Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Does anyone have any guidance or information on pre-DV. When and and why would you conduct Pre-DV? Do you know if there is an FDA guidance on the subject or what would be their expectation? If one was conducting pre-DV, would validated test methods be required?

I've done a fair bit of design and development over the last 25 years and haven't specifically heard the term "pre-DV".  That specific term doesn't exist in FDA's design control guidance document, design control regulation preamble, or the regulation itself.  It would be helpful if you can define precisely what your firm means by "pre-DV".

In the meantime, here are some FDA statements that may be helpful for you:

• "...it is occasionally necessary to produce a prototype device and have it evaluated by a physician who is an expert in the area of the device's intended use...One comment questioned whether design verification and validation can be conducted using prototypes or machine shop models...FDA regulations do not prohibit the shipment of prototypes for clinical or other studies...The final verification and validation...must include the testing of actual production devices under actual or simulated use conditions..." [emphasis added]

• "...Often, changes not reflected in the prototype are made in the device to facilitate the manufacturing process, and these may adversely affect device functioning and user interface characteristics. Proper testing of devices that are produced using the same methods and procedures as those to be used in routine production will prevent the distribution and subsequent recall of many unacceptable medical devices..."

• "...It may be reasonable to develop a rapid prototype to explore the feasibility of an idea or design approach, for example, prior to developing design input requirements. But manufacturers should avoid falling into the trap of equating the prototype design with a finished product design. Prototypes at this stage lack safety features and ancillary functions necessary for a finished product, and are developed under conditions which preclude adequate consideration of product variability due to manufacturing..."

• "...engineering sketches may be developed for prototyping purposes prior to development of production drawings. Evaluation of the prototype would typically culminate in a formal design review..."

• ...In some organizations, engineering essentially completes the design, tests an engineering prototype, and conducts a formal design review prior to turning the design over to manufacturing. In such cases, an additional review will be needed after the design has been validated using production devices..."

• "...the manufacturer must define the performance characteristics, safety and reliability requirements, environmental requirements and limitations, physical characteristics, applicable standards and regulatory requirements, and labeling and packaging requirements, among other things, and refine the design requirements as verification and validation results are established. For example, when designing a device, the manufacturer should conduct appropriate human factors studies, analyses, and tests from the early stages of the design process until that point in development at which the interfaces with the medical professional and the patient are fixed. The human interface includes both the hardware and software characteristics that affect device use, and good design is crucial to logical, straightforward, and safe device operation. The human factors methods used (for instance, task/function analyses, user studies, prototype tests, mock-up reviews, etc.) should ensure that the characteristics of the user population and operating environment are considered...."

• ISO TC/210 (author of ISO 13485:2016 with which FDA will soon "converge" its current design control regulation) Practical Guide: "...[design and development] reviews are conducted at strategic points in the design and development process. For example...review is used to assure that the outputs are adequate before prototypes are produced for simulated use testing or clinical evaluation..." [emphasis added]

• ISO TC/210: "...many of the verification activities help to provide confirmation that the overall output will meet the [requirement]. This might include simulated [testing] of prototypes..." [emphasis added]

• ISO TC/210: "...It is not always possible to determine the adequacy of product by building and testing prototypes or models produced in a laboratory setting..."

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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 12-Sep-2023 07:01
From: Anonymous Member
Subject: Pre-Design Verification

This message was posted by a user wishing to remain anonymous

Does anyone have any guidance or information on pre-DV. When and and why would you conduct Pre-DV? Do you know if there is an FDA guidance on the subject or what would be their expectation? If one was conducting pre-DV, would validated test methods be required?

Hello Antonymous,

I am assuming when you say 'pre-DV', you are referring to doing a mini-DV before exiting design freeze phase of your design control process before you have validated your process. To my knowledge, there is no FDA guidance on this. This is covered under 21 CFR 820.30 (f).

Pre-DV/mini-DV is a risk mitigation for companies to know that your units (representing final design) built on non-validated processes (lot release) meets your pre-defined requirements (i/p meets o/p) before you do a formal DV on devices made after your process is validated based on a statistically valid sample size. 

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[Shiven]
[Regulatory Affairs]
[San Francisco] [CA]
------------------------------

Original Message:
Sent: 12-Sep-2023 07:01
From: Anonymous Member
Subject: Pre-Design Verification

This message was posted by a user wishing to remain anonymous

Does anyone have any guidance or information on pre-DV. When and and why would you conduct Pre-DV? Do you know if there is an FDA guidance on the subject or what would be their expectation? If one was conducting pre-DV, would validated test methods be required?

I share the same uncertainty about the term 'pre-DV' as the other respondents. On the assumption that it is pre-Design Verification & Design Validation, and is either testing as part of the development of design outputs (e.g. DOE to assess different combinations on performance, or formative usability studies) or is testing taking place even earlier as part of concept development/feasibility studies... As both Kevin and Shiven have replied, I am not aware of any specific requirements within 21 CFR 820 or ISO 13485 that controls this specifically, but their intent and principles (spirit?) apply as per my points below...

What do you want to / intend to use the data (from the testing) for?

What decisions are going to be made based on the analysis of the data? T

hat should then help you answer how much control you want over the test samples and test methods. The less control, the more uncertainty and the less useful the data is further down the line.

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Ed Ball
Manager, Intelligence & Innovation
United Kingdom
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Original Message:
Sent: 12-Sep-2023 07:01
From: Anonymous Member
Subject: Pre-Design Verification

This message was posted by a user wishing to remain anonymous

Does anyone have any guidance or information on pre-DV. When and and why would you conduct Pre-DV? Do you know if there is an FDA guidance on the subject or what would be their expectation? If one was conducting pre-DV, would validated test methods be required?

