SEMPERGRAMS
February 21, 2020
Private Label UDI Compliance
Just a friendly reminder, FDA enforcement of Unique Device Identification (UDI) labeling and data submission for Class 1 medical devices, including disposable surgical and examination gloves, will begin on September 24, 2020.
In order to be compliant, the labeler must 1) have barcodes on labeling, and 2) must submit required information to the FDA Global Unique Device Identifier Database (GUDID). The FDA defines a labeler as:
(1) Any person who causes a label to be applied to a device with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label; and
(2) Any person who causes the label of a device to be replaced or modified with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label, except that the addition of the name of, and contact information for, a person who distributes the device, without making any other changes to the label, is not a modification for the purposes of determining whether a person is a labeler.
If your customer is private labeling gloves, they
are the labeler. They are therefore responsible for their own labeling barcodes and must enter associated information in the FDA GUDID database. Sempermed cannot complete this for
them.
In order to be compliant, the labeler must 1) have barcodes on labeling, and 2) must submit required information to the FDA Global Unique Device Identifier Database (GUDID). The FDA defines a labeler as:
(1) Any person who causes a label to be applied to a device with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label; and
(2) Any person who causes the label of a device to be replaced or modified with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label, except that the addition of the name of, and contact information for, a person who distributes the device, without making any other changes to the label, is not a modification for the purposes of determining whether a person is a labeler.
If your customer is private labeling gloves, they
are the labeler. They are therefore responsible for their own labeling barcodes and must enter associated information in the FDA GUDID database. Sempermed cannot complete this for
them.
