Regulatory Open Forum

For a conductive gel classified as a Class II medical device in the US, which is subject to UDI requirements, I have a question. The product packaging currently includes both an expiration date and batch number, and these are also printed as part of the UDI-PI. Is it necessary to duplicate the printing of the expiration date and batch number, or can we omit this additional printing since they are already included as part of UDI-PI?

Is there a guidance document I can refer in regards to this requirement?

Additional question - what is the date format (YYMMDD or YYYY-MM-DD) should be under UDI-DI?

For a conductive gel classified as a Class II medical device in the US, which is subject to UDI requirements, I have a question. The product packaging currently includes both an expiration date and batch number, and these are also printed as part of the UDI-PI. Is it necessary to duplicate the printing of the expiration date and batch number, or can we omit this additional printing since they are already included as part of UDI-PI?

Is there a guidance document I can refer in regards to this requirement?

Additional question - what is the date format (YYMMDD or YYYY-MM-DD) should be under UDI-DI?

For a conductive gel classified as a Class II medical device in the US, which is subject to UDI requirements, I have a question. The product packaging currently includes both an expiration date and batch number, and these are also printed as part of the UDI-PI. Is it necessary to duplicate the printing of the expiration date and batch number, or can we omit this additional printing since they are already included as part of UDI-PI?

Is there a guidance document I can refer in regards to this requirement?

For a conductive gel classified as a Class II medical device in the US, which is subject to UDI requirements, I have a question. The product packaging currently includes both an expiration date and batch number, and these are also printed as part of the UDI-PI. Is it necessary to duplicate the printing of the expiration date and batch number, or can we omit this additional printing since they are already included as part of UDI-PI?

Is there a guidance document I can refer in regards to this requirement?

Hi Anon,

as far as I can see, the information in the UDI-PI cannot replace the information on the label because it is drawn from it (see FDA's FAQ on UDI, A.3).

With respect to the date format: I think the date format within the HRI portion of the UDI (if that is what you mean with "under UDI-DI") follows the rules set by the issuing agency.

Best regards, Christoph

For a conductive gel classified as a Class II medical device in the US, which is subject to UDI requirements, I have a question. The product packaging currently includes both an expiration date and batch number, and these are also printed as part of the UDI-PI. Is it necessary to duplicate the printing of the expiration date and batch number, or can we omit this additional printing since they are already included as part of UDI-PI?

Is there a guidance document I can refer in regards to this requirement?

Apologies, I mean the HRI date format under UDI-PI. Should it be YYYY-MM-DD as per US regulation?

Hi Anon,

as far as I can see, the information in the UDI-PI cannot replace the information on the label because it is drawn from it (see FDA's FAQ on UDI, A.3).

With respect to the date format: I think the date format within the HRI portion of the UDI (if that is what you mean with "under UDI-DI") follows the rules set by the issuing agency.

Best regards, Christoph

For a conductive gel classified as a Class II medical device in the US, which is subject to UDI requirements, I have a question. The product packaging currently includes both an expiration date and batch number, and these are also printed as part of the UDI-PI. Is it necessary to duplicate the printing of the expiration date and batch number, or can we omit this additional printing since they are already included as part of UDI-PI?

Is there a guidance document I can refer in regards to this requirement?

Apologies, I mean the HRI date format under UDI-PI. Should it be YYYY-MM-DD as per US regulation?

Hi Anon,

as far as I can see, the information in the UDI-PI cannot replace the information on the label because it is drawn from it (see FDA's FAQ on UDI, A.3).

With respect to the date format: I think the date format within the HRI portion of the UDI (if that is what you mean with "under UDI-DI") follows the rules set by the issuing agency.

Best regards, Christoph

For a conductive gel classified as a Class II medical device in the US, which is subject to UDI requirements, I have a question. The product packaging currently includes both an expiration date and batch number, and these are also printed as part of the UDI-PI. Is it necessary to duplicate the printing of the expiration date and batch number, or can we omit this additional printing since they are already included as part of UDI-PI?

Is there a guidance document I can refer in regards to this requirement?