Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi I'm hoping someone can help with this query regarding annual facility registration for the FDA .

Our product is a  re-usable electrical device that is 510k cleared and manufactured at an FDA registered facility for the finished device. The device is shipped with a supply of  disposable consumables that are required to prepare the skin before using the device. The  consumable  is  single use whereas the device has multiple uses over a period of years.

The consumable supplier ships to our Finished Device manufacturing site and they include a supply of the consumables with the device. The consumable supplier is approved on the manufacturers Approved Supplier List but is not an FDA registered site. So far I believe we are OK.

My question is in connection to shipping replacement consumables to customers and whether the consumable supplier needs to be a registered FDA facility to do this.  

If registered facility is required one option we are looking at is to have the consumable supplier ship the replacement consumables to our manufacturer and get them to pack and label - and ship to customers.

The guidance in FDA was not very clear to me :
(6) Manufactures components or accessories that are ready to be used for any intended health-related purpose and are packaged or labeled for commercial distribution for such health-related purpose, e.g. blood filters, hemodialysis tubing, or devices which of necessity must be further processed by a licensed practitioner or other qualified person to meet the needs of a particular patient, e.g., a manufacturer of ophthalmic lens blanks.

Any opinions are welcome.
Mike

Did the company officially classify the consumable as a component or an accessory? The guidance separately defines each term.

If a component, then I agree that the supplier may not have to be registered for that particular component. The component is on the BOM of the classified parent medical device.

If an accessory, then the supplier should be registered with the Agency because accessories, per the guidance, can be a standalone medical devices.

------------------------------
Timothy Kline, Ph.D., RAC
------------------------------

Original Message:
Sent: 11-Oct-2018 12:15
From: Anonymous Member
Subject: Facility registration for the FDA - consumable component shipped as spares

This message was posted by a user wishing to remain anonymous

Hi I'm hoping someone can help with this query regarding annual facility registration for the FDA .

Our product is a  re-usable electrical device that is 510k cleared and manufactured at an FDA registered facility for the finished device. The device is shipped with a supply of  disposable consumables that are required to prepare the skin before using the device. The  consumable  is  single use whereas the device has multiple uses over a period of years.

The consumable supplier ships to our Finished Device manufacturing site and they include a supply of the consumables with the device. The consumable supplier is approved on the manufacturers Approved Supplier List but is not an FDA registered site. So far I believe we are OK.

My question is in connection to shipping replacement consumables to customers and whether the consumable supplier needs to be a registered FDA facility to do this.

If registered facility is required one option we are looking at is to have the consumable supplier ship the replacement consumables to our manufacturer and get them to pack and label - and ship to customers.

The guidance in FDA was not very clear to me :
(6) Manufactures components or accessories that are ready to be used for any intended health-related purpose and are packaged or labeled for commercial distribution for such health-related purpose, e.g. blood filters, hemodialysis tubing, or devices which of necessity must be further processed by a licensed practitioner or other qualified person to meet the needs of a particular patient, e.g., a manufacturer of ophthalmic lens blanks.

Any opinions are welcome.
Mike

Hi Timothy
Thank you for your response to this question

I believe our consumable meets the definition of component. It is on the BOM of the classified parent medical device and the parent medical device is not to be used without using the consumable/component. The consumable itself cannot be used for an "intended health-related purpose" on its own but must be used as part of the parent medical device.
As well as providing a supply of the consumable with the device, users will also be able to purchase replacement consumables.

FDA state in their " Who Must Register, List and Pay the Fee"
"Manufacturer of accessories or components that are packaged or labeled for commercial distribution for health-related purposes to an end user"
and
(6) Manufactures components or accessories that are ready to be used for any intended health-related purpose and are packaged or labeled for commercial distribution for such health-related purpose, e.g. blood filters, hemodialysis tubing, or devices which of necessity must be further processed by a licensed practitioner or other qualified person to meet the needs of a particular patient, e.g., a manufacturer of ophthalmic lens blanks.

This is what prompted my question as to whether the supplier of our consumables are required to be registered FDA site.

I'm thinking now that since the component cannot be used on its own for health-related purposes then registration is not a requirement.

Any thoughts would be welcome.

regards

------------------------------
Mike Kilkelly
Quality Manager
Galway
Ireland
------------------------------

Original Message:
Sent: 12-Oct-2018 05:15
From: Timothy Kline
Subject: Facility registration for the FDA - consumable component shipped as spares

Did the company officially classify the consumable as a component or an accessory? The guidance separately defines each term.

If a component, then I agree that the supplier may not have to be registered for that particular component. The component is on the BOM of the classified parent medical device.