This message was posted by a user wishing to remain anonymous

I was at a company where "pre-DV" meant running through the test protocols to make sure they were written correctly and could be executed smoothly. This was a prerequisite to approval of the protocols for use.

I was at another company where "pre-DV" meant basic safety testing  performed before beginning the usability and functional testing with human test subjects. This was meant to provide some assurance the equipment would not fall on or electrocute any of the volunteer subjects.

Original Message:
Sent: 13-Sep-2023 04:53
From: Edward Ball
Subject: Pre-Design Verification

I share the same uncertainty about the term 'pre-DV' as the other respondents. On the assumption that it is pre-Design Verification & Design Validation, and is either testing as part of the development of design outputs (e.g. DOE to assess different combinations on performance, or formative usability studies) or is testing taking place even earlier as part of concept development/feasibility studies... As both Kevin and Shiven have replied, I am not aware of any specific requirements within 21 CFR 820 or ISO 13485 that controls this specifically, but their intent and principles (spirit?) apply as per my points below...

What do you want to / intend to use the data (from the testing) for?

What decisions are going to be made based on the analysis of the data? T

hat should then help you answer how much control you want over the test samples and test methods. The less control, the more uncertainty and the less useful the data is further down the line.

------------------------------
Ed Ball
Manager, Intelligence & Innovation
United Kingdom

Original Message:
Sent: 12-Sep-2023 07:01
From: Anonymous Member
Subject: Pre-Design Verification

This message was posted by a user wishing to remain anonymous

Does anyone have any guidance or information on pre-DV. When and and why would you conduct Pre-DV? Do you know if there is an FDA guidance on the subject or what would be their expectation? If one was conducting pre-DV, would validated test methods be required?

Hi Anon,

In the drug delivery Combination Product area, I have seen this term used often.  There are no formal definitions, nor does the term or practice have any official status or guidance under the FDA or any regulatory scheme.

The term is usually applied to a defined set of tests done on a defined set of products to achieve experience and knowledge regarding the readiness of the project or product to enter into a formal Design Verification.  It can be a subset of DV tests (usually not stability), a subset of samples (usually, but not always finished products), not always a statistically sufficient sample size, etc. It could also, as you suggest, be done with non-validated TMs.  For some, it is a full "practice" Design verification, before all processes, parts, specifications, and/or documentation is completed/signed.

In other words, it is testing that you have defined to give you confidence and/or knowledge and is whatever you define it is in the protocol(s).

I hope that helps.

Good Luck

------------------------------
Lee Leichter RAC
President
Fort Denaud FL
United States
------------------------------

Original Message:
Sent: 12-Sep-2023 07:01
From: Anonymous Member
Subject: Pre-Design Verification

This message was posted by a user wishing to remain anonymous

Does anyone have any guidance or information on pre-DV. When and and why would you conduct Pre-DV? Do you know if there is an FDA guidance on the subject or what would be their expectation? If one was conducting pre-DV, would validated test methods be required?

This message was posted by a user wishing to remain anonymous

Thanks everyone for your feedback on this subject. To add some context to my original question, I've seen Pre-DV used in previous organizations as a mini-DV prior to executing the real thing to give you a level of assurance the formal DV will pass. Ideally, it would use validated test methods, particularly for novel or non-standard TM so that you have a level of confidence with the method and the results generated.

The reason I'm querying this is there is also a train of thought in my current organization (start-up), that the prototype/characterization testing that has been completed to date, is a pre-DV test which I'm strongly rejecting, as the objective of this characterization testing was to establish specifications/define a test methodology and was not performed using robust test methods nor a valid sampling plan (or close to it), sometimes just on a couple of samples.

Original Message:
Sent: 13-Sep-2023 07:51
From: Lee Leichter
Subject: Pre-Design Verification

Hi Anon,

In the drug delivery Combination Product area, I have seen this term used often.  There are no formal definitions, nor does the term or practice have any official status or guidance under the FDA or any regulatory scheme.

The term is usually applied to a defined set of tests done on a defined set of products to achieve experience and knowledge regarding the readiness of the project or product to enter into a formal Design Verification.  It can be a subset of DV tests (usually not stability), a subset of samples (usually, but not always finished products), not always a statistically sufficient sample size, etc. It could also, as you suggest, be done with non-validated TMs.  For some, it is a full "practice" Design verification, before all processes, parts, specifications, and/or documentation is completed/signed.

In other words, it is testing that you have defined to give you confidence and/or knowledge and is whatever you define it is in the protocol(s).

I hope that helps.

Good Luck

------------------------------
Lee Leichter RAC
President
Fort Denaud FL
United States

Original Message:
Sent: 12-Sep-2023 07:01
From: Anonymous Member
Subject: Pre-Design Verification

This message was posted by a user wishing to remain anonymous

Does anyone have any guidance or information on pre-DV. When and and why would you conduct Pre-DV? Do you know if there is an FDA guidance on the subject or what would be their expectation? If one was conducting pre-DV, would validated test methods be required?

This message was posted by a user wishing to remain anonymous

Pre-DV is feasibility testing. If you're not using it to support any submissions, there is no need to use validated test methods. Using validated methods can help you to identify issues earlier in the process, so you might want to do so. It is a business decision. If you are using the pre-DV to inform risk analyses or other documents you plan to submit, there could be questions about the soundness of your decisions if the test methods are unusual, but that would eventually be confirmed by the actual DV so probably not a big deal.

Original Message:
Sent: 12-Sep-2023 07:01
From: Anonymous Member
Subject: Pre-Design Verification

This message was posted by a user wishing to remain anonymous

Does anyone have any guidance or information on pre-DV. When and and why would you conduct Pre-DV? Do you know if there is an FDA guidance on the subject or what would be their expectation? If one was conducting pre-DV, would validated test methods be required?