necessary
Defined in 2 places of the United States Code.
For purposes of clause (i), the term “necessary” means the minimum required information that would support a determination of substantial equivalence between a new device and a predicate device.
Source
- 2012–present21 U.S.C. § 360CFood and Drugs · Classification of devices intended for human use · for purposes of this section
For purposes of clause (ii), the term “necessary” means the minimum required information that would support a determination by the Secretary that an application provides reasonable assurance of the effectiveness of the device.
Source
- 2012–present21 U.S.C. § 360CFood and Drugs · Classification of devices intended for human use · for purposes of this section
For purposes of subparagraph (A), the term “necessary” means the minimum required information that would support a determination by the Secretary that an application provides a reasonable assurance of the safety and effectiveness of the device.
Source
- 2016–present21 U.S.C. § 360EFood and Drugs · Premarket approval · under this section