Design Verification & Validation vs Clinical & Pre-Clinical Trials - Introduction to Design Controls

RE: Design Verification & Validation vs Clinical & Pre-Clinical Trials

VKeithley — Sat, 08 Apr 2023 00:06:34 +0000

Devices such as a colostomy bag wouldn’t require a clinical trial and would suffice with validation and verification. This would not require a clinical trial because they do not pose a risk to the patient. This would be considered a low-risk device as it is not invasive.

RE: Design Verification & Validation vs Clinical & Pre-Clinical Trials

bpadgett@msm.edu — Sat, 11 Mar 2023 03:24:48 +0000

The Design and Development phase typically follows a Project Planning phase. According to the FDA, design verification is confirmation by examination and provision of evidence that requirements are fulfilled. Pre-clinical’s role in a new technology is to journey with the design and development phase to assure the product is fully dependent on itself. At the completion of project planning, innovators will know what is required to move from prototype to product. The meat of the job is superbly completing the design tasks, and ensuring that the device is ready for safe and effective customer use.

RE: Design Verification & Validation vs Clinical & Pre-Clinical Trials

mj386 — Wed, 14 Dec 2022 14:53:58 +0000

I think that devices that aren't going to be invasive to the user, Design Verification and Validation would be enough. I would say for Clinical Trials are unavoidable though they would be implemented for clarification. Such devices like blood pressure machines, compression socks, and thermometers would fall into this category.

RE: Design Verification & Validation vs Clinical & Pre-Clinical Trials

mmodi — Sun, 13 Nov 2022 20:16:54 +0000

I believe only conducting verification and validation studies is acceptable for a class I medical device or a class II medical device that is substantially equivalent to an existing product and requires just a 510(k) without pre-clinical and clinical trials. I am under the impression that any product that can pose moderate risk such as a diagnostic to detect diseases or guide treatment decisions as well as medical devices that are a combination product and require specific drug dosing, as per the examples in question from this thread, would require clinical trials in order to obtain premarket approval. Although there may be evidence of an existing use case, the manufacturers must still demonstrate their application/technology is similar, safe and effective, and has clearly indications for use which would require pre-clinical and/or clinical studies.

RE: Design Verification & Validation vs Clinical & Pre-Clinical Trials

Atharva — Sat, 05 Nov 2022 15:05:48 +0000

None of class 1 and even many class2 devices are exempted from clinical or preclinical studies, although they require design controls and other specifications. Since they do not directly react with the tissues diffusing chemicals or modifying the structure/mechanism, they usually are safe to use. Examples- Wheelchairs, Pulse oximeters

RE: Design Verification & Validation vs Clinical & Pre-Clinical Trials

Pedro F. — Mon, 09 Nov 2020 01:25:02 +0000

As pointed out by Dr. Simon if a medical device is a component and not directly used by the patient then the user needs and the specifications are essentially the same thing and design validation is not necessary for that product. This kind of confused me because I thought about diagnostic or prognostic testing; this is something that is not utilized by the patient, but is instead used by the physician providing care for the patient and any diagnostic test needs validations and verification studies even if they have 510k clearance and there is something similar in the market already. Could someone perhaps shine some light on this issue? Maybe I misunderstood the question?

I agree with them not needed clinical trials since they are not directly used on the patient, but do think they need long validation studies and correlation studies with already existing devices.

RE: Design Verification & Validation vs Clinical & Pre-Clinical Trials

Dkonara921 — Sun, 11 Nov 2018 21:38:16 +0000

The purpose behind pre-clinical and clinical trials is to determine how a product or service performs on a group of test subjects. Without clinical trials, there will be no way to determine the efficacy of the product or if the desired result is reproducible and causes arm to some patients. Products and services that do not cause harm to patients( e.g. thermometer) do require clinical trials to determine the efficacy of the product. This would only require Design Verification and Validation since you are trying to ensure that the instrument works. You want to make sure that there is no internal/external problem with the thermometer so that it will work in every case that it is relied upon.

RE: Design Verification & Validation vs Clinical & Pre-Clinical Trials

mb698 — Wed, 07 Nov 2018 16:44:02 +0000

Glove liners or under gloves are worn with patient examination or surgeon’s gloves which are made of material such as cotton to prevent the medical glove from contacting the user’s hand or may be made of the material that are resistant to cutting or puncture. Medical devices such as crutch which is used as a mobility aid that transfers weight from the legs to the upper body. It is often used by people who cannot use their legs to support their weight.

RE: Design Verification & Validation vs Clinical & Pre-Clinical Trials

Fp55 — Mon, 05 Nov 2018 22:06:22 +0000

If there is sufficient evidence already available for a similar device, V&V will only be necessary to make sure that the device meets the user needs (validation) and that the device functions as it should (verification). However, sometimes the results from clinical trials may be necessary for design verification. In this case it would be helpful to keep in mind how a certain user need will be met when the user needs are created. With proper documentation and planning, the devices that have been mentioned should not require clinical trials.

RE: Design Verification & Validation vs Clinical & Pre-Clinical Trials

nitinhebbar — Sun, 12 Nov 2017 23:31:04 +0000

Device like thermometer, gauze piece, micropores are used outside the body. Only verification and validation is sufficient for these devices and clinical/preclinical trials are not needed. These devices are low risk devices which does not harm patients.