Final FDA Rule Out for Medical Device Unique Identifiers
Six years after authorizing legislation was enacted, the Food and Drug Administration has issued a final rule to establish a unique device identifier for medical devices.
Six years after authorizing legislation was enacted, the Food and Drug Administration has issued a final rule to establish a unique device identifier for medical devices.
Compliance dates for various provisions in the rule, available here and effective 90 days after formal publication on Sept. 24, stretch out between 2014 and 2020. Congress authorized the UDI in 2007 to better enable users to track medical devices and enable the FDA to identify safety or effectiveness concerns quicker, and to better target recalls.
Also now available is draft guidance for public comment on the Global Unique Device Identification Database that FDA will use to house UDI information. “Labelers will be responsible for submitting information to the GUDID as part of their UDI requirements,” according to the guidance document. The guidance describes how labelers will obtain access to the GUDID, how to submit device identifier records to the database, and how stakeholders can search and retrieve device information.
In general, the final rule requires the label of medical devices to include a UDI, with some exceptions or alternative placement depending on characteristics of a device. “The system established by this rule requires the label and device package of each medical device to include a UDI and requires that each UDI be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology,” according to the final rule. “The UDI will be required to be directly marked on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.”
Compliance dates for the final UDI rule include:
* Sept. 24, 2014: Labels and packages of class III medical devices and devices licensed under the Public Health Service Act must bear a UDI. A one-year extension of the compliance date may be requested no later than 270 days after the rule is published. Class III standalone software also must have an UDI.
* Sept. 24, 2015: Labels and packages of implantable, life-supporting, and life-sustaining devices must bear a UDI. Life-supporting or life-sustaining devices also must have the UDI as a permanent marking on the device if intended to be used more than once and reprocessed before each use. Standalone software that is a life-supporting or life-sustaining device also must have a UDI. Data for implantable, life-supporting and life-sustaining devices requiring a UDI must be submitted to the GUDID database.
* Sept. 24, 2016: Class III devices required to be labeled must bear the UDI as a permanent marking on the device if intended to be used more than once and reprocessed before each use. Labels and packages of class II devices must bear a UDI, along with standalone class II software. Data for class II device must be submitted to the GUDID.
* Sept. 24, 2018: Class II devices required to be labeled must bear the permanent marking of a UDI on the device itself if used more than once and reprocessed before each use. Labels and packages of class I medical devices and devices not classified into class I, class II or class III must bear a UDI. Data for class I and unclassified devices required to have a UDI must be submitted to the GUDID database. Class I standalone software must have a UDI.
* Sept. 24, 2020: Class I medical devices and devices not classified into one of the three classes must bear a UDI as a permanent marking if used more than once and reprocessed before each use.
Provider alliance Premier Inc. issued the following statement on release of the rule:
“With today’s announcement, those who have been advocating for patient safety have reasons to cheer. With this rule, we are one step closer to a UDI system that will enhance adverse event reporting, a safety gap that the Institute of Medicine said made it impossible to draw conclusions about the safety of medical devices. Moreover, UDI will dramatically improve the recall process. Research also shows that UDI can save as much as $16 billion annually by automating manual processes and improving efficiencies.
“Unfortunately, the rule proposes an excessively lengthy implementation timeline. Since we have already been waiting six years for UDI, it’s unfortunate that patients will have to wait until 2020 to have a fully functional device tracking system, particularly since such systems are so pervasive in the retail setting. It is our goal to work with our member hospitals to implement the provisions of this rule as quickly as possible to ensure that patients will have confidence that the devices implanted in their bodies are safe and effective.“
Compliance dates for various provisions in the rule, available here and effective 90 days after formal publication on Sept. 24, stretch out between 2014 and 2020. Congress authorized the UDI in 2007 to better enable users to track medical devices and enable the FDA to identify safety or effectiveness concerns quicker, and to better target recalls.
Also now available is draft guidance for public comment on the Global Unique Device Identification Database that FDA will use to house UDI information. “Labelers will be responsible for submitting information to the GUDID as part of their UDI requirements,” according to the guidance document. The guidance describes how labelers will obtain access to the GUDID, how to submit device identifier records to the database, and how stakeholders can search and retrieve device information.
In general, the final rule requires the label of medical devices to include a UDI, with some exceptions or alternative placement depending on characteristics of a device. “The system established by this rule requires the label and device package of each medical device to include a UDI and requires that each UDI be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology,” according to the final rule. “The UDI will be required to be directly marked on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.”
Compliance dates for the final UDI rule include:
* Sept. 24, 2014: Labels and packages of class III medical devices and devices licensed under the Public Health Service Act must bear a UDI. A one-year extension of the compliance date may be requested no later than 270 days after the rule is published. Class III standalone software also must have an UDI.
* Sept. 24, 2015: Labels and packages of implantable, life-supporting, and life-sustaining devices must bear a UDI. Life-supporting or life-sustaining devices also must have the UDI as a permanent marking on the device if intended to be used more than once and reprocessed before each use. Standalone software that is a life-supporting or life-sustaining device also must have a UDI. Data for implantable, life-supporting and life-sustaining devices requiring a UDI must be submitted to the GUDID database.
* Sept. 24, 2016: Class III devices required to be labeled must bear the UDI as a permanent marking on the device if intended to be used more than once and reprocessed before each use. Labels and packages of class II devices must bear a UDI, along with standalone class II software. Data for class II device must be submitted to the GUDID.
* Sept. 24, 2018: Class II devices required to be labeled must bear the permanent marking of a UDI on the device itself if used more than once and reprocessed before each use. Labels and packages of class I medical devices and devices not classified into class I, class II or class III must bear a UDI. Data for class I and unclassified devices required to have a UDI must be submitted to the GUDID database. Class I standalone software must have a UDI.
* Sept. 24, 2020: Class I medical devices and devices not classified into one of the three classes must bear a UDI as a permanent marking if used more than once and reprocessed before each use.
Provider alliance Premier Inc. issued the following statement on release of the rule:
“With today’s announcement, those who have been advocating for patient safety have reasons to cheer. With this rule, we are one step closer to a UDI system that will enhance adverse event reporting, a safety gap that the Institute of Medicine said made it impossible to draw conclusions about the safety of medical devices. Moreover, UDI will dramatically improve the recall process. Research also shows that UDI can save as much as $16 billion annually by automating manual processes and improving efficiencies.
“Unfortunately, the rule proposes an excessively lengthy implementation timeline. Since we have already been waiting six years for UDI, it’s unfortunate that patients will have to wait until 2020 to have a fully functional device tracking system, particularly since such systems are so pervasive in the retail setting. It is our goal to work with our member hospitals to implement the provisions of this rule as quickly as possible to ensure that patients will have confidence that the devices implanted in their bodies are safe and effective.“
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