If an accessory, then the supplier should be registered with the Agency because accessories, per the guidance, can be a standalone medical devices.

------------------------------
Timothy Kline, Ph.D., RAC

Original Message:
Sent: 11-Oct-2018 12:15
From: Anonymous Member
Subject: Facility registration for the FDA - consumable component shipped as spares

This message was posted by a user wishing to remain anonymous

Hi I'm hoping someone can help with this query regarding annual facility registration for the FDA .

Our product is a  re-usable electrical device that is 510k cleared and manufactured at an FDA registered facility for the finished device. The device is shipped with a supply of  disposable consumables that are required to prepare the skin before using the device. The  consumable  is  single use whereas the device has multiple uses over a period of years.

The consumable supplier ships to our Finished Device manufacturing site and they include a supply of the consumables with the device. The consumable supplier is approved on the manufacturers Approved Supplier List but is not an FDA registered site. So far I believe we are OK.

My question is in connection to shipping replacement consumables to customers and whether the consumable supplier needs to be a registered FDA facility to do this.

If registered facility is required one option we are looking at is to have the consumable supplier ship the replacement consumables to our manufacturer and get them to pack and label - and ship to customers.

The guidance in FDA was not very clear to me :
(6) Manufactures components or accessories that are ready to be used for any intended health-related purpose and are packaged or labeled for commercial distribution for such health-related purpose, e.g. blood filters, hemodialysis tubing, or devices which of necessity must be further processed by a licensed practitioner or other qualified person to meet the needs of a particular patient, e.g., a manufacturer of ophthalmic lens blanks.

Any opinions are welcome.
Mike

Hi Timothy
Thank you for your response to this question

I believe our consumable meets the definition of component. It is on the BOM of the classified parent medical device and the parent medical device is not to be used without using the consumable/component. The consumable itself cannot be used for an "intended health-related purpose" on its own but must be used as part of the parent medical device.
As well as providing a supply of the consumable with the device, users will also be able to purchase replacement consumables.

FDA state in their " Who Must Register, List and Pay the Fee"
"Manufacturer of accessories or components that are packaged or labeled for commercial distribution for health-related purposes to an end user"
and
(6) Manufactures components or accessories that are ready to be used for any intended health-related purpose and are packaged or labeled for commercial distribution for such health-related purpose, e.g. blood filters, hemodialysis tubing, or devices which of necessity must be further processed by a licensed practitioner or other qualified person to meet the needs of a particular patient, e.g., a manufacturer of ophthalmic lens blanks.

This is what prompted my question as to whether the supplier of our consumables are required to be registered FDA site.

I'm thinking now that since the component cannot be used on its own for health-related purposes then registration is not a requirement.

Any thoughts would be welcome.

regards

------------------------------
Mike Kilkelly
Quality Manager
Galway
Ireland
------------------------------

Original Message:
Sent: 12-Oct-2018 05:15
From: Timothy Kline
Subject: Facility registration for the FDA - consumable component shipped as spares

Did the company officially classify the consumable as a component or an accessory? The guidance separately defines each term.

If a component, then I agree that the supplier may not have to be registered for that particular component. The component is on the BOM of the classified parent medical device.

If an accessory, then the supplier should be registered with the Agency because accessories, per the guidance, can be a standalone medical devices.

------------------------------
Timothy Kline, Ph.D., RAC

Original Message:
Sent: 11-Oct-2018 12:15
From: Anonymous Member
Subject: Facility registration for the FDA - consumable component shipped as spares

This message was posted by a user wishing to remain anonymous

Hi I'm hoping someone can help with this query regarding annual facility registration for the FDA .

Our product is a  re-usable electrical device that is 510k cleared and manufactured at an FDA registered facility for the finished device. The device is shipped with a supply of  disposable consumables that are required to prepare the skin before using the device. The  consumable  is  single use whereas the device has multiple uses over a period of years.

The consumable supplier ships to our Finished Device manufacturing site and they include a supply of the consumables with the device. The consumable supplier is approved on the manufacturers Approved Supplier List but is not an FDA registered site. So far I believe we are OK.

My question is in connection to shipping replacement consumables to customers and whether the consumable supplier needs to be a registered FDA facility to do this.

If registered facility is required one option we are looking at is to have the consumable supplier ship the replacement consumables to our manufacturer and get them to pack and label - and ship to customers.

