My 22 year old son is also an investor in Sensera.He made a...

My 22 year old son is also an investor in Sensera.
He made a somewhat flippant, but nonetheless obvious and re-assuring statement to me today.
"Dad, if they changed from Sensera's sensor to another manufacturer's sensor they would have to start the whole FDA process again wouldn't they ... there is now way NanoDX would want to do that ".

Putting aside any other protections Sensera have in place, it would not make any commercial sense for NanoDiagnostics to start the whole FDA process over again. Remember submitted test results to the FDA need to have been generated from commercially manufactured devices ( ie. not test devices etc. ).

It also affords some protection into the future, as not only would NanoDiagnostics need to develop new sensors with a new supplier while avoiding infringing any of the patents issued by the DoD for which Sensera has exclusive rights , but they would also need to undergo the entire testing regime again, and re-submit to the FDA, with the risks that entails.

From the FDA website :

Medical devices undergo frequent modifications to their design and materials due to many things; changes in the supply chain, continuous process improvement, or to keep pace with technological innovations that can improve how these devices work in a clinical setting. Major modifications to the device likely require premarket review by the FDA, while minor changes likely do not.

A premarket notification (510(k)) is required when a legally marketed device subject to 510(k) requirements is significantly changed or modified in design, components, method of manufacture, or intended use. Significant changes or modifications are those that could significantly affect the safety or effectiveness of the device, or major changes or modifications in the intended use of the device (21 CFR 807.81(a)(3)).

Examples of modifications that may require a new 510(k) include, but are not limited to, the following:
- Change to indicate compatibility with a type of device, component, or accessory that was not indicated as compatible with the previously cleared device
- Changes in device design
- A change in material type, formulation or chemical composition
- Changes in the antibody, detection reagents, critical reaction components or conjugates for in vitro diagnostic (IVD) devices

There are no provisions for a 510(k) amendment or supplement to the existing 510(k).If it is determined the modification is not covered by the current 510(k) a new 510(k) must be submitted.

IMO, changing the sensor which is a critical component would require re-submission.

And remember from the half yearly

The SARS-CoV-2 sensor developed in conjunction with NanoDx has progressed through theR&D phase and the final product is now in the hands of NanoDx.

GLTAH