FDA and NIOSH Approval - Packaging and Distribution of "Breathing Tubes"

[ChrissieO]

We are currently ISO9001:2008/TS16949/OHSAS18001/ISO14001. We are looking into taking over the packaging and distribution of "Respirators" and "breathing tubes" for one of our manufacturing plants.

We will need to be initially NIOSH approved and in the long term FDA. We have internal people that will help with this but I would like to be at least a little clued up on it before I meet with them.

I also have a meeting next week with our site manager to go through the implications of the above and as I am the quality co-ordinator it would help if I knew what I was talking about and was able to point out what will need to be done if we take on this new process.

We will not be going for our own 13485 registration but will be part of the manufacturing plants registration as a remote location.

All help greatly received.

Chrissie x

 

[MIREGMGR]

These presumably are medical devices per FDA definition. Is someone other than you responsible for them as Manufacturer/Marketer, and is that someone already a Registered Establishment and are the devices Listed?

If your role will be that of a contract manufacturer, but you participate in distribution, you may be required to be a Registered Establishment as well. You'll need to review the registration rules. The FDA is likely to want to know of each site that's involved.

Are your operations already GMP/QSR compliant?

I haven't checked the likely classification for these devices...are they FDA Class II? Will they be serialized, or batch tracked? Who will control the content on the labeling, will the appropriate tracking information be controlled and integrated with that labeling, and will the labeling otherwise be FDA compliant?

Will your processes for the devices be validated and/or verified? This would be of particular focus if the devices are to be distributed in sterile form. If so, will your processes for them... especially related to sterile barrier packaging, and sterilization processing if done by you or a subcontractor... be validated?

If you'll be conducting sterile barrier packaging, do you have an appropriate "cleanroom" facility and associated work processes ready to go, preferably with classification per ISO 14644?

Will there be distribution outside of the US? If so, I'd think you'd want to be up to speed on other regulatory systems' requirements as well, particularly in regard to issues that conflict with FDA requirements.

 

[ChrissieO]

These presumably are medical devices per FDA definition. Is someone other than you responsible for them as Manufacturer/Marketer, and is that someone already a Registered Establishment and are the devices Listed?

We will be receiving the finished product in "inner sterile packaging" from one of our own manufacturing plants which is FDA/NIOSH approved in its' own right.

If your role will be that of a contract manufacturer, but you participate in distribution, you may be required to be a Registered Establishment as well. You'll need to review the registration rules. The FDA is likely to want to know of each site that's involved.

Are your operations already GMP/QSR compliant?

We are only registered to the standards mentioned in my first post.

I haven't checked the likely classification for these devices...are they FDA Class II? Will they be serialized, or batch tracked? Who will control the content on the labeling, will the appropriate tracking information be controlled and integrated with that labeling, and will the labeling otherwise be FDA compliant?

As far as I can tell they are Class II.
Labelling will be produced by ourselves (barcode provided by source of supple which will include batch number.
They will be batch controlled and life usage controlled


Will your processes for the devices be validated and/or verified? This would be of particular focus if the devices are to be distributed in sterile form. If so, will your processes for them... especially related to sterile barrier packaging, and sterilization processing if done by you or a subcontractor... be validated?

We would like to be able to do release validation/verification from our site to avoid onward shipment back to SOS, after sending only the paperwork of the quality checks to the manufacturing plant for review and final release

If you'll be conducting sterile barrier packaging, do you have an appropriate "cleanroom" facility and associated work processes ready to go, preferably with classification per ISO 14644?

We will not be conducting sterile barrier packaging

Will there be distribution outside of the US? If so, I'd think you'd want to be up to speed on other regulatory systems' requirements as well, particularly in regard to issues that conflict with FDA requirements.

The product is manufactured here in the UK and distributed from here throughout the EU also with export to our Parent company in the US for distribution

These are all currently NIOSH approved product but we are just switching the outer packaging to a new location.

Chrissie

 

[MIREGMGR]

As I'm sure you know, NIOSH approval and FDA approval are neither interchangeable nor exclusionary. Within FDA jurisdiction, a respirator is a medical device if it is used in a medical context; see for instance product classes NZJ and MSH. This is a substantially different approach than that used in the EC, at least under the pre-2010 division of scope between the MDD and PPDD.

Since you mention that the existing production facility is "FDA approved", I assume that your organization doesn't restrict sales to exclude medical applications within the US, and doesn't state in the product labeling that the product is not to be used in medical applications. Given that assumption, I would think that FDA compliance would be required for these products as Class II medical devices, and that your facility as a contract manufacturer within your overall organization but as a participant in distribution would be obligated to be registered as an FDA Establishment (per 21 CFR 807.20, or http://www.fda.gov/MedicalDevices/D...urDevice/RegistrationandListing/ucm053165.htm), with an appropriate system of GMP/QSR compliance in place to encompass those elements of your operations that affect regulated aspects for these products. This of course would simply be an overall-system revision of the existing FDA compliance stance that I assume is in place at the existing facility.

