Source: https://www.federalregister.gov/documents/2012/11/19/2012-28015/unique-device-identification-system?source=govdelivery
Timestamp: 2017-05-29 11:29:08
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:: Unique Device Identification System
A Proposed Rule by the Food and Drug Administration on 11/19/2012
69393-69399
A. FDA's July 10, 2012, Proposed Rule
Enhanced Content - Submit Public Comment 262
https://www.federalregister.gov/d/2012-28015
The Food and Drug Administration (FDA) is amending its July 10, 2012, proposed rule (77 FR 40736) to establish a unique device identification system as required by recent amendments to the Federal Food, Drug, and Cosmetic Act (the FD&C Act). On July 9, 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law; section 614 of FDASIA amends the FD&C Act in ways that require modification of the timeframe for implementation of the proposed rule's requirements as they apply to devices that are implantable, life-saving (life-supporting), or life-sustaining.
You may submit comments, identified by Docket No. FDA-2011-N-0090 and/or RIN Number 0910-AG31, by any of the following methods.
Section 614 of FDASIA amends section 519(f) of the FD&C Act, the provision that requires FDA to establish a unique device identification system. Prior to the enactment of FDASIA, section 519(f) of the FD&C Act did not specify the date by which a proposed rule is required, did not identify any particular devices as requiring expedited implementation of UDI requirements, and did not specify timeframes for publication of a final rule. The FDASIA amendments to section 519(f) address each of those points. As amended by FDASIA, section 519(f) of the FD&C Act now requires that not later than December 31, 2012, the Secretary shall issue proposed 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. Section 519(f) of the FD&C Act also requires that the Secretary shall finalize the proposed regulations not later than 6 months after the close of the comment period and shall implement the final regulations with respect to devices that are implantable, life-saving, and life sustaining not later than 2 years after the regulations are finalized, taking into account patient access to medical devices and therapies.
Under our July 10, 2012, proposed rule, all class III devices and all devices licensed under the Public Health Service Act (PHS Act) (42 U.S.C. 262) would be required to bear a UDI within 1 year of the date we publish a final rule; thus, this effective date does not need to be changed. Pursuant to amended section 519(f) of the FD&C Act, we are now proposing to require all other implantable, life-supporting, and life-sustaining devices (i.e., those that are not already subject to the 1-year effective date) to bear a UDI within 2 years following the publication of a final rule. (See proposed § 801.20(b)(2) as amended by this document.) Under our July 10, 2012, proposed rule, when a device is required to be labeled with a UDI, proposed § 830.300 would require the labeler of that device to submit information concerning the device to the GUDID. Consequently, the labelers of all implantable, life-supporting, and life-sustaining devices will be required to submit data to the GUDID within 2 years of the date we publish a final rule; see proposed § 801.20(b)(1) and (b)(2) as amended by this document.
Proposed § 801.50 would require direct marking of the UDI on the device itself for implantable devices, devices intended to be used more than once and that are intended to be sterilized before each use, and stand-alone software. We are now amending the proposed rule so that any such devices that fall into the categories specified by revised section 519(f) of the FD&C Act—devices that are implantable, life supporting, or life sustaining—would have to comply with § 801.50, establishing a system of unique device identification 2 years after publication of a final rule. FDA believes that the only devices subject to direct marking that fit within the device categories expressly referred to in revised section 519(f) of the FD&C Act are implantable devices and is assuming only implantable devices will be affected by the revised implementation date for the direct marking requirement. We welcome comments on whether any devices subject to the direct marking requirement under proposed § 801.50 other than implantable devices fit within the device categories in amended section 519(f) of the FD&C Act.
We are updating Table 7—Effective Dates of UDI Regulatory Requirements, of the July 10, 2012, proposed rule to reflect the revisions provided by this document; we have also corrected two citations within the table (citations to § 830.320 should have cited § 830.300). Updated table 7 appears in this document in section VI. Updated Proposed Effective Dates.
