Regulatory Open Forum

We make orthopedic implants. We do not yet have capability to print AIDC for direct marking. We are using human readable only. As I read the GS1 for direct marking, the HRI is described specifically in the context of AIDC and includes the parenthetical identifiers for the elements of the UDI.  As the GS1 general specifications notes "Note: At present, HRI rules are applicable to barcodes as rules for EPC/RFID tags are under development" in section 4.15, Human readable interpretation rules. As the HRI rules apply to barcodes, we are not including the parenthetical identifiers in our direct marking as there is no barcode currently.

Does anyone have any clarity on the requirement for the identifiers when there is no barcode used in conjunction with the human readable information in direct marking?
Thanks,
Jackie

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA
------------------------------

Hi Jackie

As far as I know there is no requirement for direct marking of implantable devices in the US​, since it wouldn't be very practical for identifying them after they're implanted. For things that are being directly marked, the July guidance on Form and Content of the Unique Device Identifier says FDA considers the data delimiters to be important, since they help in recognizing the production identifier(s). For example, how would you know if it's a date of manufacture or a use-by date or an 8-character batch identifier?

------------------------------
Anne LeBlanc
United States
------------------------------

Original Message:
Sent: 23-Jul-2021 15:01
From: Jackie Jaskula
Subject: Direct marking HRI (UDI)

We make orthopedic implants. We do not yet have capability to print AIDC for direct marking. We are using human readable only. As I read the GS1 for direct marking, the HRI is described specifically in the context of AIDC and includes the parenthetical identifiers for the elements of the UDI.  As the GS1 general specifications notes "Note: At present, HRI rules are applicable to barcodes as rules for EPC/RFID tags are under development" in section 4.15, Human readable interpretation rules. As the HRI rules apply to barcodes, we are not including the parenthetical identifiers in our direct marking as there is no barcode currently.

Does anyone have any clarity on the requirement for the identifiers when there is no barcode used in conjunction with the human readable information in direct marking?
Thanks,
Jackie

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA
------------------------------

Hello Jackie,

If you go back to reading the comments on the original draft regulation for Unique Device Identification (UDI) in the United States there were many comments which as Anne stated, the implant marking would not necessarily make sense after implantation.  Also the US FDA did clarify implants being separated from the packaging do not require direct marking.  In addition, there is the statement that if not practical or would interfere with the safety and effectiveness of device would also not be required.  This is also in the EU or other country regulations which there is still some interpretations being made at the moment.  There is some wording in the regulation which many infer direct marking only applies to devices which are reusable or processed between patients (Annex VI, Part C) and implants are single-use though separated from packaging would not apply UDI Carrier (AIDC) or even HRI directly on the device.  Personally, direct marking would apply where it is feasible, does not interfere with safety and performance, or not used when not technologically feasible.  Plus the EU MDR has the Implant Card from Article 18 which contains the UDI requirement.  From what I see in the industry depending on the implant these are generally not expected to have direct marking, AIDC or HRI, there may be some like active implantable devices which would make sense and even needed as part of traceability.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 23-Jul-2021 19:09
From: Anne LeBlanc
Subject: Direct marking HRI (UDI)

Hi Jackie

As far as I know there is no requirement for direct marking of implantable devices in the US​, since it wouldn't be very practical for identifying them after they're implanted. For things that are being directly marked, the July guidance on Form and Content of the Unique Device Identifier says FDA considers the data delimiters to be important, since they help in recognizing the production identifier(s). For example, how would you know if it's a date of manufacture or a use-by date or an 8-character batch identifier?

------------------------------
Anne LeBlanc
United States

Original Message:
Sent: 23-Jul-2021 15:01
From: Jackie Jaskula
Subject: Direct marking HRI (UDI)

We make orthopedic implants. We do not yet have capability to print AIDC for direct marking. We are using human readable only. As I read the GS1 for direct marking, the HRI is described specifically in the context of AIDC and includes the parenthetical identifiers for the elements of the UDI.  As the GS1 general specifications notes "Note: At present, HRI rules are applicable to barcodes as rules for EPC/RFID tags are under development" in section 4.15, Human readable interpretation rules. As the HRI rules apply to barcodes, we are not including the parenthetical identifiers in our direct marking as there is no barcode currently.

