In my opinion, design validation is the first quality control parameter of a product that ensures that a product not only satisfies all the previously outlined requirements, but also the regulations of the industry. For example, when designing a project you might come up with unique requirements that are outside of the realm of what is currently on the market but it would still need to meet all the regulations that the other products on the market met.

1) A diagnostic microscope slide that determines the presence of certain stem cell markers.

In my opinion this would be under the CBER and would require a trial because it would be a “blood establishment product”.

2) An implantable bone plate

In my opinion this would be under the CDRH and be a class 2 and only require a 510(k). As part of the 510(k), it doesn’t need a trial but in my opinion a trial should be conducted.

3) An antimicrobial suture

Again, in my opinion this will be under the CDRH and be a class 2 and only require a 510(k). As part of the 510(k), it doesn’t need a trial but in my opinion a trail should be conducted.

4) An ergonomic knee brace

This is under the CDRH and is a class 1 so it is exempt from pre-market notification and doesn’t need a trial.