Table 8—Effects of the Amendments to the July 10, 2012, Proposed RuleCategory of deviceEffect of amendments to proposed ruleClass III implantable, life-supporting, and life-sustaining devices, and implantable, life-supporting, and life-sustaining devices licensed under the PHS ActNo effect with respect to proposed requirement for device to bear UDI on the label and device package or proposed requirements for submission of data to the GUDID. Implantable devices would have to bear a UDI as a permanent marking on the device itself 1 year earlier than first proposed.Class II implantable, life-supporting, and life-sustaining devicesWould have to bear a UDI on the label and device package and submit data to the GUDID 1 year earlier than first proposed. Implantable devices would have to bear a UDI as a permanent marking on the device itself 3 years earlier than first proposed.Class I implantable, life-supporting, and life-sustaining devices, and implantable, life-supporting, and life-sustaining devices that have not been classified into class I, II, or IIIWould have to bear a UDI on the label and device package and submit data to the GUDID 3 years earlier than first proposed. Implantable devices would have to bear a UDI as a permanent marking on the device itself 5 years earlier than first proposed.
Section 510(j) of the FD&C Act requires listing information to be accompanied by, at minimum, the label, package insert, and a representative sampling of any other labeling for the device (see section 510(j)(1)(B)(ii)). For certain categories of devices, all labeling must be submitted (see section 510(j)(1)(A) and (j)(1)(B)(i) of the FD&C Act). We expect most of the information that would be required to be submitted to the GUDID (see proposed § 830.310), is information that appears on the device label or in the package insert, and is included in the information that is required to be submitted to FDA by section 510(j) of the FD&C Act.
The provision of the proposed rule that would require that postmarket surveillance plans submitted to FDA include the device identifier of the devices involved is issued under sections 522 (21 U.S.C. 360 l), and 701(a) of the FD&C Act.
Our July 10, 2012, document summarizes the analysis of impacts of the proposed rule. The full analysis of impacts and findings that are presented in Preliminary Regulatory Impact Analysis (RIA) of the proposed rule remain unchanged (Ref. 10 of the July 10, 2012, proposed rule). However, we are amending our summary of costs to include the FDASIA requirement to incorporate the revised implementation date of 2 years for devices that are implantable, life-supporting, and life-sustaining. The July 10, 2012, RIA and the Addendum to the RIA (new Ref. 13) are available at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/ucm309815.htm.
Updated Table 3—Summary of the Estimated Regulatory Costs of the Proposed Rule[2010 dollars] 1 2Affected sectorsTotal present value of cost over 10 years ($ million)Total annualized costs over 10 years ($ million)3 Percent7 Percent3 Percent7 PercentDomestic Labelers$608.3$540.2$69.2$71.9.Issuing Agencies$1.0$0.9$0.1$0.1.FDA$16.1$13.7$1.8$1.8.ImportsNot quantifiedNot quantifiedNot quantifiedNot quantified.Total Domestic Cost of the Proposed Rule$625.4$554.8$71.1$73.8.1 Present value and annualized costs calculated at the beginning of the period.2 Domestic costs for labelers are revised to reflect FDASIA requirement that labelers of affected devices comply in year 2. However, FDA's revised estimate assumes that all class II devices would comply in year 2.
In accordance with section 3507(d) of the PRA (44 U.S.C. 3501 et seq.), the information collection or recordkeeping requirements included in this proposed rule have been submitted for approval to OMB. A copy of the supporting statement for this information collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain (OMB Number 0910-0720) and is posted to the docket at http://www.regulations.gov, in docket FDA-2011-N-0090 (Ref. 11 of the proposed rule).