Does anyone have any clarity on the requirement for the identifiers when there is no barcode used in conjunction with the human readable information in direct marking?
Thanks,
Jackie

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA
------------------------------

@Richard Vincins and @Anne LeBlanc
Thanks for responding.  I confused things regarding our device types. We make implants but we also make instruments that require direct marking. When direct marking on devices that require it, would the parenthetical identifiers be required when human readable UDI is applied without the barcode.
​​

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA
------------------------------

Original Message:
Sent: 26-Jul-2021 07:46
From: Richard Vincins
Subject: Direct marking HRI (UDI)

Hello Jackie,

If you go back to reading the comments on the original draft regulation for Unique Device Identification (UDI) in the United States there were many comments which as Anne stated, the implant marking would not necessarily make sense after implantation.  Also the US FDA did clarify implants being separated from the packaging do not require direct marking.  In addition, there is the statement that if not practical or would interfere with the safety and effectiveness of device would also not be required.  This is also in the EU or other country regulations which there is still some interpretations being made at the moment.  There is some wording in the regulation which many infer direct marking only applies to devices which are reusable or processed between patients (Annex VI, Part C) and implants are single-use though separated from packaging would not apply UDI Carrier (AIDC) or even HRI directly on the device.  Personally, direct marking would apply where it is feasible, does not interfere with safety and performance, or not used when not technologically feasible.  Plus the EU MDR has the Implant Card from Article 18 which contains the UDI requirement.  From what I see in the industry depending on the implant these are generally not expected to have direct marking, AIDC or HRI, there may be some like active implantable devices which would make sense and even needed as part of traceability.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 23-Jul-2021 19:09
From: Anne LeBlanc
Subject: Direct marking HRI (UDI)

Hi Jackie

As far as I know there is no requirement for direct marking of implantable devices in the US​, since it wouldn't be very practical for identifying them after they're implanted. For things that are being directly marked, the July guidance on Form and Content of the Unique Device Identifier says FDA considers the data delimiters to be important, since they help in recognizing the production identifier(s). For example, how would you know if it's a date of manufacture or a use-by date or an 8-character batch identifier?

------------------------------
Anne LeBlanc
United States

Original Message:
Sent: 23-Jul-2021 15:01
From: Jackie Jaskula
Subject: Direct marking HRI (UDI)

We make orthopedic implants. We do not yet have capability to print AIDC for direct marking. We are using human readable only. As I read the GS1 for direct marking, the HRI is described specifically in the context of AIDC and includes the parenthetical identifiers for the elements of the UDI.  As the GS1 general specifications notes "Note: At present, HRI rules are applicable to barcodes as rules for EPC/RFID tags are under development" in section 4.15, Human readable interpretation rules. As the HRI rules apply to barcodes, we are not including the parenthetical identifiers in our direct marking as there is no barcode currently.

Does anyone have any clarity on the requirement for the identifiers when there is no barcode used in conjunction with the human readable information in direct marking?
Thanks,
Jackie

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA
------------------------------

Hello Jackie,

If this is for the surgical instruments which are reusable/processed between use the UDI Carrier (AIDC and HRI) does need to be on the device.  There are some exceptions such as the FDA says if interfere with safety or efficacy or not technically feasible.  Same goes with the EU regulation if you read Annex VI, Part C, section 4.7 and 4.10 has same kind of wording.  If you do not include both on the surgical instrument, you "self exempt" the device from the requirements, make sure to document this justification and rationale in the Design History File, Device Master File, Medical Device File, and/or Technical Documentation.  Unfortunately the regulations do not really provide much distinction of reusable devices/multi-use devices like a surgical instrument compared to a portable infusion pump.  Whichever approach you take, just make sure to clearly document your reason and justification citing safety or feasibility.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 26-Jul-2021 08:44
From: Jackie Jaskula
Subject: Direct marking HRI (UDI)

@Richard Vincins and @Anne LeBlanc
Thanks for responding.  I confused things regarding our device types. We make implants but we also make instruments that require direct marking. When direct marking on devices that require it, would the parenthetical identifiers be required when human readable UDI is applied without the barcode.

Thanks,

Jackie

​​

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA

Original Message:
Sent: 26-Jul-2021 07:46
From: Richard Vincins
Subject: Direct marking HRI (UDI)

