Design Validation means exactly that, verifying that the right device was designed. For example, if a user wanted an ointment to heal burn scars but the final product only caused hair to grow on the scar instead then this product would fail design validation. In these respects, don’t all medical devices need clinical evaluation for their design validation? Then determining whether a device needs a clinical trial would mean identifying if it is really, truly a medical device.

1. No. Since stems cell marker presence is more of an accompaniment to a medical decision, they have little risk on the patient and therefore such a device would not need clinical trials. This is nothing like a Pap smear or even a molecular test for cancer biomarkers.

2. Yes. Anything implantable posses a high risk to the patient’s health and confirmatory clinical trials as to its safety and effectiveness would be required.

3. Maybe. Sutures are a class II device and would only need a 510(k) as long as it is a doppelganger of any existing sutures. Also the antimicrobial part must not seem like a concern and would have to be shown as safe and effective in its use on any previously approved devices.

4. No. This knee brace would be considered a medical support stocking and could be exempt from any clinical trials. Regardless, clinical trials are not needed for ergonomic chairs and keyboards, then why have them for ergonomic knee braces?