necessary

(5) (A) In requesting additional information with respect to an application under this section, the Secretary shall consider the least burdensome appropriate means necessary to demonstrate a reasonable assurance of device safety and effectiveness. (B) 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. (C) For purposes of this paragraph, the Secretary shall consider the role of postmarket information in determining the least burdensome means of demonstrating a reasonable assurance of device safety and effectiveness. (D) Nothing in this paragraph alters the standards for premarket approval of a device.

Source

21 USC § 360e(c)(5)


Scoping language

For purposes of this paragraph
Is this correct? or