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This message was posted by a user wishing to remain anonymous

For US PMA-approved devices, 814.39 and FDA guidance is clear that 30-day notice is required for manufacturing method change that [may] affect safety and effectiveness.  What is unclear is whether a 30-day notice is required for such changes at a component supplier to the manufacturer. 

Supplier/manufacturer relationships are governed by quality/supplier agreements via Purchasing Controls (Subpart E) and Acceptance Activities (Subpart H) to ensure the received component meets specifications.  If a component supplier (in consultation with the manufacturer) makes a manufacturing process change (eg,  implements an updated piece of equipment on the line), completes all required testing/validation showing the change does not affect the delivered component, would a 30-day notice be required? 

If so, what regulation/guidance clearly describes the requirements for manufacturing method/process changes at component suppliers?

This message was posted by a user wishing to remain anonymous

Hi there, 

Thanks for posting as I have the same question.

There is reference to supply changes in the FDA Guidance "30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75- Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes". , however only changes to the supplier is discussed. 

I see this was posted in March, were you able to receive any additional information that you are willing to share?

Thank you

Original Message:
Sent: 24-Mar-2022 15:07
From: Anonymous Member
Subject: 30-day notice PMA

This message was posted by a user wishing to remain anonymous

For US PMA-approved devices, 814.39 and FDA guidance is clear that 30-day notice is required for manufacturing method change that [may] affect safety and effectiveness.  What is unclear is whether a 30-day notice is required for such changes at a component supplier to the manufacturer.

Supplier/manufacturer relationships are governed by quality/supplier agreements via Purchasing Controls (Subpart E) and Acceptance Activities (Subpart H) to ensure the received component meets specifications.  If a component supplier (in consultation with the manufacturer) makes a manufacturing process change (eg,  implements an updated piece of equipment on the line), completes all required testing/validation showing the change does not affect the delivered component, would a 30-day notice be required?

If so, what regulation/guidance clearly describes the requirements for manufacturing method/process changes at component suppliers?

You might find this guidance helpful:  "30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75- Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes" available today at https://www.fda.gov/media/72663/download 

This guidance discusses component suppliers and points out when specs are unchanged, a CBE-30 is needed "when the material was critical to the performance of the device, as determined by the manufacturer" or if not critical, only an annual report is needed. The guidance also states "Changes to the manufacturing procedure or method of manufacturing that do not affect the safety or effectiveness of the device must be submitted in the periodic report, that is usually referred to as an annual report."

Perhaps the annual report is sufficient when your supplier "makes a manufacturing process change (eg,  implements an updated piece of equipment on the line), completes all required testing/validation showing the change does not affect the delivered component"


------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com
------------------------------

Original Message:
Sent: 14-Jul-2022 14:46
From: Anonymous Member
Subject: 30-day notice PMA

This message was posted by a user wishing to remain anonymous

Hi there,

Thanks for posting as I have the same question.

There is reference to supply changes in the FDA Guidance "30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75- Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes". , however only changes to the supplier is discussed.

I see this was posted in March, were you able to receive any additional information that you are willing to share?

Thank you

Original Message:
Sent: 24-Mar-2022 15:07
From: Anonymous Member
Subject: 30-day notice PMA

This message was posted by a user wishing to remain anonymous

For US PMA-approved devices, 814.39 and FDA guidance is clear that 30-day notice is required for manufacturing method change that [may] affect safety and effectiveness.  What is unclear is whether a 30-day notice is required for such changes at a component supplier to the manufacturer.

Supplier/manufacturer relationships are governed by quality/supplier agreements via Purchasing Controls (Subpart E) and Acceptance Activities (Subpart H) to ensure the received component meets specifications.  If a component supplier (in consultation with the manufacturer) makes a manufacturing process change (eg,  implements an updated piece of equipment on the line), completes all required testing/validation showing the change does not affect the delivered component, would a 30-day notice be required?

If so, what regulation/guidance clearly describes the requirements for manufacturing method/process changes at component suppliers?

This message was posted by a user wishing to remain anonymous

Hi Joy, thanks for the response- I apologize to the original poster for piggy-backing off of your question, but maybe keeping this thread together will help others searching in the future. 

It seems the decision you referenced is listed under changes to actual suppliers (e.g, adding a new supplier) where the specs of the material is unchanged. What about supplier process/testing changes to a material that is qualified by the supplier? This would be an already existing supplier and therefore managed by quality/supplier agreements?

Would the decision follow the same workflow as manufacturer/product changes? Or are they not as high risk if we, the manufacturer, trust the qualification of the supplier and determined the raw material and therefore our product to not have a change in safety? I'm digging so much into this because we have been facing quite a few changes by the supplier or sub-supplier where the qualification information is not readily provided to us in order to properly evaluate their assessment and therefore our risk. 

Thank you so much for the input!

