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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. 

For this requirement, the term "governmental regulatory approval process" applies to United States federal regulatory activities or equivalent regulatory processes outside of the US. There are several paths to regulatory approval, depending on the product being developed by the startup company. These are some examples:

  • Prescription drugs and biologics: Before a compound can be made available for clinical trials it must be approved by the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) through an Investigational New Drug (IND) application. A startup is eligible until the company submits an IND application.
  • Medical devices, including in-vitro diagnostics: A startup is eligible until it initiates a Premarket Submission process with the FDA, such as a Premarket Notification 510(k). Premarket Approval (PMA), a De Novo Classification Request, etc.
  • Over the counter (OTC) drugs: A startup is eligible until it submits an application or Over-the-Counter (OTC) Drug Review (OTC drug monograph) to the FDA.

ACCME encourages providers to become more familiar with the overall FDA regulatory design for each class of product, as the above is only a brief summary and may not apply in every case. Resources to better understand each of these market entry processes can be found at www.FDA.gov.

For more information, please see the following resources:

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