Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

For a medical device with an expiration date, is it enough to indicate the expiration date in the product label, or should the manufacturing date be included as well?

REF , LOT, are included as well.

(for the US market)

Hello Anon,

There are no specific rules or requirements regarding inclusion of an expiration date and manufacturing date.  However, in most cases if there is an expiration date, a manufacturing date is not needed because the expiration date would be the pertinent information to convey.  Also, most of the time a manufacturing date would be stated for a product which does not have a shelf life or expiration date such as durable equipment.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 03-Aug-2023 15:16
From: Anonymous Member
Subject: Expiration date AND/OR Manufacturing date.

This message was posted by a user wishing to remain anonymous

For a medical device with an expiration date, is it enough to indicate the expiration date in the product label, or should the manufacturing date be included as well?

REF , LOT, are included as well.

(for the US market)

The correct answer will ultimately depend on the class and type of device.  In theory, United States statutes and regulations for medical device adulteration, misbranding, and design control could conceivably lead the designer to a need for both an expiration date and manufacturing date on the label. Same thing regarding REF and LOT.  For example, if your design inputs/outputs and/or risk controls derive the need for both an expiration date and manufacturing date on the label, then both would be required per the subject device's intrinsic safety and effectiveness needs. Other than these U.S. statutory and regulatory requirements, I know of no further U.S. statute or regulation directly demanding either an expiration date or manufacturing date on the label.  Same thing regarding REF and LOT with the exception of higher-risk devices subject to FDA's traceability and tracking regulations.

To help keep the thread on point, I'll forego delving into Europe's requirements since that jurisdiction is outside the scope of your question.  Yet I will mention one thing for practical intents and purposes: The EU MDR specifically requires either an expiration date or a manufacturing date on the label.  This represents a more prescriptive distinction compared to the U.S.'s generalized approach.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 06-Aug-2023 16:38
From: Richard Vincins
Subject: Expiration date AND/OR Manufacturing date.

Hello Anon,

There are no specific rules or requirements regarding inclusion of an expiration date and manufacturing date.  However, in most cases if there is an expiration date, a manufacturing date is not needed because the expiration date would be the pertinent information to convey.  Also, most of the time a manufacturing date would be stated for a product which does not have a shelf life or expiration date such as durable equipment.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 03-Aug-2023 15:16
From: Anonymous Member
Subject: Expiration date AND/OR Manufacturing date.

This message was posted by a user wishing to remain anonymous

For a medical device with an expiration date, is it enough to indicate the expiration date in the product label, or should the manufacturing date be included as well?

REF , LOT, are included as well.

(for the US market)

In the MDR, Annex VI, Section 3.5 says: If a lot number, serial number, software identification or expiry date appears on the label, it shall be part of the UDI-PI. If there is also a manufacturing date on the label, it does not need to be included in the UDI-PI. If there is only a manufacturing date on the label, this shall be used as the UDI-PI.

For UDI, the answer to your question would be that it would be sufficient to add the expiry date to the label and include in the UDI-PI. If REF and LOT are also on the label, they should also be part of the UDI-PI. 

------------------------------
Ronald Boumans
MDR Expert
Super PRRC
Netherlands
------------------------------

Original Message:
Sent: 03-Aug-2023 15:16
From: Anonymous Member
Subject: Expiration date AND/OR Manufacturing date.

This message was posted by a user wishing to remain anonymous

For a medical device with an expiration date, is it enough to indicate the expiration date in the product label, or should the manufacturing date be included as well?

REF , LOT, are included as well.

(for the US market)

Remember that "REF" per ISO 15223-1 / EN ISO 15223-1 (as amended) means catalog number.  Accordingly, the UDI-PI shall not encode for the REF.  Instead, the REF is encoded (if at all) within the UDI-DI.  If the REF is encoded within the UDI-PI, then that would be a nonconforming UDI-PI leading to the need for significant and costly corrective actions, up to and including, device recall.

And if the label contains an expiry date or LOT, then the UDI-PI for either the U.S. or Europe shall (not should) encode for those production variables (notwithstanding U.S. class I device exceptions).

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 07-Aug-2023 02:16
From: Ronald Boumans
Subject: Expiration date AND/OR Manufacturing date.

In the MDR, Annex VI, Section 3.5 says: If a lot number, serial number, software identification or expiry date appears on the label, it shall be part of the UDI-PI. If there is also a manufacturing date on the label, it does not need to be included in the UDI-PI. If there is only a manufacturing date on the label, this shall be used as the UDI-PI.

For UDI, the answer to your question would be that it would be sufficient to add the expiry date to the label and include in the UDI-PI. If REF and LOT are also on the label, they should also be part of the UDI-PI. 