Original Message:
Sent: 15-Jul-2022 01:31
From: Joy Frestedt
Subject: 30-day notice PMA

You might find this guidance helpful:  "30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75- Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes" available today at https://www.fda.gov/media/72663/download

This guidance discusses component suppliers and points out when specs are unchanged, a CBE-30 is needed "when the material was critical to the performance of the device, as determined by the manufacturer" or if not critical, only an annual report is needed. The guidance also states "Changes to the manufacturing procedure or method of manufacturing that do not affect the safety or effectiveness of the device must be submitted in the periodic report, that is usually referred to as an annual report."

Perhaps the annual report is sufficient when your supplier "makes a manufacturing process change (eg,  implements an updated piece of equipment on the line), completes all required testing/validation showing the change does not affect the delivered component"


------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com

Original Message:
Sent: 14-Jul-2022 14:46
From: Anonymous Member
Subject: 30-day notice PMA

This message was posted by a user wishing to remain anonymous

Hi there,

Thanks for posting as I have the same question.

There is reference to supply changes in the FDA Guidance "30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75- Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes". , however only changes to the supplier is discussed.

I see this was posted in March, were you able to receive any additional information that you are willing to share?

Thank you

Original Message:
Sent: 24-Mar-2022 15:07
From: Anonymous Member
Subject: 30-day notice PMA

This message was posted by a user wishing to remain anonymous

For US PMA-approved devices, 814.39 and FDA guidance is clear that 30-day notice is required for manufacturing method change that [may] affect safety and effectiveness.  What is unclear is whether a 30-day notice is required for such changes at a component supplier to the manufacturer.

Supplier/manufacturer relationships are governed by quality/supplier agreements via Purchasing Controls (Subpart E) and Acceptance Activities (Subpart H) to ensure the received component meets specifications.  If a component supplier (in consultation with the manufacturer) makes a manufacturing process change (eg,  implements an updated piece of equipment on the line), completes all required testing/validation showing the change does not affect the delivered component, would a 30-day notice be required?

If so, what regulation/guidance clearly describes the requirements for manufacturing method/process changes at component suppliers?

This message was posted by a user wishing to remain anonymous

Just to clarify a couple of points on this response:

1) the "when the material was critical to performance..." phrase in FDA guidance refers to a supplier change (ie, a change in supplier of a critical material), not to a change of manufacturing process at an existing supplier, which was the original question, and remains somewhat vague in the regulations and guidance.

2) for accuracy of nomenclature, a 30d notice (814.39 (f)) is different from what I presume is meant by "CBE" (change being effected) which is for very specific cases via 814.39 (d).

Original Message:
Sent: 15-Jul-2022 01:31
From: Joy Frestedt
Subject: 30-day notice PMA

You might find this guidance helpful:  "30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75- Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes" available today at https://www.fda.gov/media/72663/download

This guidance discusses component suppliers and points out when specs are unchanged, a CBE-30 is needed "when the material was critical to the performance of the device, as determined by the manufacturer" or if not critical, only an annual report is needed. The guidance also states "Changes to the manufacturing procedure or method of manufacturing that do not affect the safety or effectiveness of the device must be submitted in the periodic report, that is usually referred to as an annual report."

Perhaps the annual report is sufficient when your supplier "makes a manufacturing process change (eg,  implements an updated piece of equipment on the line), completes all required testing/validation showing the change does not affect the delivered component"


------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com

Original Message:
Sent: 14-Jul-2022 14:46
From: Anonymous Member
Subject: 30-day notice PMA

This message was posted by a user wishing to remain anonymous

Hi there,

Thanks for posting as I have the same question.

There is reference to supply changes in the FDA Guidance "30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75- Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes". , however only changes to the supplier is discussed.

I see this was posted in March, were you able to receive any additional information that you are willing to share?

Thank you

Original Message:
Sent: 24-Mar-2022 15:07
From: Anonymous Member
Subject: 30-day notice PMA

This message was posted by a user wishing to remain anonymous

For US PMA-approved devices, 814.39 and FDA guidance is clear that 30-day notice is required for manufacturing method change that [may] affect safety and effectiveness.  What is unclear is whether a 30-day notice is required for such changes at a component supplier to the manufacturer.

Supplier/manufacturer relationships are governed by quality/supplier agreements via Purchasing Controls (Subpart E) and Acceptance Activities (Subpart H) to ensure the received component meets specifications.  If a component supplier (in consultation with the manufacturer) makes a manufacturing process change (eg,  implements an updated piece of equipment on the line), completes all required testing/validation showing the change does not affect the delivered component, would a 30-day notice be required?

If so, what regulation/guidance clearly describes the requirements for manufacturing method/process changes at component suppliers?

This message was posted by a user wishing to remain anonymous

There is not a lot of good information on this topic. Some companies will write a procedure that states they don't include such changes in 30-day or even annual report and leave that to the supplier and supplier audits. This choice is often selected for efficiency; however, it can catch up with you. Not only could FDA object, but a change that later necessitates a recall could occur because you didn't review changes sufficiently. It sounds like in your case you are reviewing it, which is good.