Hello Jackie,

If you go back to reading the comments on the original draft regulation for Unique Device Identification (UDI) in the United States there were many comments which as Anne stated, the implant marking would not necessarily make sense after implantation.  Also the US FDA did clarify implants being separated from the packaging do not require direct marking.  In addition, there is the statement that if not practical or would interfere with the safety and effectiveness of device would also not be required.  This is also in the EU or other country regulations which there is still some interpretations being made at the moment.  There is some wording in the regulation which many infer direct marking only applies to devices which are reusable or processed between patients (Annex VI, Part C) and implants are single-use though separated from packaging would not apply UDI Carrier (AIDC) or even HRI directly on the device.  Personally, direct marking would apply where it is feasible, does not interfere with safety and performance, or not used when not technologically feasible.  Plus the EU MDR has the Implant Card from Article 18 which contains the UDI requirement.  From what I see in the industry depending on the implant these are generally not expected to have direct marking, AIDC or HRI, there may be some like active implantable devices which would make sense and even needed as part of traceability.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 23-Jul-2021 19:09
From: Anne LeBlanc
Subject: Direct marking HRI (UDI)

Hi Jackie

As far as I know there is no requirement for direct marking of implantable devices in the US​, since it wouldn't be very practical for identifying them after they're implanted. For things that are being directly marked, the July guidance on Form and Content of the Unique Device Identifier says FDA considers the data delimiters to be important, since they help in recognizing the production identifier(s). For example, how would you know if it's a date of manufacture or a use-by date or an 8-character batch identifier?

------------------------------
Anne LeBlanc
United States

Original Message:
Sent: 23-Jul-2021 15:01
From: Jackie Jaskula
Subject: Direct marking HRI (UDI)

We make orthopedic implants. We do not yet have capability to print AIDC for direct marking. We are using human readable only. As I read the GS1 for direct marking, the HRI is described specifically in the context of AIDC and includes the parenthetical identifiers for the elements of the UDI.  As the GS1 general specifications notes "Note: At present, HRI rules are applicable to barcodes as rules for EPC/RFID tags are under development" in section 4.15, Human readable interpretation rules. As the HRI rules apply to barcodes, we are not including the parenthetical identifiers in our direct marking as there is no barcode currently.

Does anyone have any clarity on the requirement for the identifiers when there is no barcode used in conjunction with the human readable information in direct marking?
Thanks,
Jackie

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA
------------------------------

Thanks, Richard. Initiating the quality plan to document the decisions is in process. Good to have validation of that activity!
Jackie

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA
------------------------------

Original Message:
Sent: 27-Jul-2021 05:02
From: Richard Vincins
Subject: Direct marking HRI (UDI)

Hello Jackie,

If this is for the surgical instruments which are reusable/processed between use the UDI Carrier (AIDC and HRI) does need to be on the device.  There are some exceptions such as the FDA says if interfere with safety or efficacy or not technically feasible.  Same goes with the EU regulation if you read Annex VI, Part C, section 4.7 and 4.10 has same kind of wording.  If you do not include both on the surgical instrument, you "self exempt" the device from the requirements, make sure to document this justification and rationale in the Design History File, Device Master File, Medical Device File, and/or Technical Documentation.  Unfortunately the regulations do not really provide much distinction of reusable devices/multi-use devices like a surgical instrument compared to a portable infusion pump.  Whichever approach you take, just make sure to clearly document your reason and justification citing safety or feasibility.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 26-Jul-2021 08:44
From: Jackie Jaskula
Subject: Direct marking HRI (UDI)

@Richard Vincins and @Anne LeBlanc
Thanks for responding.  I confused things regarding our device types. We make implants but we also make instruments that require direct marking. When direct marking on devices that require it, would the parenthetical identifiers be required when human readable UDI is applied without the barcode.

Thanks,

Jackie

​​

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA

Original Message:
Sent: 26-Jul-2021 07:46
From: Richard Vincins
Subject: Direct marking HRI (UDI)

Hello Jackie,

If you go back to reading the comments on the original draft regulation for Unique Device Identification (UDI) in the United States there were many comments which as Anne stated, the implant marking would not necessarily make sense after implantation.  Also the US FDA did clarify implants being separated from the packaging do not require direct marking.  In addition, there is the statement that if not practical or would interfere with the safety and effectiveness of device would also not be required.  This is also in the EU or other country regulations which there is still some interpretations being made at the moment.  There is some wording in the regulation which many infer direct marking only applies to devices which are reusable or processed between patients (Annex VI, Part C) and implants are single-use though separated from packaging would not apply UDI Carrier (AIDC) or even HRI directly on the device.  Personally, direct marking would apply where it is feasible, does not interfere with safety and performance, or not used when not technologically feasible.  Plus the EU MDR has the Implant Card from Article 18 which contains the UDI requirement.  From what I see in the industry depending on the implant these are generally not expected to have direct marking, AIDC or HRI, there may be some like active implantable devices which would make sense and even needed as part of traceability.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 23-Jul-2021 19:09
From: Anne LeBlanc
Subject: Direct marking HRI (UDI)

Hi Jackie

As far as I know there is no requirement for direct marking of implantable devices in the US​, since it wouldn't be very practical for identifying them after they're implanted. For things that are being directly marked, the July guidance on Form and Content of the Unique Device Identifier says FDA considers the data delimiters to be important, since they help in recognizing the production identifier(s). For example, how would you know if it's a date of manufacture or a use-by date or an 8-character batch identifier?