------------------------------
Ronald Boumans
MDR Expert
Super PRRC
Netherlands

Original Message:
Sent: 03-Aug-2023 15:16
From: Anonymous Member
Subject: Expiration date AND/OR Manufacturing date.

This message was posted by a user wishing to remain anonymous

For a medical device with an expiration date, is it enough to indicate the expiration date in the product label, or should the manufacturing date be included as well?

REF , LOT, are included as well.

(for the US market)

This message was posted by a user wishing to remain anonymous

If using UDI, UDI format requires both manufacturing and expiry, I believe?

Hence, maybe you do need both on the label?

Original Message:
Sent: 03-Aug-2023 15:16
From: Anonymous Member
Subject: Expiration date AND/OR Manufacturing date.

This message was posted by a user wishing to remain anonymous

For a medical device with an expiration date, is it enough to indicate the expiration date in the product label, or should the manufacturing date be included as well?

REF , LOT, are included as well.

(for the US market)

For the U.S., the contents within the PI portion of the UDI are governed by what's on the label, not the other way around.  Label contents dictate UDI contents.  The UDI doesn't govern the label contents.  In other words, if the label contains both an expiration date and manufacturing date, then the UDI PI shall be encoded with both of those attributes accordingly.  But if the label contains no expiration date or no manufacturing date, then the UDI PI is not required to contain an expiration date or manufacturing date.  If the label contains one or the other, then the UDI PI shall be encoded with that one accordingly.

Europe's UDI requirements are different in that because the EU MDR requires the label to always contain either an expiry date or a manufacturing date, then the European UDI PI must always be encoded with either an expiration date or a manufacturing date.  So, whereas a U.S. UDI PI may encode for neither an expiration date nor a manufacturing date, a European UDI PI will in contrast always encode for one or the other. 

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 06-Aug-2023 21:19
From: Anonymous Member
Subject: Expiration date AND/OR Manufacturing date.

This message was posted by a user wishing to remain anonymous

If using UDI, UDI format requires both manufacturing and expiry, I believe?

Hence, maybe you do need both on the label?

Original Message:
Sent: 03-Aug-2023 15:16
From: Anonymous Member
Subject: Expiration date AND/OR Manufacturing date.

This message was posted by a user wishing to remain anonymous

For a medical device with an expiration date, is it enough to indicate the expiration date in the product label, or should the manufacturing date be included as well?

REF , LOT, are included as well.

(for the US market)

Remember also that the U.S. UDI regulations contain certain exceptions to the aforesaid rules with respect to class I devices. So, if the subject device is U.S. class I, then be sure to give due consideration to the corresponding adjusted UDI rules for that class and jurisdiction.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 07-Aug-2023 11:31
From: Kevin Randall
Subject: Expiration date AND/OR Manufacturing date.

For the U.S., the contents within the PI portion of the UDI are governed by what's on the label, not the other way around.  Label contents dictate UDI contents.  The UDI doesn't govern the label contents.  In other words, if the label contains both an expiration date and manufacturing date, then the UDI PI shall be encoded with both of those attributes accordingly.  But if the label contains no expiration date or no manufacturing date, then the UDI PI is not required to contain an expiration date or manufacturing date.  If the label contains one or the other, then the UDI PI shall be encoded with that one accordingly.

Europe's UDI requirements are different in that because the EU MDR requires the label to always contain either an expiry date or a manufacturing date, then the European UDI PI must always be encoded with either an expiration date or a manufacturing date.  So, whereas a U.S. UDI PI may encode for neither an expiration date nor a manufacturing date, a European UDI PI will in contrast always encode for one or the other. 

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 06-Aug-2023 21:19
From: Anonymous Member
Subject: Expiration date AND/OR Manufacturing date.

This message was posted by a user wishing to remain anonymous

If using UDI, UDI format requires both manufacturing and expiry, I believe?

Hence, maybe you do need both on the label?

Original Message:
Sent: 03-Aug-2023 15:16
From: Anonymous Member
Subject: Expiration date AND/OR Manufacturing date.

This message was posted by a user wishing to remain anonymous

For a medical device with an expiration date, is it enough to indicate the expiration date in the product label, or should the manufacturing date be included as well?

REF , LOT, are included as well.

(for the US market)

Dear Anon.

Date of manufacture is not a US requirement.  See reqiurements under 801 Labeling.

Regards,

------------------------------
D Michelle Williams
VP - Operations
United States
------------------------------

Original Message:
Sent: 03-Aug-2023 15:16
From: Anonymous Member
Subject: Expiration date AND/OR Manufacturing date.

This message was posted by a user wishing to remain anonymous

For a medical device with an expiration date, is it enough to indicate the expiration date in the product label, or should the manufacturing date be included as well?

