Any Design Validation procedure comprises of the tests required to demonstrate the functions of the medical device as expected and it should meet the needs of the user. It incorporates inspection and analyses as part of validation in addition to testing.

Any given medical device includes the label, the instructions for use, the packaging, and everything inside your packaging. So you can say Validation includes all of it.

1) Diagnostic slide : In my opinion, since the slide is already present in the market and it will be used in Vitro, it falls under class 1 and so doesn’t require any clinical trials for that matter. Whether it is used for diagnosing the stem cells Bio-markers or something else, it can never be classified in any other category. So i guess FDA should be fine with it without it going any clinical trials.

2) Bone plate: From the video lectures what i have understood is, that a bone plate is classified as Class 2 material. And since its not a new innovation so it must be filed under 510(k). And there shouldn’t be any requirement for the clinical trials in case of an implantable bone plate as bone plates are always implanted. So it doesn’t make a difference whether its a bone plate or an implantable bone plate. But it would be best if the company can just call it a ‘bone plate’ instead of calling it an ‘implantable bone plate’. Because anything that sounds complicated can come in the radar of the class 3 according to FDA.

3)Antimicrobial suture: A suture is usually a class 2 material and needs a 510(k) filing but since this suture claims to have antimicrobial effect when used. So it will have to prove its safety and efficacy, thus will require a clinical trial. Because then it falls under Class 3 as it provides something extra from the usual sutures. But if its already there in the market, then 510(k) form should be good enough.

4) Ergonomic knee brace: A device like that which provides support to the knee cap doesn’t even require a Pre-market notification as it is a Class 1 device. So clinical trials is out of question.