If a company is developing its first product, at what point does it become an ineligible company?

A biomedical startup company is considered to be ineligible if it has begun a “government regulatory approval process”.  The Standards’ section on eligibility explains that the point of entry into this process to be the actual submission of the Investigational New Drug Application (IND). This must be approved before clinical trials begin.  Once a company submits the IND, it would become an ineligible company.  For medical devices, this would be when a company submits a premarket approval (PMA).


Weekly Compliance Tip

What constitutes “non-clinical” education?  

Some good examples of non-clinical education are…

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