REF , LOT, are included as well.

(for the US market)

FDA's 21 CFR Part 801 is an interesting regulation.  It specifically acknowledges the possible need for a manufacturing date or expiration date, yet it doesn't specifically demand these.  Nor does it directly demand labeling of other important attributes potentially required for safety and effectiveness such as storage conditions, control (lot/serial) number, catalog number, device name, hazardous material handling, biohazard precautions, and so on. But Part 801 does demand that the labeling contain adequate information for use and any relevant hazards and precautions or other adequate directions for use.  Indeed, these are the Part 801 buckets that, depending on the subject device's intrinsic safety and effectiveness needs, would constitute Part 801 requirements for attributes like manufacturing date, expiration date, etc.  If such attributes are appropriate for the subject device's intrinsic safety and effectiveness needs, then their omission from the label could render the device adulterated and/or misbranded under Part 801's (and other regulations', e.g., 820.30's) requirements for adequate information for use and any relevant hazards and precautions or other adequate directions for use.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 07-Aug-2023 11:49
From: D Michelle Williams
Subject: Expiration date AND/OR Manufacturing date.

Dear Anon.

Date of manufacture is not a US requirement.  See reqiurements under 801 Labeling.

Regards,

------------------------------
D Michelle Williams
VP - Operations
United States

Original Message:
Sent: 03-Aug-2023 15:16
From: Anonymous Member
Subject: Expiration date AND/OR Manufacturing date.

This message was posted by a user wishing to remain anonymous

For a medical device with an expiration date, is it enough to indicate the expiration date in the product label, or should the manufacturing date be included as well?

REF , LOT, are included as well.

(for the US market)

Good day all,

I believe that there are 3 different issues here:

1. To the initial question – if a device label contains an expiration date, does the label also need to include a manufacturing date?  Others have provided good insight into this.  The only other point I would make is that for some countries, e.g., China, manufacturing date is required to be on the label (having to do with when a device can be imported into that country).  This is why, for example, the GHTF/IMDRF UDI guidances – and by extension, the MDR/IVDR – have an exception for manufacturing date when it is not the only PI on the label [that is, manufacturing date is only on the label to meet certain country's requirements and not as a production control].
2. On manufacturing date and the MDR/IVDR – as others have stated, manufacturing date is required if there is not expiration date.  However, it is not required to be explicitly stated on the label – it "…may be included as part of the lot number or serial number, provided the date is clearly identifiable."
3. On REF number and UDI – though I do not recommend this practice – we do see, for example, catalog numbers encoded in the UDI barcoded (e.g., in GS1 using AI(240)) when needed, for example, for internal warehouse systems.  And I think this is preferred to multiple barcodes on the same label.  There have also been times where customers have requested that this number be included/encoded in the UDI barcode for their internal purposes.

Thanks,

Jay

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Jay Crowley
Vice President, Medical Devices and UDI Practice Lead
USDM Life Sciences
Baltimore MD
United States
------------------------------

Original Message:
Sent: 07-Aug-2023 12:29
From: Kevin Randall
Subject: Expiration date AND/OR Manufacturing date.

FDA's 21 CFR Part 801 is an interesting regulation.  It specifically acknowledges the possible need for a manufacturing date or expiration date, yet it doesn't specifically demand these.  Nor does it directly demand labeling of other important attributes potentially required for safety and effectiveness such as storage conditions, control (lot/serial) number, catalog number, device name, hazardous material handling, biohazard precautions, and so on. But Part 801 does demand that the labeling contain adequate information for use and any relevant hazards and precautions or other adequate directions for use.  Indeed, these are the Part 801 buckets that, depending on the subject device's intrinsic safety and effectiveness needs, would constitute Part 801 requirements for attributes like manufacturing date, expiration date, etc.  If such attributes are appropriate for the subject device's intrinsic safety and effectiveness needs, then their omission from the label could render the device adulterated and/or misbranded under Part 801's (and other regulations', e.g., 820.30's) requirements for adequate information for use and any relevant hazards and precautions or other adequate directions for use.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 07-Aug-2023 11:49
From: D Michelle Williams
Subject: Expiration date AND/OR Manufacturing date.

Dear Anon.

Date of manufacture is not a US requirement.  See reqiurements under 801 Labeling.

Regards,

------------------------------
D Michelle Williams
VP - Operations
United States

Original Message:
Sent: 03-Aug-2023 15:16
From: Anonymous Member
Subject: Expiration date AND/OR Manufacturing date.

This message was posted by a user wishing to remain anonymous

For a medical device with an expiration date, is it enough to indicate the expiration date in the product label, or should the manufacturing date be included as well?

REF , LOT, are included as well.

(for the US market)