Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear Community,

We (Company A) are procuring a custom Procedure Pack from a US-based Procedure Pack Producer (PPP). The procedure pack will be OEM labelled by the PPP, shipped to Europe, consolidated with Company A's product (Class 2), and packaged in an outer shelf carton with Company A labeling. The PPP will be the legal manufacturer of the Procedure Pack and will have full responsibility for all regulatory approvals and PMS. The final consolidated product will be shipped to the US for distribution under Company A's 510(k).

Does anyone have any experience with a similar distribution chain and what regulatory challenges do you foresee?

In terms of a Supplier or Quality agreement between both parties, does anyone have a template they can share or what are the typical clauses that need to be captured?

Thanks in advance for your assistance.

If I'm understanding your scenario correctly, the final regulatory jurisdiction for marketing of "the final consolidated product" is the United States medical device jurisdiction.  Presuming that to be true, here are a few first thoughts:

• FDA doesn't officially use or define the term "Procedure Pack".  Instead, it "official" (by way of guidance) uses the term "Convenience Kit" and so its Convenience Kit policy needs to be consulted and met. I use the term "Convenience Kit" hereinafter rather than Procedure Pack when I refer to corresponding regulatory requirements (but I still use your terminology in respect of the name you've given to the product itself).

• Your scenario appears to involve three distinct medical device products the regulatory requirements for which all need to be met in their own respects:

1. 1. "Custom Procedure Pack" made and labeled by and for Company B where this Pack doesn't include Company A's 510(k)-cleared device as an integrated constituent.  This Custom Procedure Pack may either be a) an FDA Convenience Kit or else b) a finished medical device itself consisting of various components.
   2. Company A's 510(k)-cleared device for which no further regulatory clearance is needed as long as it is only packaged, labeled. marketed, etc., in strict accordance with the corresponding parameters established in its 510(k).  Any deviations require a new regulatory consideration and possibly a new 510(k) where such new 510(k) may overlap with what might be needed for item three below.
   3. "Final consolidated product" which is a third labeled medical device product considered to be a distinct product in its own right compared to the prior two products.  That third product may either be a) a second FDA Convenience Kit or else b) a new finished medical device consisting of two components: the Custom Procedure Pack made by Company B and the device made by Company A.

The applicable regulatory requirements covering ALL of the aforesaid three product configurations (including picking either option a or b for configurations 1 and 3) need to be distinctly met.  We would need more details to precisely write a corresponding regulatory strategy.

The Supplier or Quality Agreement between the parties will need to be fashioned dependent on which of the aforesaid regulatory pathways would be employed to cover all of the aforesaid product configuration questions.

Remember also that there will likely be particular quality management system obligations to be met as well.  The foregoing overview is focused solely on the premarket regulatory submission angles which can't ultimately be met without preceding quality management system support.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 06-Feb-2024 11:18
From: Anonymous Member
Subject: Procedure Pack Producer Quality Agreement

This message was posted by a user wishing to remain anonymous

Dear Community,

We (Company A) are procuring a custom Procedure Pack from a US-based Procedure Pack Producer (PPP). The procedure pack will be OEM labelled by the PPP, shipped to Europe, consolidated with Company A's product (Class 2), and packaged in an outer shelf carton with Company A labeling. The PPP will be the legal manufacturer of the Procedure Pack and will have full responsibility for all regulatory approvals and PMS. The final consolidated product will be shipped to the US for distribution under Company A's 510(k).

Does anyone have any experience with a similar distribution chain and what regulatory challenges do you foresee?

In terms of a Supplier or Quality agreement between both parties, does anyone have a template they can share or what are the typical clauses that need to be captured?

Thanks in advance for your assistance.

Hi Anon,

It sounds like only Company A is involved, so also not clear on the question or situation around Agreements.  Typically a Procedure Pack or Convenience Kit (as referred to by US FDA) would be a number of finished devices put together into one "pack" or "kit" for the convenience of the user.  In most situations there would not need to be an Agreement with the original manufacturers, because the medical devices or IVDs put into the kit retain their own identity, labelling, and regulatory status.  There may need to be business agreements if Company A is taking Company B, C, and D products and put them all together - then labelling something else or different.  And they might have their own requirements to be met.  Also keep in mind, if a company is only putting Product A, B, C, and D together and shipping it that way for the end user, I would defer this is only a shipping method and not a Procedure Pack.  Further clarification would be needed to understand how everything is being put together and labelled.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Consultant
Oriel STAT A MATRIX - ENTERPRISE
------------------------------

Original Message:
Sent: 06-Feb-2024 16:15
From: Kevin Randall
Subject: Procedure Pack Producer Quality Agreement

If I'm understanding your scenario correctly, the final regulatory jurisdiction for marketing of "the final consolidated product" is the United States medical device jurisdiction.  Presuming that to be true, here are a few first thoughts:

• FDA doesn't officially use or define the term "Procedure Pack".  Instead, it "official" (by way of guidance) uses the term "Convenience Kit" and so its Convenience Kit policy needs to be consulted and met. I use the term "Convenience Kit" hereinafter rather than Procedure Pack when I refer to corresponding regulatory requirements (but I still use your terminology in respect of the name you've given to the product itself).

• Your scenario appears to involve three distinct medical device products the regulatory requirements for which all need to be met in their own respects:

1. 1. "Custom Procedure Pack" made and labeled by and for Company B where this Pack doesn't include Company A's 510(k)-cleared device as an integrated constituent.  This Custom Procedure Pack may either be a) an FDA Convenience Kit or else b) a finished medical device itself consisting of various components.
   2. Company A's 510(k)-cleared device for which no further regulatory clearance is needed as long as it is only packaged, labeled. marketed, etc., in strict accordance with the corresponding parameters established in its 510(k).  Any deviations require a new regulatory consideration and possibly a new 510(k) where such new 510(k) may overlap with what might be needed for item three below.
   3. "Final consolidated product" which is a third labeled medical device product considered to be a distinct product in its own right compared to the prior two products.  That third product may either be a) a second FDA Convenience Kit or else b) a new finished medical device consisting of two components: the Custom Procedure Pack made by Company B and the device made by Company A.

The applicable regulatory requirements covering ALL of the aforesaid three product configurations (including picking either option a or b for configurations 1 and 3) need to be distinctly met.  We would need more details to precisely write a corresponding regulatory strategy.

The Supplier or Quality Agreement between the parties will need to be fashioned dependent on which of the aforesaid regulatory pathways would be employed to cover all of the aforesaid product configuration questions.

Remember also that there will likely be particular quality management system obligations to be met as well.  The foregoing overview is focused solely on the premarket regulatory submission angles which can't ultimately be met without preceding quality management system support.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 06-Feb-2024 11:18
From: Anonymous Member
Subject: Procedure Pack Producer Quality Agreement

This message was posted by a user wishing to remain anonymous

Dear Community,

We (Company A) are procuring a custom Procedure Pack from a US-based Procedure Pack Producer (PPP). The procedure pack will be OEM labelled by the PPP, shipped to Europe, consolidated with Company A's product (Class 2), and packaged in an outer shelf carton with Company A labeling. The PPP will be the legal manufacturer of the Procedure Pack and will have full responsibility for all regulatory approvals and PMS. The final consolidated product will be shipped to the US for distribution under Company A's 510(k).

Does anyone have any experience with a similar distribution chain and what regulatory challenges do you foresee?

In terms of a Supplier or Quality agreement between both parties, does anyone have a template they can share or what are the typical clauses that need to be captured?

Thanks in advance for your assistance.