GLOSSARY

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O

Term Definition
OAI (Official Action Indicated)

A classification for an FDA audit that indicates that action is required by the inventor or company in order to seek approval for a device.

Observational Studies

Studies that make conclusions about the efficacy of a treatment or device on a group of subjects where the assignment of subjects into the treated versus control groups is outside the control of the investigator.

OCP (Office of Combination Products)

Office of Combination Products; the section of the FDA that reviews medical technology that is a combination of drugs and device or drugs and biologics to determine which center of the FDA will regulate it.

Off-Label use

The use of a treatment for conditions other than those approved by the FDA.

Office action

A document issued by the USPTO that outlines objections or necessary changes to an application or claim due to finding prior art.

Operating profit

The difference between income and the expense incurred during operations.

OpEx (operating expenses)

Costs considered not to be manufacturing costs, including R&D, sales staff, general and administrative functions, and non-production facilities costs.

Opportunity cost

The opportunity forgone by choosing a different opportunity.

Option pool

The total number of stock options available for a company to grant, typically to employees.

OTC (Over the Counter)

Drugs or devices that are sold directly to the end consumer.

OTL (office of technology licensing)

The office within a university that manages its IP assets.

OUS (Outside United States)

Refers to clinical trials that are performed outside the US. Used in reference to obtaining regulatory approval.

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