Glossary
Selected key terms pertaining to medical device development are listed below with References.
Key Terms
There is currently 1 key term in this directory beginning with the letter #.
510(k) summary
a summary, submitted under section 513(i) of the act, of the safety and effectiveness information contained in a premarket notification submission upon which a determination of substantial equivalence can be based. Safety and effectiveness information refers to safety and effectiveness data and information supporting a finding of substantial equivalence, including all adverse safety and effectiveness information.
[FDA 21CFR807]
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.