------------------------------
Anne LeBlanc
United States

Original Message:
Sent: 23-Jul-2021 15:01
From: Jackie Jaskula
Subject: Direct marking HRI (UDI)

We make orthopedic implants. We do not yet have capability to print AIDC for direct marking. We are using human readable only. As I read the GS1 for direct marking, the HRI is described specifically in the context of AIDC and includes the parenthetical identifiers for the elements of the UDI.  As the GS1 general specifications notes "Note: At present, HRI rules are applicable to barcodes as rules for EPC/RFID tags are under development" in section 4.15, Human readable interpretation rules. As the HRI rules apply to barcodes, we are not including the parenthetical identifiers in our direct marking as there is no barcode currently.

Does anyone have any clarity on the requirement for the identifiers when there is no barcode used in conjunction with the human readable information in direct marking?
Thanks,
Jackie

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA
------------------------------

Hello Jackie,

I believe FDA's UDI Rule does allow for direct marking to be provided through either or both of the following: easily readable plain-text; AIDC or equivalent technology.  Section 801.45(b)(1) mentions that the UDI provided through direct marking may be the same as the UDI on the label, or a different UDI. 

In all cases, the term "UDI" is used, which implies that the direct marking should contain all parts of a UDI (i.e. device identifier and production identifier(s)).  The user would need to be able to distinguish the various parts of the UDI, in order for it to be useful for traceability purposes.  Is there another way of identifying the portions of the human readable UDI, if parenthetical identifiers are not being used?  

Best Regards,



------------------------------
Camille Thorpe, RAC
Toronto, ON
Canada
------------------------------

Original Message:
Sent: 26-Jul-2021 08:44
From: Jackie Jaskula
Subject: Direct marking HRI (UDI)

@Richard Vincins and @Anne LeBlanc
Thanks for responding.  I confused things regarding our device types. We make implants but we also make instruments that require direct marking. When direct marking on devices that require it, would the parenthetical identifiers be required when human readable UDI is applied without the barcode.

Thanks,

Jackie

​​

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA

Original Message:
Sent: 26-Jul-2021 07:46
From: Richard Vincins
Subject: Direct marking HRI (UDI)

Hello Jackie,

If you go back to reading the comments on the original draft regulation for Unique Device Identification (UDI) in the United States there were many comments which as Anne stated, the implant marking would not necessarily make sense after implantation.  Also the US FDA did clarify implants being separated from the packaging do not require direct marking.  In addition, there is the statement that if not practical or would interfere with the safety and effectiveness of device would also not be required.  This is also in the EU or other country regulations which there is still some interpretations being made at the moment.  There is some wording in the regulation which many infer direct marking only applies to devices which are reusable or processed between patients (Annex VI, Part C) and implants are single-use though separated from packaging would not apply UDI Carrier (AIDC) or even HRI directly on the device.  Personally, direct marking would apply where it is feasible, does not interfere with safety and performance, or not used when not technologically feasible.  Plus the EU MDR has the Implant Card from Article 18 which contains the UDI requirement.  From what I see in the industry depending on the implant these are generally not expected to have direct marking, AIDC or HRI, there may be some like active implantable devices which would make sense and even needed as part of traceability.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 23-Jul-2021 19:09
From: Anne LeBlanc
Subject: Direct marking HRI (UDI)

Hi Jackie

As far as I know there is no requirement for direct marking of implantable devices in the US​, since it wouldn't be very practical for identifying them after they're implanted. For things that are being directly marked, the July guidance on Form and Content of the Unique Device Identifier says FDA considers the data delimiters to be important, since they help in recognizing the production identifier(s). For example, how would you know if it's a date of manufacture or a use-by date or an 8-character batch identifier?

