Glossary
Selected key terms pertaining to medical device development are listed below with References.
Key Terms
There are currently 6 key terms in this directory beginning with the letter O.
OEM product
a product purchased from an original equipment manufacturer with the intention of being made available on the market by the purchasing organization which does not own the product design
Note: In this scenario, the original equipment manufacturer owns the product design and is considered a supplier to the purchasing organization that makes the product available on the market.
Note: In this scenario, the original equipment manufacturer owns the product design and is considered a supplier to the purchasing organization that makes the product available on the market.
off-label use
use of a health product in a manner that is not approved by the regulatory authority with jurisdiction at the location of use
operating principle
The mode of operation or mechanism of action through which a device fulfills (or achieves) its intended use
Note: An example of a change in operating principle would be using a new algorithm to compress images in a picture archiving and communications system. For an IVD, an example would be a change from immunofluorescence to ELISA.
Note: An example of a change in operating principle would be using a new algorithm to compress images in a picture archiving and communications system. For an IVD, an example would be a change from immunofluorescence to ELISA.
[FDA guidance: Deciding When to Submit...(2014)]
output
result of a process
Note: Whether an output of the organization is a product or a service depends on the preponderance of the characteristics involved, e.g. a painting for sale in a gallery is a product whereas supply of a commissioned painting is a service, a hamburger bought in a retail store is a product whereas receiving an order and serving a hamburger ordered in a restaurant is part of a service.
Note: Whether an output of the organization is a product or a service depends on the preponderance of the characteristics involved, e.g. a painting for sale in a gallery is a product whereas supply of a commissioned painting is a service, a hamburger bought in a retail store is a product whereas receiving an order and serving a hamburger ordered in a restaurant is part of a service.
[ISO 9000:2015]
overhead
the ongoing business expenses not directly attributed to creating a product or service
Note: Overhead is important for budgeting purposes but also for determining how much a company must charge for its products or services to make a profit. In short, overhead is any expense incurred to support the business while not being directly related to a specific product or service.
Note: Overhead is important for budgeting purposes but also for determining how much a company must charge for its products or services to make a profit. In short, overhead is any expense incurred to support the business while not being directly related to a specific product or service.
[Investopedia]
Medical device developers are strongly encouraged to consult the listed reference for each key term to fully understand the context behind the definition and its intended application.
Definitions from the FDA Code of Federal Regulation (CFR) are listed without dates and are accurate through December 2020. Consult the listed FDA reference (online) to confirm the latest definition.