When is a company that is developing its first product considered to be an ineligible company?
As described in the Standards’ section on eligibility, a biomedical startup is considered an ineligible company if it has begun a governmental regulatory approval process.
- Drugs: The ACCME considers the submission of the Investigational New Drug Application (IND), which must be approved before clinical trials can begin, as the point of entry into the government regulatory approval process. This graphic published on the FDA website shows where in the drug development cycle the IND is submitted. Once a company makes this submission, it would be considered an ineligible company.
- Medical devices: When a company initiates a premarket approval (PMA) process submission, as described on the FDA website here, it would then be considered an ineligible company.