Hi @wonbum-sohn

I recall from taking Professor Simon's other course BME 684 where he mentioned standards of verification and validation which are essentially protocols that must be followed when creating a medical device. These two standards are different where verification refers to testing individual components of the device as the development of the device is moving along (checking to see whether the outputs of the device match the inputs) while validation refers to the overall testing of the product and verifying whether the product meets the customers' needs and whether device was built and functions as intended. In terms of the FDA, yes the standard for verification and validation need to be approved by the FDA in order to deem the testing valid. If these standards are not approved by the FDA then the medical device itself may not be FDA approved and could have malfunctions in the device that could end up harming the user. Considering that the FDA has a hand in almost every aspect of the medical device development process, do you think that the FDA has too much power in this industry and is too strict or do you think that the country/world could benefit of even more stringent guidelines and requirements?

I found further information regarding this topic through this presentation that was made by an FDA officer that can be found here:

https://www.fda.gov/media/94074/download

Hi! Verification and validation tests are super important for making sure that devices are manufactured correctly. I definitely think that these procedures and standards need to be indirectly approved by the FDA, in the sense that the end result of the device complies with the FDA’s regulations. In other words, companies will perform several validation/verification tests that they deem fit for proving that their devices are both manufactured and functioning properly. If those tests are chosen/performed correctly and results show the device is safe for customer use, then the device will most likely be FDA approved, indicating that the tests were appropriate (and approved). The FDA uploaded a guide for industry on general practices in design validation which provides recommendations on how to perform these tests and document methods, results, etc. My takeaway from this document is that the standard or protocol itself does not need to be FDA approved, but the success of their results and the clarity of chosen procedures and results will lead to the overall device being FDA approved. 

@ag2265 made a good point above. I definitely think that the FDA is pretty strict, but with good cause. Without strict guidelines, industries would be able to market any product, safe or unsafe. It’s hard to say whether or not the world would benefit from even more stringent regulations because there are always exceptions. For example, the COVID-19 vaccine was released more rapidly than other vaccines being developed for purposes other than a pandemic. With stricter regulations, the quick release of the much needed vaccine probably wouldn’t have been so easy. What are your thoughts on Emergency Use Authorization in the FDA?

As mentioned by my peers above, while the validation and verification protocols shouldn't directly be approved by the FDA (as in, not really required), the results of these tests conducted should result in the product/device being developed meet the regulations set forth for that device by the FDA. The FDA is strict and for a good reason. It would be horrible if there were no regulations and entrepreneurs looking to make a quick buck advertised and released something to the public that not only did not deliver what was promised, but also negatively impacted the community. 

To answer the question above, I personally believe that the Emergency Use Authorization is a good tool in the FDA. In the case of COVID-19, I believe that having access to these vaccines prevented a large number of deaths that would have occurred due to exposure. I think in situations like these, the FDA had to think hard about if the pros of the new product outweighed the potential cons. Had the vaccine been stuck behind strict regulations without exceptions, who knows how many more lives the virus would have claimed. But at the same time, the complete long term effects of the vaccine were not known. Historically, we are all now essentially one big case study, and it will be interesting (and maybe at some point a little scary), to see how this all plays out in the future and if there will be an effect that was not considered (if any).

The FDA should have some indirect impact on verification and validation tests. Ideally, these would be guidelines for companies should follow, but should not be strict standards. Regulatory requirements already have a strong impact on medical devices, especially smaller startups which may be trying to bring a novel device to the market. This issue may not be present for larger companies, that tend to avoid the lengthy process of bringing novel devices to the market due to the costly, lengthy, and challenging regulatory issues it may present. Regulatory compliance already costs smaller companies a fortune to design and develop their devices to meet the current FDA standards. Enforcing these standards within verification and validation could make it even more costly for the company, which can then be reflected in cost to the consumer. This idea is a double-edged sword. Leniency from regulatory agencies has led to unsafe devices in the past, so there should be a defined limit. However, the question should be whether all devices would require FDA regulation for verification and validation. If this were to go into effect, are there categories of devices that should be exempt in some way?

I agree with @gdecarvalho22 above that the FDA indirectly approves the tests as long as the final design and design process shows to comply with FDA standards. If the test parameters are not within what the company claims for either test, then making false claims is illegal. If the company is following all other rules and regulations, but the Verification and Validation test procedures are bad, then they will simply fail the test or get insignificant results.

One condition when the FDA approves verification and validation procedures and standards is for clinical trials whenever animal or human subjects are used. Other than that, the FDA won't review your testing procedures to check if you're using the scientific method. Their job is to evaluate just the product's safety and effectiveness.