I agree with the other response that annual report might be a good middle ground. At least you are documenting, and FDA can ask you to convert to a 30-day if they object. They can't later accuse you of failing to inform them. I have used this method before.
Original Message:
Sent: 24-Mar-2022 15:07
From: Anonymous Member
Subject: 30-day notice PMA

This message was posted by a user wishing to remain anonymous

For US PMA-approved devices, 814.39 and FDA guidance is clear that 30-day notice is required for manufacturing method change that [may] affect safety and effectiveness.  What is unclear is whether a 30-day notice is required for such changes at a component supplier to the manufacturer.

Supplier/manufacturer relationships are governed by quality/supplier agreements via Purchasing Controls (Subpart E) and Acceptance Activities (Subpart H) to ensure the received component meets specifications.  If a component supplier (in consultation with the manufacturer) makes a manufacturing process change (eg,  implements an updated piece of equipment on the line), completes all required testing/validation showing the change does not affect the delivered component, would a 30-day notice be required?

If so, what regulation/guidance clearly describes the requirements for manufacturing method/process changes at component suppliers?

This message was posted by a user wishing to remain anonymous

This may be a center/reviewer-specific response, but we have been informed by our reviewers that they want 30-Day submissions for any  changes to the supplier manufacturing process for any components that we have designated as "critical components" in our quality system.  Changes to the manufacturing process of non-critical components are assessed for their significance and reported via the annual report or 30-day submission accordingly.

And yes, this has resulted in some pushback from suppliers complaining that "they don't have to do this for their other customers."  We include the requirement to support these sorts of submissions in the supplier agreements to get around that.
Original Message:
Sent: 24-Mar-2022 15:07
From: Anonymous Member
Subject: 30-day notice PMA

This message was posted by a user wishing to remain anonymous

For US PMA-approved devices, 814.39 and FDA guidance is clear that 30-day notice is required for manufacturing method change that [may] affect safety and effectiveness.  What is unclear is whether a 30-day notice is required for such changes at a component supplier to the manufacturer.

Supplier/manufacturer relationships are governed by quality/supplier agreements via Purchasing Controls (Subpart E) and Acceptance Activities (Subpart H) to ensure the received component meets specifications.  If a component supplier (in consultation with the manufacturer) makes a manufacturing process change (eg,  implements an updated piece of equipment on the line), completes all required testing/validation showing the change does not affect the delivered component, would a 30-day notice be required?

If so, what regulation/guidance clearly describes the requirements for manufacturing method/process changes at component suppliers?

This message was posted by a user wishing to remain anonymous

Interesting.  Has your Branch supported this request with the regulation that requires such submissions?  While most medical component suppliers do implement a quality system, 820 does not apply to component manufacturers, even if they are "critical" components. 

Is there a regulation that defines "critical" vs "non-critical components"? I see "critical" sort of defined in 30d notice guidance ("critical to the performance of the device") but I suspect many components, if non-functioning, could affect the performance of a device unless it is a component that is cosmetic only.

There are also practical issues with such a requirement if the component supplier is supplying a common off-the-shelf component to a small manufacturer.  For example, if I am using a Duracell battery in my device and designate this battery as a critical component (as clearly a battery failure would affect device performance), I doubt I'd be able to convince Duracell to inform me of every single change they make in their manufacturing processes so I could send in 30d notices to FDA.

It seems this is an area of regulation that could use some clarity from the Agency, as it appears many companies treat such changes differently.
Original Message:
Sent: 21-Jul-2022 14:40
From: Anonymous Member
Subject: 30-day notice PMA

This message was posted by a user wishing to remain anonymous

This may be a center/reviewer-specific response, but we have been informed by our reviewers that they want 30-Day submissions for any  changes to the supplier manufacturing process for any components that we have designated as "critical components" in our quality system.  Changes to the manufacturing process of non-critical components are assessed for their significance and reported via the annual report or 30-day submission accordingly.

And yes, this has resulted in some pushback from suppliers complaining that "they don't have to do this for their other customers."  We include the requirement to support these sorts of submissions in the supplier agreements to get around that.
Original Message:
Sent: 24-Mar-2022 15:07
From: Anonymous Member
Subject: 30-day notice PMA

This message was posted by a user wishing to remain anonymous

For US PMA-approved devices, 814.39 and FDA guidance is clear that 30-day notice is required for manufacturing method change that [may] affect safety and effectiveness.  What is unclear is whether a 30-day notice is required for such changes at a component supplier to the manufacturer.

Supplier/manufacturer relationships are governed by quality/supplier agreements via Purchasing Controls (Subpart E) and Acceptance Activities (Subpart H) to ensure the received component meets specifications.  If a component supplier (in consultation with the manufacturer) makes a manufacturing process change (eg,  implements an updated piece of equipment on the line), completes all required testing/validation showing the change does not affect the delivered component, would a 30-day notice be required?

If so, what regulation/guidance clearly describes the requirements for manufacturing method/process changes at component suppliers?