 

[ChrissieO]

As I'm sure you know, NIOSH approval and FDA approval are neither interchangeable nor exclusionary. Within FDA jurisdiction, a respirator is a medical device if it is used in a medical context; see for instance product classes NZJ and MSH. This is a substantially different approach than that used in the EC, at least under the pre-2010 division of scope between the MDD and PPDD.

Since you mention that the existing production facility is "FDA approved", I assume that your organization doesn't restrict sales to exclude medical applications within the US, and doesn't state in the product labeling that the product is not to be used in medical applications. Given that assumption, I would think that FDA compliance would be required for these products as Class II medical devices, and that your facility as a contract manufacturer within your overall organization but as a participant in distribution would be obligated to be registered as an FDA Establishment (per 21 CFR 807.20, or http://www.fda.gov/MedicalDevices/D...urDevice/RegistrationandListing/ucm053165.htm), with an appropriate system of GMP/QSR compliance in place to encompass those elements of your operations that affect regulated aspects for these products. This of course would simply be an overall-system revision of the existing FDA compliance stance that I assume is in place at the existing facility.

Thank you for this information, it has however left me more confused than ever. NIOSH and FDA requirements are a totally new thing for me and to be honest, I don't really understand what you are saying.

After further discussion with our counterparts in the US and our manufacturing plant in the UK, we will only need NIOSH certification and meet the requirements at 42 CFR part 84. I have searched the FDA site and the NIOSH site but can not find what these requirements actually are so if someone could help me with this and point me in the right direction of somewhere that outlines the requirements in black and white, I would be very grateful.

Thanks

Chrissie

 

[ChrissieO]

The more I read up on this the more confused I am. Our manufacturing plant said that we would ne NIOSH certification to be able to pack a and ship from our operation.......................but do we?

The information I have found on the NIOSH and FDA websites only refers to certification of the product, which the manufactruing plant alread has.

All we want to do is to pack/label and ship to customer, surely we should be part of their remit and up to them to ensure that GMP is met by us.

Chrissie

 

[Michael Malis]

The more I read up on this the more confused I am. Our manufacturing plant said that we would ne NIOSH certification to be able to pack a and ship from our operation.......................but do we?

The information I have found on the NIOSH and FDA websites only refers to certification of the product, which the manufactruing plant alread has.

All we want to do is to pack/label and ship to customer, surely we should be part of their remit and up to them to ensure that GMP is met by us.

Chrissie

Let's try again.

What do you pack?
Inner packaging or outside packaging?
The product that you describe above is Medical Device and your packaging change is part that need to be validated and verified to make sure that package integrity was not modified...
i.e. How do you know that product is still sterile AFTER your change?
Is it possible that you potentially damage the product in any way?
Did you perform a Risk Analysis for this change?
Do you know if your new package configuration is acceptable in accordance to the latest packaging standard such as ISO 11607?

Please provide more information...

 

[ChrissieO]

Let's try again.

What do you pack?
Respirators & Breathing Tubes

Inner packaging or outside packaging?
Outside packaging

The product that you describe above is Medical Device and your packaging change is part that need to be validated and verified to make sure that package integrity was not modified...
i.e. How do you know that product is still sterile AFTER your change?
Is it possible that you potentially damage the product in any way?
Did you perform a Risk Analysis for this change?
This has been done by our manufacturing site quality personnel at our facility

Do you know if your new package configuration is acceptable in accordance to the latest packaging standard such as ISO 11607?
Packaging is acceptable in accordance with latest packaging standard and has/will be supplied by our own manufacturing plant.

Please provide more information...

These are not new products, but products we have manufactured for some time, the outer packaging was with an outside supplier until now and all we are trying to do is to bring them in house but at a seperate site to the manufacturing plant but because of the geographical location we need to be able to verify and ship from our site and not return them to the manufacturing plant for verification.

C

 

[Michael Malis]

These are not new products, but products we have manufactured for some time, the outer packaging was with an outside supplier until now and all we are trying to do is to bring them in house but at a seperate site to the manufacturing plant but because of the geographical location we need to be able to verify and ship from our site and not return them to the manufacturing plant for verification.

C

So the only change is that you bring the same (not different outside box)packaging in-house?
If the answer is yes, than you only need internal packaging validation and verification paperwork.
If the answer is no (you do have a new outside box) than you will need to accaptance to ISO 11607

 

[ChrissieO]

So the only change is that you bring the same (not different outside box)packaging in-house?
If the answer is yes, than you only need internal packaging validation and verification paperwork.
If the answer is no (you do have a new outside box) than you will need to accaptance to ISO 11607

yes, all we are doing is moving an established process from an outside supplier in to one of our sites, other than the manufacturing site, for outer packaging and labelling.

Cx