The guidance in FDA was not very clear to me :
(6) Manufactures components or accessories that are ready to be used for any intended health-related purpose and are packaged or labeled for commercial distribution for such health-related purpose, e.g. blood filters, hemodialysis tubing, or devices which of necessity must be further processed by a licensed practitioner or other qualified person to meet the needs of a particular patient, e.g., a manufacturer of ophthalmic lens blanks.

Any opinions are welcome.
Mike

​The component does not need to be "used on its own."  I think that is something that you have inserted into the requirement.  Any component that has a health related purpose and is sold to an end user requires registration and listing.  For example, if I am selling a general purpose caster, this does not require registration and listing.  However, if I am selling a caster that is targeted as a replacement for hospital beds and I am selling this product to hospitals (not the OEM of the bed), then this does require registration and listing.  The caster cannot be "used on its own" for a health related purpose, but in the latter case, it DOES have a health related purpose.

------------------------------
Michael Winter RAC
Sr. Director, Quality and Regulatory Affairs
Curbell Medical
Alden NY
United States
------------------------------

Original Message:
Sent: 18-Oct-2018 07:00
From: Mike Kilkelly
Subject: Facility registration for the FDA - consumable component shipped as spares

Hi Timothy
Thank you for your response to this question

I believe our consumable meets the definition of component. It is on the BOM of the classified parent medical device and the parent medical device is not to be used without using the consumable/component. The consumable itself cannot be used for an "intended health-related purpose" on its own but must be used as part of the parent medical device.
As well as providing a supply of the consumable with the device, users will also be able to purchase replacement consumables.

FDA state in their " Who Must Register, List and Pay the Fee"
"Manufacturer of accessories or components that are packaged or labeled for commercial distribution for health-related purposes to an end user"
and
(6) Manufactures components or accessories that are ready to be used for any intended health-related purpose and are packaged or labeled for commercial distribution for such health-related purpose, e.g. blood filters, hemodialysis tubing, or devices which of necessity must be further processed by a licensed practitioner or other qualified person to meet the needs of a particular patient, e.g., a manufacturer of ophthalmic lens blanks.

This is what prompted my question as to whether the supplier of our consumables are required to be registered FDA site.

I'm thinking now that since the component cannot be used on its own for health-related purposes then registration is not a requirement.

Any thoughts would be welcome.

regards

------------------------------
Mike Kilkelly
Quality Manager
Galway
Ireland

Original Message:
Sent: 12-Oct-2018 05:15
From: Timothy Kline
Subject: Facility registration for the FDA - consumable component shipped as spares

Did the company officially classify the consumable as a component or an accessory? The guidance separately defines each term.

If a component, then I agree that the supplier may not have to be registered for that particular component. The component is on the BOM of the classified parent medical device.

If an accessory, then the supplier should be registered with the Agency because accessories, per the guidance, can be a standalone medical devices.

------------------------------
Timothy Kline, Ph.D., RAC

Original Message:
Sent: 11-Oct-2018 12:15
From: Anonymous Member
Subject: Facility registration for the FDA - consumable component shipped as spares

This message was posted by a user wishing to remain anonymous

Hi I'm hoping someone can help with this query regarding annual facility registration for the FDA .

Our product is a  re-usable electrical device that is 510k cleared and manufactured at an FDA registered facility for the finished device. The device is shipped with a supply of  disposable consumables that are required to prepare the skin before using the device. The  consumable  is  single use whereas the device has multiple uses over a period of years.

The consumable supplier ships to our Finished Device manufacturing site and they include a supply of the consumables with the device. The consumable supplier is approved on the manufacturers Approved Supplier List but is not an FDA registered site. So far I believe we are OK.

My question is in connection to shipping replacement consumables to customers and whether the consumable supplier needs to be a registered FDA facility to do this.

If registered facility is required one option we are looking at is to have the consumable supplier ship the replacement consumables to our manufacturer and get them to pack and label - and ship to customers.

The guidance in FDA was not very clear to me :
(6) Manufactures components or accessories that are ready to be used for any intended health-related purpose and are packaged or labeled for commercial distribution for such health-related purpose, e.g. blood filters, hemodialysis tubing, or devices which of necessity must be further processed by a licensed practitioner or other qualified person to meet the needs of a particular patient, e.g., a manufacturer of ophthalmic lens blanks.

Any opinions are welcome.
Mike

This message was posted by a user wishing to remain anonymous

Thank you for the very valuable input.

Let me explain my use of the "use on its own". It is my phrasing in an attempt to explain the thought process.

FDA requirement for registration:
(6) Manufactures components or accessories that are ready to be used for any intended health-related purpose and are packaged or labeled for commercial distribution for such health-related purpose, e.g. blood filters, hemodialysis tubing, or devices which of necessity must be further processed by a licensed practitioner or other qualified person to meet the needs of a particular patient, e.g., a manufacturer of ophthalmic lens blanks.