Based on the replies on this thread, while the FDA doesn't directly approve the specific procedures for verification and validation, it certainly plays a critical role in ensuring that the end results meet safety and efficacy standards. The FDA’s oversight ensures that medical devices are safe and effective before they reach the market, which is essential for public health. I agree with the points that there needs to be a balance between having enough regulation to ensure safety without making the process so costly and restrictive that it stifles innovation, especially for smaller companies. I also think the discussion around Emergency use authorization (EUA) raises an interesting point about the need for flexibility in urgent situations, like the COVID-19 vaccine, where the benefits of rapid approval outweighed the potential risks.

In the medical device world, procedures and standards for verification and validation (V&V) tests usually don’t need to be directly approved by the FDA before they’re used. However, the FDA definitely expects that your V&V methods are based on solid, recognized standards—like ISO 13485 for quality systems or ISO 14971 for risk management—and that everything is well-documented, traceable, and carefully followed. When you submit a device for FDA review, whether it’s through a 510(k) or PMA, the agency will take a close look at both your test results and how you conducted the testing. If you used recognized industry standards (like ISO, ASTM, or IEC), that can make the review go more smoothly because the FDA is already familiar with those methods. If you’re using custom procedures, you’ll need to clearly explain why they make sense scientifically and why they’re strong enough to prove the device is safe and effective. So, even though formal "pre-approval" of your V&V plans isn’t required, they still have to be rock-solid when the FDA starts reviewing your submission.

The guidance states that the methods used for verification and validation do not need FDA approval before use. However, it says that the methods must be consistent with the FDA's design control system, which includes such elements as planning, verification, validation, and maintenance of a complete Design History File, which details how testing is developed and reviewed. The current guidance contains a statement that suggests the FDA is more focused on design control documentation than on pre-approval of test methods.

In the project, the PDCA cycle uses verification and validation (V&V) while performing testing at different stages. Verification checks whether design outputs match design inputs. Validation examines whether the device fulfills user needs through performance of testing. These procedures and reports need to be followed in a prescribed manner, so companies can be expected to be capable of ensuring quality controls on their own and not require FDA pre-approval, especially as designs change.

This system can be compared to training for a professional sports league. Teams are not required to submit their daily practice plans for approval, but when game day arrives, referees and officials evaluate performance based on established rules. If a team ignored proper training, it would show in poor performance and penalties. In the same way, weak verification and validation practices become obvious during FDA review.

At the same time, the FDA still plays a major role through audits and submission reviews. During 510(k) or PMA evaluations, reviewers examine the Design History File, verification reports, and validation data to determine if the testing approach was appropriate. If methods are poorly justified or incomplete, the submission may be delayed or rejected. In this way, approval happens indirectly through regulatory review rather than through early authorization.

Thus, the system gives manufacturers a motivation to make a reliable, validated testing program that finds the optimum balance between innovation and consumer safety. An open question is whether at the time of the V&V plan review, for high-risk devices with clinical studies, earlier review by the FDA is needed for improved patient safety or whether review after submission suffices.

Verification checks that the inputs equals the output, meeting design specifications, while validation checks that the inputs equal the user needs or intended use, satisfying the acceptance criteria. All of these testings are done by the project manager and project team, not the FDA. With many medical devices being made, the FDA does not directly approve verification and validation tests. They are not required to do so. The responsibility of these tests fall into the project team’s hands. For verification, they are responsible for making up a test, doing the test, checking the results, and seeing if the output passes the test or not. They create verification protocols and use different protocols and standards like 21CFR820.3(f) with design input and 21CFR820.3(y) for specifications. There is also 21CFR820.3(aa) with verification where it is the confirmation by examination and provision of objective evidence that specified requirements have been fulfilled and if the device is built correctly with the verification protocol and design verification report. In addition, ISO 13495:2016 Section 7.3.6 creates verification plans that have methods, acceptance criteria, statistical technique, and sample size rationale. It ensures that the output meets input requirements, keeps records of the results, as well as conclusions and actions.

Design validation follows the FDA standard and documents as well. There is 21CFR820.3(z) with design and process validation to establish by objective evidence that the device specifications conform with user needs and intended use, while the process produces a result or product meeting its predetermined specifications. It also follows standard ISO 13485:2016 Section 7.3.7 to create validation plans with methods, acceptance criteria, statistical techniques, and sample size rationale. It creates the design validation report that includes the result, conclusion, action, clinical studies, performance evaluation, and that the product is meeting the intended user requirements. Again, verification and validation tests are not directly approved by the FDA and the project development team is in charge and responsible for creating and implementing various protocols for the safety and efficacy of their products. Overall, all of these tests should adhere to regulatory compliance. If verification and validation tests are not being met or are consistently failing, the FDA has full authority to conduct an inspection to evaluate the process validation, provide corrective action, or give penalties for any product deemed unsafe based on test results and data.