Regulatory Open Forum

Hi Virginia,

Re: cleanliness - I would start with risk management and determine what level of cleanliness is appropriate for your device.  Perhaps others have more detailed information in this area.

Re: biocompatibility
You are correct - there is a new standard which is specific to gas path contacting devices.  You can reference standards which are not on the consensus standards list.  To the best of my knowledge, FDA had a presence in the working group for the new standard so I can't imagine too much confusion.

However, with respect to ISO 10993-1, my experience has been that breathing tubes have been assessed as indirect patient contact devices (tissue/bone/dentin) based on the travel of the gases through the tubing into the patient's respiratory tract.  An indirect contact classification is consistent with the current guidance which states:
Indirect contact – term used for a device or device component through which a fluid or gas passes, prior to the fluid or gas coming into physical contact with body tissue (in this case the device or device component itself does not physically contact body tissue) (https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm348890.pdf).

More recently, I have seen requests for extractables and leachables testing and particulates testing, which is more representative of gas path contact devices than implantables testing.  Speaking with test labs, it sounds like type of request is fairly common of late.

If you have any concerns or uncertainty, you may want to consider a pre-submission in order to get feedback on your proposed test plan with FDA before paying a lot of money for testing / preparing a submission (and having to delay clearance due to inefficiencies or misunderstandings).  Guidance on the pre-submission program is available on the FDA website: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm311176.pdf.

Hope this helps!
Liz

Hi Virginia,

Re: cleanliness - I would start with risk management and determine what level of cleanliness is appropriate for your device.  Perhaps others have more detailed information in this area.

Re: biocompatibility
You are correct - there is a new standard which is specific to gas path contacting devices.  You can reference standards which are not on the consensus standards list.  To the best of my knowledge, FDA had a presence in the working group for the new standard so I can't imagine too much confusion.

However, with respect to ISO 10993-1, my experience has been that breathing tubes have been assessed as indirect patient contact devices (tissue/bone/dentin) based on the travel of the gases through the tubing into the patient's respiratory tract.  An indirect contact classification is consistent with the current guidance which states:
Indirect contact – term used for a device or device component through which a fluid or gas passes, prior to the fluid or gas coming into physical contact with body tissue (in this case the device or device component itself does not physically contact body tissue) (https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm348890.pdf).

More recently, I have seen requests for extractables and leachables testing and particulates testing, which is more representative of gas path contact devices than implantables testing.  Speaking with test labs, it sounds like type of request is fairly common of late.

If you have any concerns or uncertainty, you may want to consider a pre-submission in order to get feedback on your proposed test plan with FDA before paying a lot of money for testing / preparing a submission (and having to delay clearance due to inefficiencies or misunderstandings).  Guidance on the pre-submission program is available on the FDA website: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm311176.pdf.

Hope this helps!
Liz

Hi Virginia,

It sounds like you have a good plan!  Best of luck with your pre-sub!

Re: cleanliness, etc. - definitely not my area of expertise, but have a look at ISO 14644-1.  The standard will not apply in full, but I believe that there are clauses that might be of value to you.  I don't know of a complete standard that applies to your particular manufacturing situation (although I could be wrong - again, not my area of expertise).

ISO 14644-1:2015 - Cleanrooms and associated controlled environments -- Part 1: Classification of air cleanliness by particle concentration

-Liz

Hi Virginia,

Re: cleanliness - I would start with risk management and determine what level of cleanliness is appropriate for your device.  Perhaps others have more detailed information in this area.

Re: biocompatibility
You are correct - there is a new standard which is specific to gas path contacting devices.  You can reference standards which are not on the consensus standards list.  To the best of my knowledge, FDA had a presence in the working group for the new standard so I can't imagine too much confusion.

However, with respect to ISO 10993-1, my experience has been that breathing tubes have been assessed as indirect patient contact devices (tissue/bone/dentin) based on the travel of the gases through the tubing into the patient's respiratory tract.  An indirect contact classification is consistent with the current guidance which states:
Indirect contact – term used for a device or device component through which a fluid or gas passes, prior to the fluid or gas coming into physical contact with body tissue (in this case the device or device component itself does not physically contact body tissue) (https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm348890.pdf).

