/>iThe U.S. Food and Drug Administration (FDA) recently announced an amendment to its proposed rule to require most medical devices distributed in the United States to carry a unique device identifier (UDI). According to FDA, the amendment is required by the FDA Safety and Innovation Act (FDA SIA) signed into law in early July of this year.
Under the proposed rule, a UDI is a unique numeric or alphanumeric code that includes a device identifier and a production identifier. The device identifier is specific to a labeler (typically, the manufacturer) and device model. The production identifier includes the current production information for that specific device, such as the lot or batch number, the serial number and/or expiration date.
The proposed rule requires the label of medical devices and device packages to include a UDI, with certain exceptions for alternative placement of the UDI and for particular devices or device types. Each UDI would have to be provided in a plain-text version and in a form that uses bar code, RFID, or similar technology. The UDI would also be required to be directly marked on the device itself for certain categories of devices, such as implantable devices.
The proposed rule originally provided that any final rule would become effective in stages over a period of seven years. One year after publication of the final rule, the label and package for class III medical devices were to bear a UDI. Class II device labels followed two years later, and class I and unclassified labels followed two more years after class II. For devices that must be marked, the start date for class III devices is three years after publication of the final rule, with class II following two years later and class I and unclassified following two more years later.
The recent amendment to the proposed rule bears on the effective date for certain types of devices. As amended by FDA SIA, Section 519(f) of the Food, Drug & Cosmetic Act now requires that FDA “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.” Accordingly, FDA amended the proposed rule to bring the effective dates into compliance with FDA SIA. The amendment includes the following chart showing the effect of the amendment:
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Category of Device |
Effect of Amendments on Proposed Rule |
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Class III implantable, life-supporting, and life-sustaining devices, and implantable, life-supporting, and life-sustaining devices licensed under the PHS Act. |
No 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 devices |
Would 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 III |
Would 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. |
The amendment also includes the following helpful, albeit somewhat complicated, chart summarizing the effective dates of the proposed rule after the amendment:
|
Effective Date |
Requirement |
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Immediately upon publication of a final rule.
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Requests for an exception or alternative to UDI labeling requirements may be submitted pursuant to § 801.35. |
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§§ 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. |
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|
One year after publication of a final rule |
Dates on medical device labels must be formatted as required by § 801.18. |
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The label and package of class III medical devices and devices licensed under the PHS Act must bear a UDI. § 801.20(b)(1). |
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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. |
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Two years after publication of a final rule |
The 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. |
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|
All implantable devices required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself. § 801.50. |
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Three years after publication of a final rule |
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 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. |
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The label and package of class II medical devices must bear a UDI. § 801.20(b)(3). |
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Data for class II devices that are required to be labeled with a UDI, must be submitted to the GUDID data base. § 830.300. |
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Five years after publication of a final rule
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Class 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. |
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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). |
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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. |
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Seven years after publication of a final rule |
Class 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 rule |
All other provisions go into effect, although some will have no practical effect until other provisions listed in this table go into effect. |
The FDA announced the amendment after the close of the period for public comment on the proposed rule, and stated that it does not believe the amendment requires it to re-open the comment period.
The full text of the amendment can be found by clicking here.
