IVD Device Design Change

Hello,

Our company currently has a Class III IVD device in review with the FDA. While we wait for an approval, we are starting design changes to be ready for a supplement submission. Our product development team has decided to put in a design change request but will handle the project as if it's a new product. Therefore it will have its on DFH, DMR, and DHR. This seems odd to me, I've never seen it done this way, doesn't mean it's wrong just curious if anyone else has experiences this and if it was a good or bad road to go down.

Thanks for any advice!

If your PMA is still awaiting approval, have you considered submitting an amendment to your PMA application?

I've only ever seen design changes carried out through revision of existing documentation, so it's strange that they want to take this approach. Not that's it's wrong, just an unusual approach in my experience.

It is not common to handle design changes as a new product with its own DHF, DMR, and DHR. It is not wrong, as long as the changes are properly documented and comply with the regulatory requirements.

According to the FDA's Quality System Regulation, the DHF should describe the design history, and it may not be necessary to maintain a record of every step in the design phase, although the "entire history" should be apparent from the document (61 FR 52602 (V)(A)(ii)(18)).

Orca1 said:

It is not common to handle design changes as a new product with its own DHF, DMR, and DHR. It is not wrong, as long as the changes are properly documented and comply with the regulatory requirements.

According to the FDA's Quality System Regulation, the DHF should describe the design history, and it may not be necessary to maintain a record of every step in the design phase, although the "entire history" should be apparent from the document (61 FR 52602 (V)(A)(ii)(18)).

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What are some reasonable approaches to introduce a new size or shape of an existing class III product? (New design input for the size). Is this considered a change or a new product with new DHF? If a change, what’s the best way to document the change?

Mkm1989 said:

What are some reasonable approaches to introduce a new size or shape of an existing class III product? (New design input for the size). Is this considered a change or a new product with new DHF? If a change, what’s the best way to document the change?

Click to expand...

Introducing a new size or shape of an existing Class III product can be considered a design change rather than a new product, provided the change does not significantly affect the safety or effectiveness of the device.

Here are some reasonable actions:
- Document the Design Change
- Perform Risk Analysis
- Verification and Validation
- Update Design History File (DHF)
- Update Device Master Record (DMR)

Orca1 said:

Introducing a new size or shape of an existing Class III product can be considered a design change rather than a new product, provided the change does not significantly affect the safety or effectiveness of the device.

Here are some reasonable actions:
- Document the Design Change
- Perform Risk Analysis
- Verification and Validation
- Update Design History File (DHF)
- Update Device Master Record (DMR)

Click to expand...

Thank you!!
Can you be more specific about the “update DHF”? Do I need a full Design & development plan as it it were a new product (add the new size to the user input and release the full set of requirements documents) or just make an appendix listing the new requirements?Similarly - delta documentation for DI/DO?

Mkm1989 said:

Thank you!!
Can you be more specific about the “update DHF”? Do I need a full Design & development plan as it it were a new product (add the new size to the user input and release the full set of requirements documents) or just make an appendix listing the new requirements?Similarly - delta documentation for DI/DO?

Click to expand...

Updating the DHF for a design change such as introducing a new size or shape of an existing Class III product does not necessarily require a full Design and Development Plan as if it were a new product. But it does require thorough documentation of the design change and its impact on the device's safety and effectiveness.

These are some logical steps for updating DHF for this purpose:

Document the Design Change-
Document the design change in detail, including the rationale for the change, the expected impact on the device's safety and effectiveness, and any necessary updates to design inputs and outputs. This could be done as an appendix or addendum to the existing DHF, or as a separate document that is referenced in the DHF.

Update DI/DO-
Update the design inputs to include the new size or shape, and update the design outputs to reflect the modified device specifications. This could be done as a delta documentation, which is a document that only includes the changes made to the design inputs/outputs.

Risk Analysis-
Document the risk analysis conducted for the design change, including any new or increased risks identified and how they will be mitigated.

Verification and Validation-
Document the verification and validation activities performed to ensure that the design outputs meet the design input requirements. This includes the results of any testing performed on the modified device.

Design Review-
Document the design review conducted at appropriate stages of the device's design development. This includes the results of the review, the date of the review, and the individuals performing the review.

Design Transfer-
Document the process of transferring the design change into production specifications.

Design Changes-
Document the procedures for the identification, documentation, validation or verification, review, and approval of design changes before their implementation.

The DHF should contain or reference all records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of the QSR.

mflick22 said:

Hello,

Our company currently has a Class III IVD device in review with the FDA. While we wait for an approval, we are starting design changes to be ready for a supplement submission. Our product development team has decided to put in a design change request but will handle the project as if it's a new product. Therefore it will have its on DFH, DMR, and DHR. This seems odd to me, I've never seen it done this way, doesn't mean it's wrong just curious if anyone else has experiences this and if it was a good or bad road to go down.

Thanks for any advice!

Click to expand...

In my experience of over 15 years, I have seen companies treat significant design changes as separate projects, especially when dealing with Class III medical devices and awaiting FDA approval. However, it's debatable if someone should do a completely separate Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR) or not. In this situation, since you already have the product under FDA’s review, it's wise to do the changes as a separate project. But, there are certain considerations to make:

• You should be accustomed to managing design changes in such a way that you do not undertake a lot of redundant documentation work and are able to leverage what’s already done. For this one should be well versed with the principles of medical device design and development. Here’s an overview guide - Medical Device Design and Development Guide.
• Clear traceability and accountability throughout the change process should be maintained.
• Assess the impact of the change on the device's safety, efficacy, and regulatory status.
• Conduct comprehensive risk assessments, usability studies, and verification and validation testing (as applicable) to ensure that the modified device meets all regulatory requirements and customer expectations.
• Ensure effective project management.

If you are able to take the aforementioned considerations into account, this will be a well balanced approach between the speed of innovation and compliance with regulation.