposed rule would have required use of a symbol to indicate the presence of AIDC technology, and provided a generic symbol that could have been used in lieu of any other symbol. Proposed § 801.45(c) The final rule renumbers proposed § 801.45 as § 801.40. The final rule does not require use of a symbol to indicate the presence of AIDC technology, no longer provides for use of a generic symbol, and instead requires only that a label “disclose” the presence of AIDC technology. See § 801.40(c).
The proposed rule would have required an implantable device required to bear a UDI on its label to also bear a permanent marking providing the UDI. See proposed § 801.50(a)(1) This provision has been removed; an implantable device will not be required to be directly marked with a UDI.
The proposed rule would have required a device required to bear a UDI on its label to also bear a permanent marking providing the UDI if the device is intended for more than one use and must be sterilized before each use. See proposed § 801.50(a)(1) The final rule renumbers proposed § 801.50 as § 801.45. The final rule changes this provision to apply to devices that are “reprocessed” before each use; this broadens the scope of the provision. See § 801.45(a)(1).
The proposed rule did not fully explain how UDI labeling requirements would apply to stand-alone software regulated as a medical device. Proposed § 801.50, concerning direct marking, was the only provision that specifically addressed stand-alone software The final rule includes a new section that provides special labeling requirements for stand-alone software regulated as a medical device, including: • An explanation of how stand-alone software can meet UDI labeling requirements when it is not distributed in package form (e.g., when it is downloaded from a labeler’s Web site); • a requirement for all stand-alone software to include means of displaying its UDI; and • an explanation that stand-alone software that is distributed in both packaged form and in a form that is not packaged (e.g., when downloaded from a Web site) may be identified with the same device identifier. See § 801.50.
The proposed rule was not clear regarding the process for requesting an exception or alternative to some UDI labeling requirements, and provided one process for requests that concern the use of UDIs on a device label and device package, proposed § 801.35, and an entirely different process concerning direct marking of medical devices, proposed § 801.50 The final rule provides a single process for all types of requests, and provides a more comprehensive process. See § 801.55. The final rule adds these provisions: • FDA may grant a 1-year extension of the compliance date applicable to class III devices and devices licensed under the Public Health Service Act; see § 801.55(b), discussed previously; • FDA may initiate and grant an exception or alternative if we determine that the exception or alternative is in the best interest of the public health; see § 801.55(e); • FDA may rescind an exception or alternative; see § 801.55(e); • any labeler may make use of an exception or alternative that FDA has granted (FDA plans to make all decisions available to the public on FDA’s Web site); see § 801.55(d).
The proposed rule was unclear whether the discontinuation of legacy FDA identifiers for devices (National Health-Related Item Code (NHRIC) and NDC numbers) would apply to devices that are exempted from UDI labeling requirements. Proposed § 801.57 The final rule explains that every NHRIC and NDC number assigned to any device (even a device that is not required to bear a UDI) will be rescinded no later than September 24, 2018. See § 801.57.
The proposed rule did not explain how the discontinuation of legacy FDA identifiers would affect FDA-issued labeler codes that are already in use in the private sector and whose use might be permitted under an FDA-accredited system for the issuance of UDIs The final rule will permit continued use of an FDA-issued labeler code under an FDA-accredited system for the issuance of UDIs, provided that such use is permitted by the issuing agency that administers that system, and provided the labeler submits a request for continued use of a labeler code; FDA must receive the requestno later than September 24, 2014. See § 801.57(c).
The proposed rule did not require information concerning magnetic resonance imaging (MRI) compatibility of a device to be submitted to the GUDID. See proposed § 830.310(b) The final rule requires information to be submitted to the GUDID concerning whether a patient may be safely exposed to MRI or similar technologies while using the device or while the device is implanted in the patient. See § 830.310(b)(8).
The preamble to the proposed rule stated that the GUDID would not collect the Global Medical Device Nomenclature (GMDN) code for a device under proposed § 830.310(b) unless GMDN codes were made freely available The GMDN Agency has agreed to provide free access to GMDN nomenclature within the context of the GUDID data submission process. A labeler who reports data to the GUDID will be able to enter a GMDN code if the labeler knows it, or may use a module integrated in the GUDID reporting system to search for and select an appropriate GMDN term. See § 830.310(b)(13).
The proposed rule did not explain the process for correcting misinformation submitted to the GUDID The final rule explains that FDA may inform the labeler that information submitted to the GUDID appears to be incorrect or potentially misleading, and request that the labeler correct the information or provide a satisfactory explanation of why it is correct. The labeler would have 10 days to correct the information or explain why it is correct. If FDA determines that information is incorrect or could be misleading, we may delete or replace the information. See § 830.350.

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