------------------------------
Anne LeBlanc
United States

Original Message:
Sent: 23-Jul-2021 15:01
From: Jackie Jaskula
Subject: Direct marking HRI (UDI)

We make orthopedic implants. We do not yet have capability to print AIDC for direct marking. We are using human readable only. As I read the GS1 for direct marking, the HRI is described specifically in the context of AIDC and includes the parenthetical identifiers for the elements of the UDI.  As the GS1 general specifications notes "Note: At present, HRI rules are applicable to barcodes as rules for EPC/RFID tags are under development" in section 4.15, Human readable interpretation rules. As the HRI rules apply to barcodes, we are not including the parenthetical identifiers in our direct marking as there is no barcode currently.

Does anyone have any clarity on the requirement for the identifiers when there is no barcode used in conjunction with the human readable information in direct marking?
Thanks,
Jackie

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA
------------------------------

Camille,
Thanks for that thoughtful response. I'll go back and look at our direct marking format with consideration for identifying the HRI portions from a user perspective.
Jackie

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA
------------------------------

Original Message:
Sent: 27-Jul-2021 19:57
From: Camille Thorpe
Subject: Direct marking HRI (UDI)

Hello Jackie,

I believe FDA's UDI Rule does allow for direct marking to be provided through either or both of the following: easily readable plain-text; AIDC or equivalent technology.  Section 801.45(b)(1) mentions that the UDI provided through direct marking may be the same as the UDI on the label, or a different UDI.

In all cases, the term "UDI" is used, which implies that the direct marking should contain all parts of a UDI (i.e. device identifier and production identifier(s)).  The user would need to be able to distinguish the various parts of the UDI, in order for it to be useful for traceability purposes.  Is there another way of identifying the portions of the human readable UDI, if parenthetical identifiers are not being used?

Best Regards,



------------------------------
Camille Thorpe, RAC
Toronto, ON
Canada

Original Message:
Sent: 26-Jul-2021 08:44
From: Jackie Jaskula
Subject: Direct marking HRI (UDI)

@Richard Vincins and @Anne LeBlanc
Thanks for responding.  I confused things regarding our device types. We make implants but we also make instruments that require direct marking. When direct marking on devices that require it, would the parenthetical identifiers be required when human readable UDI is applied without the barcode.

Thanks,

Jackie

​​

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA

Original Message:
Sent: 26-Jul-2021 07:46
From: Richard Vincins
Subject: Direct marking HRI (UDI)

Hello Jackie,

If you go back to reading the comments on the original draft regulation for Unique Device Identification (UDI) in the United States there were many comments which as Anne stated, the implant marking would not necessarily make sense after implantation.  Also the US FDA did clarify implants being separated from the packaging do not require direct marking.  In addition, there is the statement that if not practical or would interfere with the safety and effectiveness of device would also not be required.  This is also in the EU or other country regulations which there is still some interpretations being made at the moment.  There is some wording in the regulation which many infer direct marking only applies to devices which are reusable or processed between patients (Annex VI, Part C) and implants are single-use though separated from packaging would not apply UDI Carrier (AIDC) or even HRI directly on the device.  Personally, direct marking would apply where it is feasible, does not interfere with safety and performance, or not used when not technologically feasible.  Plus the EU MDR has the Implant Card from Article 18 which contains the UDI requirement.  From what I see in the industry depending on the implant these are generally not expected to have direct marking, AIDC or HRI, there may be some like active implantable devices which would make sense and even needed as part of traceability.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 23-Jul-2021 19:09
From: Anne LeBlanc
Subject: Direct marking HRI (UDI)

Hi Jackie

As far as I know there is no requirement for direct marking of implantable devices in the US​, since it wouldn't be very practical for identifying them after they're implanted. For things that are being directly marked, the July guidance on Form and Content of the Unique Device Identifier says FDA considers the data delimiters to be important, since they help in recognizing the production identifier(s). For example, how would you know if it's a date of manufacture or a use-by date or an 8-character batch identifier?

------------------------------
Anne LeBlanc
United States

Original Message:
Sent: 23-Jul-2021 15:01
From: Jackie Jaskula
Subject: Direct marking HRI (UDI)

We make orthopedic implants. We do not yet have capability to print AIDC for direct marking. We are using human readable only. As I read the GS1 for direct marking, the HRI is described specifically in the context of AIDC and includes the parenthetical identifiers for the elements of the UDI.  As the GS1 general specifications notes "Note: At present, HRI rules are applicable to barcodes as rules for EPC/RFID tags are under development" in section 4.15, Human readable interpretation rules. As the HRI rules apply to barcodes, we are not including the parenthetical identifiers in our direct marking as there is no barcode currently.

Does anyone have any clarity on the requirement for the identifiers when there is no barcode used in conjunction with the human readable information in direct marking?
Thanks,
Jackie

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA
------------------------------