FDA Seeks UDI Amendment Comments
These amendments affect only implantable, life-supporting, or life sustaining devices. With the exception of the change to the proposed effective date for the direct marking requirement, these amendments do not affect class III devices or devices licensed under the PHS Act because such devices would have to bear a UDI within 1 year of finalization under the July 10, 2012, proposed rule.
|
Category of device |
Effect of amendments to proposed rule |
| 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 |