FDA updates Table 7—Effective Dates of UDI Regulatory Requirements, in our July 10, 2012, proposed rule as follows. Updated Table 7—Effective Dates of UDI Regulatory RequirementsEffective dateRequirementImmediately upon publication of a final ruleRequests for an exception or alternative to UDI labeling requirements may be submitted pursuant to § 801.35. §§ 830.100-830.130 (subpart C of part 830, concerning accreditation of issuing Agencies) and § 830.10 (incorporation by reference of certain standards) go into effect. This will allow applications for accreditation as an issuing Agency to be submitted to FDA immediately.One year after publication of a final ruleDates on medical device labels must be formatted as required by § 801.18. The label and package of class III medical devices and devices licensed under the PHS Act must bear a UDI. § 801.20(b)(1). Data for class III devices and devices licensed under the PHS Act that are required to be labeled with a UDI must be submitted to the GUDID data base. § 830.300.Two years after publication of a final ruleThe label and package of implantable, life-supporting, and life-sustaining devices that are not class III devices or licensed under the PHS Act must bear a UDI. § 801.20(b)(2). Data for implantable, life-supporting, and life-sustaining devices that are not class III devices or licensed under the PHS Act and that are required to be labeled with a UDI, must be submitted to the GUDID data base. § 830.300. All implantable devices required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself. § 801.50.Three years after publication of a final ruleClass 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 (1) a device intended to be used more than once and intended to be sterilized before each use, or (2) stand-alone software regulated as a medical device. § 801.50. The label and package of class II medical devices must bear a UDI. § 801.20(b)(3). Data for class II devices that are required to be labeled with a UDI, must be submitted to the GUDID data base. § 830.300.Five years after publication of a final ruleClass II devices required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is (1) a device intended to be used more than once and intended to be sterilized before each use, or (2) stand-alone software regulated as a medical device. § 801.50. The label and package 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(b)(4), (5). 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 data base. § 830.300.Seven years after publication of a final ruleClass I devices and devices that have not been classified into class I, class II, or class III required to be labeled with a UDI must a bear UDI as a permanent marking on the device itself if the device is (1) a device intended to be used more than once and intended to be sterilized before each use, or (2) stand-alone software regulated as a medical device. § 801.50.90 days after publication of a final ruleAll other provisions go into effect, although some will have no practical effect until other provisions listed in this table go into effect.
Therefore, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq., as amended) and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR part 801, as proposed to be amended in the Federal Register of July 10, 2012 (77 FR 40736), be further amended as follows:
2. Revise § 801.20(b) to read as follows:
§ 801.20 Label to bear a unique device identifier (UDI).
(b) Effective dates. The requirements of paragraph (a) of this section become effective:
(1) If the device is a class III medical device or is a device licensed under section 351 of the Public Health Service Act, as amended, 5 U.S.C. 262, [A DATE WILL BE ADDED THAT IS 1 YEAR AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE Federal Register];
(2) If the device is an implantable, life-supporting, or life-sustaining device, and is not a class III device or a device licensed under section 351 of the Public Health Service Act, as amended, 5 U.S.C. 262, [A DATE WILL BE ADDED THAT IS 2 YEARS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE Federal Register];
(3) If the device is a class II medical device not covered by paragraph (2), [A DATE WILL BE ADDED THAT IS 3 YEARS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE Federal Register];
(4) If the device is a class I medical device not covered by paragraph (2), [A DATE WILL BE ADDED THAT IS 5 YEARS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE Federal Register];
(5) If the device is not classified into class I, II, or III, [A DATE WILL BE ADDED THAT IS 5 YEARS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE Federal Register].
3. Revise § 801.50(d) to read as follows:
§ 801.50 Devices that must be directly marked with a unique device identifier.
(d) Effective dates. The requirements of this section apply to a device that is an implantable, life-supporting, or life-sustaining device [A DATE WILL BE ADDED THAT IS 2 YEARS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE Federal Register], and to any other device 2 years after the date that applies to the device under § 801.20(b).
[FR Doc. 2012-28015 Filed 11-16-12; 8:45 am]