118 STAT. 575 PUBLIC LAW 108–214—APR. 1, 2004 (E) in paragraph (6)(B)(iv)— (i) by inserting ‘‘(I)’’ after ‘‘(iv)’’; and (ii) by adding at the end the following: ‘‘(II) If, during the two year period following clearance under subparagraph (A), the Secretary determines that the device establishment is substantially not in compliance with this Act, the Secretary may, after notice and a written response, notify the establishment that the eligibility of the establishment for the inspections by accredited persons has been suspended.’’; (F) in paragraph (6)(C)(ii), by striking ‘‘in accordance with section 510(h), or has not during such period been inspected pursuant to section 510(i), as applicable’’; (G) in paragraph (10)(B)(iii), by striking ‘‘a reporting’’ and inserting ‘‘a report’’; and (H) in paragraph (12)— (i) by striking subparagraph (A) and inserting the following: ‘‘(A) the number of inspections conducted by accredited persons pursuant to this subsection and the number of inspec tions conducted by Federal employees pursuant to section 510(h) and of device establishments required to register under section 510(i);’’; and (ii) in subparagraph (E), by striking ‘‘obtained by the Secretary’’ and all that follows and inserting ‘‘obtained by the Secretary pursuant to inspections con ducted by Federal employees;’’. (2) OTHER CORRECTIONS.— (A) PROHIBITED ACTS.—Section 301(gg) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(gg)), as amended by section 201(d) of Public Law 107–250 (116 Stat. 1609), is amended to read as follows: ‘‘(gg) The knowing failure to comply with paragraph (7)(E) of section 704(g); the knowing inclusion by a person accredited under paragraph (2) of such section of false information in an inspection report under paragraph (7)(A) of such section; or the knowing failure of such a person to include material facts in such a report.’’. (B) ELECTRONIC LABELING.—Section 502(f) of the Fed eral Food, Drug, and Cosmetic Act (21 U.S.C. 352(f)), as amended by section 206 of Public Law 107–250 (116 Stat. 1613), is amended, in the last sentence— (i) by inserting ‘‘or by a health care professional and required labeling for in vitro diagnostic devices intended for use by health care professionals or in blood establishments’’ after ‘‘in health care facilities’’; (ii) by inserting a comma after ‘‘means’’; (iii) by striking ‘‘requirements of law and, that’’ and inserting ‘‘requirements of law, and that’’; (iv) by striking ‘‘the manufacturer affords health care facilities the opportunity’’ and inserting ‘‘the manufacturer affords such users the opportunity’’; and (v) by striking ‘‘the health care facility’’. (c) TITLE III; ADDITIONAL AMENDMENTS.— (1) EFFECTIVE DATE.—Section 301(b) of Public Law 107– 250 (116 Stat. 1616), is amended by striking ‘‘18 months’’ and inserting ‘‘36 months’’. 21 USC 352 note.
�
