Medical Device Accessory Responsibility

I

IZAKK

Registered
#1
#1
Hi All, I really enjoy this forum! I have a scenario that I would appreciate some guidance on.

Customer sells class 1 medical device, and a Supplier sells a class 1 medical device accessory (single-use and sterilized in packaging) that works with the Customer’s medical device.

Associated note: the Supplier designed the accessory, owns the design, and already sells the accessory to many different customers. They update the labeling to reflect customers' information as applicable to the specific customer's medical device.

The Customer wants to purchase the supplier’s accessory, have the supplier place the Customer's name and information on the label and packaging to market and sell for use with their medical device. There will be no indication or reference to the supplier information, the accessory will seem as though it is the Customers product entirely. Although, the label will indicate “manufactured for” on the label.

Question: Since the Customer did not design the accessory, and keeping in mind the accessory is sterile packaged, what from a regulation, documentation, and compliance standpoint does the Customer need to do in their system to approve and properly release the device? Examples:
  • Even though they did not design, do they need to identify user needs, input, outputs, (performance) verification, and validation activities specific to how the accessory will be used with their device?
  • Is a Risk plan, assessment, or report required? Or can a concise evaluation memo be used?
  • Any package performance testing required?
  • Whose UDI should be on the labeling? I would assume the Supplier to be the Device labeler and their UDI would apply but am unsure.
  • Is the Customer considered a Distributor or do they need to register and list as manufacturer?
  • Who handles complaints and is most responsible if device accessory fails?
  • Anything else I am missing?
Any help would be greatly appreciated!
 
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I

IZAKK

Registered
#2
#2
Hi all, just wondering if this question is in the correct location. Could someone let me know if I posted this correctly? This is my first time posting. Any help would be appreciated! Thanks!
 
Sidney Vianna

Sidney Vianna

Post Responsibly
Leader
Admin
#3
#3
IZAKK said:
Hi all, just wondering if this question is in the correct location. Could someone let me know if I posted this correctly? This is my first time posting. Any help would be appreciated! Thanks!
Click to expand...
I moved the thread and changed the title. Feel free to request it to be moved elsewhere and another better title description
 
Y

yodon

Leader
Super Moderator
#5
#5
Lack of a response is probably indicative of fears over giving regulatory advice and especially with limited information.

And count me in that group. But I have some questions that may at least trigger some discussion.

Can the device be used without the accessory?

Does the device risk file address use with the accessory?

And a couple of thoughts.

You say the accessory is delivered sterile so, yes, I would say there should be sterilization validation and sterile packaging validation.

If Customer's name goes on the labeling, they would, I believe, be considered the ones to receive and manage complaints.
 
I

IZAKK

Registered
#6
#6
yodon said:
Lack of a response is probably indicative of fears over giving regulatory advice and especially with limited information.

And count me in that group. But I have some questions that may at least trigger some discussion.

Can the device be used without the accessory?

Does the device risk file address use with the accessory?

And a couple of thoughts.

You say the accessory is delivered sterile so, yes, I would say there should be sterilization validation and sterile packaging validation.

If Customer's name goes on the labeling, they would, I believe, be considered the ones to receive and manage complaints.
Click to expand...
Hi, and thanks for the response! Please see my comments.

Can the device be used without the accessory? Device can be used without the accessory.

Does the device risk file address use with the accessory? Yes, it does.

And a couple of thoughts.

You say the accessory is delivered sterile so, yes, I would say there should be sterilization validation and sterile packaging validation.

The packaging is validated by the supplier and is sold that way. Do you think a certification of sterilization from the supplier would be acceptable or is having the actual reports on file necessary.

If Customer's name goes on the labeling, they would, I believe, be considered the ones to receive and manage complaints.

Thanks!
 
Y

yodon

Leader
Super Moderator
#7
#7
IZAKK said:
The packaging is validated by the supplier and is sold that way. Do you think a certification of sterilization from the supplier would be acceptable or is having the actual reports on file necessary.
Click to expand...
Possibly. Bear in mind that you are ultimately responsible FDA would be well within their rights to ask for the sterilization validation documentation. Do the due diligence to ensure that information is available and compliant.
 
I

IZAKK

Registered
#8
#8
yodon said:
Possibly. Bear in mind that you are ultimately responsible FDA would be well within their rights to ask for the sterilization validation documentation. Do the due diligence to ensure that information is available and compliant.
Click to expand...
I agree, and thanks for the feedback!
 
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