Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

We manufacture a single use, disposable, sterile medical device. Our labeling currently does not contain any storage condition information (such as protect from freezing, relative humidity guidelines and so forth). When is it appropriate to add storage condition information to product labeling and when should it be avoided? If storage condition information should be added, what standards/regulations provide guidance on this point?

Dear Anonymous,

If there aren't particular storage conditions to be communicated to the handler / user, the temperature symbol with environment temperature range can be placed on the label.
The reference standard for labelling symbols is ISO 15223.

Kind regards,

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Giulia Paolucci
MDR Expert
Basel
Switzerland
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Original Message:
Sent: 04-Jan-2022 13:08
From: Anonymous Member
Subject: Storage Conditions on Device Labeling

This message was posted by a user wishing to remain anonymous

We manufacture a single use, disposable, sterile medical device. Our labeling currently does not contain any storage condition information (such as protect from freezing, relative humidity guidelines and so forth). When is it appropriate to add storage condition information to product labeling and when should it be avoided? If storage condition information should be added, what standards/regulations provide guidance on this point?

Hi Anon,

storage and transport (and maybe storage again) are part of the medical device lifecycle and needs to be covered by risk management. Your risk analysis should identify whether environmental conditions like temperature, humidity, vibration may influence the conformance to product requirements during the lifetime of the medical device. As a control measure the limits of these environmental conditions can be made known via labelling, preferably with the use of harmonized symbols. Transport validations needs to confirm that the conditions can be met.

------------------------------
Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs | Head of Training
Arnhem
Netherlands
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Original Message:
Sent: 04-Jan-2022 13:08
From: Anonymous Member
Subject: Storage Conditions on Device Labeling

This message was posted by a user wishing to remain anonymous

We manufacture a single use, disposable, sterile medical device. Our labeling currently does not contain any storage condition information (such as protect from freezing, relative humidity guidelines and so forth). When is it appropriate to add storage condition information to product labeling and when should it be avoided? If storage condition information should be added, what standards/regulations provide guidance on this point?

Hello,

For a sterile product, storage parameters are generally considered for preconditioning when performing tests such as seal strength, package integrity, accelerated ageing, etc. so I would be surprised if they were not considered already. As such, you may want to look into those records to determine what has already been considered and update your labeling accordingly. 

You may also want to consider the requirements in ISO 20417 Medical Devices - Information to be Supplied by the Manufacturer.

------------------------------
Wade Munsch
Regulatory Affairs Manager
Houston TX
United States
------------------------------

Original Message:
Sent: 04-Jan-2022 13:08
From: Anonymous Member
Subject: Storage Conditions on Device Labeling

This message was posted by a user wishing to remain anonymous

We manufacture a single use, disposable, sterile medical device. Our labeling currently does not contain any storage condition information (such as protect from freezing, relative humidity guidelines and so forth). When is it appropriate to add storage condition information to product labeling and when should it be avoided? If storage condition information should be added, what standards/regulations provide guidance on this point?

This message was posted by a user wishing to remain anonymous

Thank you all for the comments. I think what is not clear is how the extremes tested during shipping validations and the other conditioning conducted as part of product performance testing translate into storage conditions on the labeling. If no issues are encountered in the shipping validation which tests conditions that could be encountered via truck, sea or air shipments, should no storage conditions be noted? Or does the storage conditions included on the labeling stem more from the storage conditions encountered during real time aging? What information does the FDA normally ask to review in relation to storage conditions noted on labeling?
Original Message:
Sent: 06-Jan-2022 07:32
From: Wade Munsch
Subject: Storage Conditions on Device Labeling

Hello,

For a sterile product, storage parameters are generally considered for preconditioning when performing tests such as seal strength, package integrity, accelerated ageing, etc. so I would be surprised if they were not considered already. As such, you may want to look into those records to determine what has already been considered and update your labeling accordingly.

You may also want to consider the requirements in ISO 20417 Medical Devices - Information to be Supplied by the Manufacturer.

------------------------------
Wade Munsch
Regulatory Affairs Manager
Houston TX
United States

Original Message:
Sent: 04-Jan-2022 13:08
From: Anonymous Member
Subject: Storage Conditions on Device Labeling

This message was posted by a user wishing to remain anonymous

We manufacture a single use, disposable, sterile medical device. Our labeling currently does not contain any storage condition information (such as protect from freezing, relative humidity guidelines and so forth). When is it appropriate to add storage condition information to product labeling and when should it be avoided? If storage condition information should be added, what standards/regulations provide guidance on this point?

It is important to remember there are actually two shipping ratings. One is for you, the manufacturer, and is not placed on the package. This is what you tested during shipping validation and is used, by you, to select the appropriate shipping method and speed.

The second rating is marked on the labeling and is intended for the end user. They need to know how to transport and store the device after taking delivery. These markings can be different (and usually are) than the extremes you use for shipping validation. You should consider the rating of the parts which comprise your device and the transport/storage testing you conducted. Real time aging is usually performed at a single set temperature and humidity and is for packaging validation of a sterile barrier so the parameters used in real time aging would not necessarily reflect the transport and storage conditions.

------------------------------
Wade Munsch
Regulatory Affairs Manager, Biotex, Inc.
Houston TX
United States
------------------------------

Original Message:
Sent: 12-Jan-2022 10:13
From: Anonymous Member
Subject: Storage Conditions on Device Labeling

This message was posted by a user wishing to remain anonymous

Thank you all for the comments. I think what is not clear is how the extremes tested during shipping validations and the other conditioning conducted as part of product performance testing translate into storage conditions on the labeling. If no issues are encountered in the shipping validation which tests conditions that could be encountered via truck, sea or air shipments, should no storage conditions be noted? Or does the storage conditions included on the labeling stem more from the storage conditions encountered during real time aging? What information does the FDA normally ask to review in relation to storage conditions noted on labeling?
Original Message:
Sent: 06-Jan-2022 07:32
From: Wade Munsch
Subject: Storage Conditions on Device Labeling

Hello,

For a sterile product, storage parameters are generally considered for preconditioning when performing tests such as seal strength, package integrity, accelerated ageing, etc. so I would be surprised if they were not considered already. As such, you may want to look into those records to determine what has already been considered and update your labeling accordingly.

You may also want to consider the requirements in ISO 20417 Medical Devices - Information to be Supplied by the Manufacturer.

------------------------------
Wade Munsch
Regulatory Affairs Manager
Houston TX
United States

Original Message:
Sent: 04-Jan-2022 13:08
From: Anonymous Member
Subject: Storage Conditions on Device Labeling

This message was posted by a user wishing to remain anonymous

We manufacture a single use, disposable, sterile medical device. Our labeling currently does not contain any storage condition information (such as protect from freezing, relative humidity guidelines and so forth). When is it appropriate to add storage condition information to product labeling and when should it be avoided? If storage condition information should be added, what standards/regulations provide guidance on this point?