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Summary of legislation _____________________________________________ __
Records and Reports on Devices Sec 519
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action advisory committee application for premarket appropriate class III device classiﬁcation panel classiﬁed into class Conference Report Cosmetic Act date of enactment Debate on Conference device into class devices intended enacted law establish exemption export Federal Food Federal Register ﬁnal ﬁndings ﬁnds ﬁrst House amendment House Committee Report House Floor Debate House Passed Bill implanted informal hearing informed consent inserting intended for human intrauterine devices introduced or delivered investigational judicial review labeling manufacturing practices medical devices ment notiﬁcation pacemakers paragraph person petition premarket approval prescribed promulgation proposed legislation proposed regulation provide reasonable assurance public health pursuant qualiﬁed reclassiﬁcation recommendation Report on Sec requirements respect revoking risk of illness safety and effectiveness scientiﬁc review Secretary determines section 513 Senate Committee Report Senate Floor Debate Senate Passed Bill speciﬁc specific legislative history submitted subparagraph subsection substantial testing tion trade secret United States Code