The phrase "use on its own"  is an interpretation of "ready to be used...  for any intended health-related purpose"

In the above example of the castor sold as a replacement component for a bed,  the castor itself as supplied to the end user might be determined not to be "ready to be used" for any intended health-related purpose. It needs to be assembled into the device before it is ready to be used for any intended health-related purpose.


Any thoughts?
Original Message:
Sent: 19-Oct-2018 07:40
From: Michael Winter
Subject: Facility registration for the FDA - consumable component shipped as spares

​The component does not need to be "used on its own."  I think that is something that you have inserted into the requirement.  Any component that has a health related purpose and is sold to an end user requires registration and listing.  For example, if I am selling a general purpose caster, this does not require registration and listing.  However, if I am selling a caster that is targeted as a replacement for hospital beds and I am selling this product to hospitals (not the OEM of the bed), then this does require registration and listing.  The caster cannot be "used on its own" for a health related purpose, but in the latter case, it DOES have a health related purpose.

------------------------------
Michael Winter RAC
Sr. Director, Quality and Regulatory Affairs
Curbell Medical
Alden NY
United States

Original Message:
Sent: 18-Oct-2018 07:00
From: Mike Kilkelly
Subject: Facility registration for the FDA - consumable component shipped as spares

Hi Timothy
Thank you for your response to this question

I believe our consumable meets the definition of component. It is on the BOM of the classified parent medical device and the parent medical device is not to be used without using the consumable/component. The consumable itself cannot be used for an "intended health-related purpose" on its own but must be used as part of the parent medical device.
As well as providing a supply of the consumable with the device, users will also be able to purchase replacement consumables.

FDA state in their " Who Must Register, List and Pay the Fee"
"Manufacturer of accessories or components that are packaged or labeled for commercial distribution for health-related purposes to an end user"
and
(6) Manufactures components or accessories that are ready to be used for any intended health-related purpose and are packaged or labeled for commercial distribution for such health-related purpose, e.g. blood filters, hemodialysis tubing, or devices which of necessity must be further processed by a licensed practitioner or other qualified person to meet the needs of a particular patient, e.g., a manufacturer of ophthalmic lens blanks.

This is what prompted my question as to whether the supplier of our consumables are required to be registered FDA site.

I'm thinking now that since the component cannot be used on its own for health-related purposes then registration is not a requirement.

Any thoughts would be welcome.

regards

------------------------------
Mike Kilkelly
Quality Manager
Galway
Ireland

Original Message:
Sent: 12-Oct-2018 05:15
From: Timothy Kline
Subject: Facility registration for the FDA - consumable component shipped as spares

Did the company officially classify the consumable as a component or an accessory? The guidance separately defines each term.

If a component, then I agree that the supplier may not have to be registered for that particular component. The component is on the BOM of the classified parent medical device.

If an accessory, then the supplier should be registered with the Agency because accessories, per the guidance, can be a standalone medical devices.

------------------------------
Timothy Kline, Ph.D., RAC

Original Message:
Sent: 11-Oct-2018 12:15
From: Anonymous Member
Subject: Facility registration for the FDA - consumable component shipped as spares

This message was posted by a user wishing to remain anonymous

Hi I'm hoping someone can help with this query regarding annual facility registration for the FDA .

Our product is a  re-usable electrical device that is 510k cleared and manufactured at an FDA registered facility for the finished device. The device is shipped with a supply of  disposable consumables that are required to prepare the skin before using the device. The  consumable  is  single use whereas the device has multiple uses over a period of years.

The consumable supplier ships to our Finished Device manufacturing site and they include a supply of the consumables with the device. The consumable supplier is approved on the manufacturers Approved Supplier List but is not an FDA registered site. So far I believe we are OK.

My question is in connection to shipping replacement consumables to customers and whether the consumable supplier needs to be a registered FDA facility to do this.

If registered facility is required one option we are looking at is to have the consumable supplier ship the replacement consumables to our manufacturer and get them to pack and label - and ship to customers.

The guidance in FDA was not very clear to me :
(6) Manufactures components or accessories that are ready to be used for any intended health-related purpose and are packaged or labeled for commercial distribution for such health-related purpose, e.g. blood filters, hemodialysis tubing, or devices which of necessity must be further processed by a licensed practitioner or other qualified person to meet the needs of a particular patient, e.g., a manufacturer of ophthalmic lens blanks.

Any opinions are welcome.
Mike