More recently, I have seen requests for extractables and leachables testing and particulates testing, which is more representative of gas path contact devices than implantables testing.  Speaking with test labs, it sounds like type of request is fairly common of late.

If you have any concerns or uncertainty, you may want to consider a pre-submission in order to get feedback on your proposed test plan with FDA before paying a lot of money for testing / preparing a submission (and having to delay clearance due to inefficiencies or misunderstandings).  Guidance on the pre-submission program is available on the FDA website: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm311176.pdf.

Hope this helps!
Liz

Hi Virginia,

It sounds like you have a good plan!  Best of luck with your pre-sub!

Re: cleanliness, etc. - definitely not my area of expertise, but have a look at ISO 14644-1.  The standard will not apply in full, but I believe that there are clauses that might be of value to you.  I don't know of a complete standard that applies to your particular manufacturing situation (although I could be wrong - again, not my area of expertise).

ISO 14644-1:2015 - Cleanrooms and associated controlled environments -- Part 1: Classification of air cleanliness by particle concentration

-Liz

Hi Virginia,

Re: cleanliness - I would start with risk management and determine what level of cleanliness is appropriate for your device.  Perhaps others have more detailed information in this area.

Re: biocompatibility
You are correct - there is a new standard which is specific to gas path contacting devices.  You can reference standards which are not on the consensus standards list.  To the best of my knowledge, FDA had a presence in the working group for the new standard so I can't imagine too much confusion.

However, with respect to ISO 10993-1, my experience has been that breathing tubes have been assessed as indirect patient contact devices (tissue/bone/dentin) based on the travel of the gases through the tubing into the patient's respiratory tract.  An indirect contact classification is consistent with the current guidance which states:
Indirect contact – term used for a device or device component through which a fluid or gas passes, prior to the fluid or gas coming into physical contact with body tissue (in this case the device or device component itself does not physically contact body tissue) (https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm348890.pdf).

More recently, I have seen requests for extractables and leachables testing and particulates testing, which is more representative of gas path contact devices than implantables testing.  Speaking with test labs, it sounds like type of request is fairly common of late.

If you have any concerns or uncertainty, you may want to consider a pre-submission in order to get feedback on your proposed test plan with FDA before paying a lot of money for testing / preparing a submission (and having to delay clearance due to inefficiencies or misunderstandings).  Guidance on the pre-submission program is available on the FDA website: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm311176.pdf.

Hope this helps!
Liz

Hi Virginia,

It sounds like you have a good plan!  Best of luck with your pre-sub!

Re: cleanliness, etc. - definitely not my area of expertise, but have a look at ISO 14644-1.  The standard will not apply in full, but I believe that there are clauses that might be of value to you.  I don't know of a complete standard that applies to your particular manufacturing situation (although I could be wrong - again, not my area of expertise).

ISO 14644-1:2015 - Cleanrooms and associated controlled environments -- Part 1: Classification of air cleanliness by particle concentration

-Liz

Hi Virginia,

Re: cleanliness - I would start with risk management and determine what level of cleanliness is appropriate for your device.  Perhaps others have more detailed information in this area.

Re: biocompatibility
You are correct - there is a new standard which is specific to gas path contacting devices.  You can reference standards which are not on the consensus standards list.  To the best of my knowledge, FDA had a presence in the working group for the new standard so I can't imagine too much confusion.

However, with respect to ISO 10993-1, my experience has been that breathing tubes have been assessed as indirect patient contact devices (tissue/bone/dentin) based on the travel of the gases through the tubing into the patient's respiratory tract.  An indirect contact classification is consistent with the current guidance which states:
Indirect contact – term used for a device or device component through which a fluid or gas passes, prior to the fluid or gas coming into physical contact with body tissue (in this case the device or device component itself does not physically contact body tissue) (https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm348890.pdf).

More recently, I have seen requests for extractables and leachables testing and particulates testing, which is more representative of gas path contact devices than implantables testing.  Speaking with test labs, it sounds like type of request is fairly common of late.

If you have any concerns or uncertainty, you may want to consider a pre-submission in order to get feedback on your proposed test plan with FDA before paying a lot of money for testing / preparing a submission (and having to delay clearance due to inefficiencies or misunderstandings).  Guidance on the pre-submission program is available on the FDA website: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm311176.pdf.

Hope this helps!
Liz