TS03 Inc Trust Units TSTIF

Positive FDA Regulation Changes

[echo2]

In addition to the FDA regulation change that, as of today, requires that any new or modified scope included in the Government's published list - including duodenscopses and other complex scopes - as noted previously, the FDA will soon (before the end of 2017) modify rules and regulations such that applicants for medical devices will no longer need to have FDA on-site inspections as part of their approval applications. They will officially be accepting clinical and study data from the applicant as long as it meets rigorous scientific study standards, of course. This will reduce the burden on companies like TSO3 as it pursues 510k approval for the smaller 80L sterilization unit and pass-through VP4 and speed the approval process. It should also mean that scope manufacturers will be able to obtain and present data produced by TSO3's US and Canadian facilities without requiring specific FDA inspections of the testing and data production or of the clinical patient use of the scope. In other words, or so I would hope, TSO3's testing facilities or a hospital (or GI Unit) such as one of the Strategic Partners, working with TSO3 to validate the clinical use of their sterilizers will not have the burden of having to wait on FDA inspections to proceed with producing and submittig scientifc data that validates TSO3's VP4 or other low temperature sterilization units.

A small step, but a positive one!

https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201704&RIN=0910-AG48