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21CFR1002.3

§ 1002.3 Notification to user of performance and technical data.

Regulation Text

The Director and Deputy Director of the Center for Devices and Radiological Health, as authorized under delegated authority, may require a manufacturer of a radiation emitting electronic product to provide to the ultimate purchaser, at the time of original purchase, such performance data and other technical data related to safety of the product as the Director or Deputy Director finds necessary.

Authority

21 U.S.C. 352,360,360i,360j,360hh-360ss,371,374.

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Related Guidelines (1)

21CFR1002.3 — § 1002.3 Notification to user of performance and technical data. | CFR Explorer | BioRegHub