(iii) in clause (iii)—
(I) in the matter preceding sub-
clause (I), by striking ‘‘and the fol-
lowing additional conditions are met:’’
and inserting ‘‘and 1 or both of the
following additional conditions are
met:’’;
(II) in subclause (I), by striking
‘‘identified under subclause (II) of
this clause’’ and inserting ‘‘identified
under clause (ii)(II) as a person au-
thorized to conduct inspections of de-
vice establishments’’; and
(III) in subclause (II), by insert-
ing ‘‘or by a person accredited under
paragraph (2)’’ after ‘‘by the Sec-
retary’’;
(iv) in clause (iv)(I)—
(I) in the first sentence—
(aa) by striking ‘‘the two
immediately 
preceding 
inspec-
tions of the establishment’’ and
inserting ‘‘inspections of the es-
tablishment during the previous
4 years’’; and
(bb) by inserting ‘‘section’’
after ‘‘pursuant to’’;
(II) in the third sentence—
(aa) by striking ‘‘the peti-
tion states a commercial reason
for the waiver;’’; and
(bb) by inserting ‘‘not’’ after
‘‘the Secretary has not deter-
mined that the public health
would’’; and
(III) in the fourth sentence, by
striking ‘‘granted until’’ and inserting
‘‘granted or deemed to be granted
until’’;
(v) in clause (iv)(II)—
(I) by inserting ‘‘of a device es-
tablishment required to register’’ after
‘‘to be conducted’’; and
(II) by inserting ‘‘section’’ after
‘‘pursuant to’’; and
(vi) by adding at the end the following
clause:
‘‘(v) The eligibility of the establishment for in-
spections by accredited persons has not been sus-
pended under subparagraph (B)(iv)(II).’’;
(D) in paragraph (6)(B)(iii)—
(i) in the first sentence, by striking ‘‘,
and data otherwise describing whether the
establishment has consistently been in
compliance with sections 501 and 502’’;
(ii) in the second sentence—
(I) by striking ‘‘inspections’’ and
inserting ‘‘inspectional findings’’; and
(II) by inserting ‘‘relevant’’ after
‘‘together with all other’’; and
(iii)(I) by inserting ‘‘(I)’’ after ‘‘(iii)’’;
(II) by adding at the end the fol-
lowing subclause:
‘‘(II) In making a decision under this paragraph, the
Secretary may consider any information relevant to the
establishment’s compliance with any provision of this Act.
Nothing in the preceding sentence shall be construed to
expand the Secretary’s inspectional authority under sub-
section (a).’’;
(E) in paragraph (6)(B)(iv)—
(i) by inserting ‘‘(I)’’ after ‘‘(iv)’’; and
(ii) by adding at the end the following
subclause:
‘‘(II) If, during the two-year period following clear-
ance under subparagraph (A) with respect to a device es-
tablishment, the Secretary obtains information indicating
significant deviations from compliance with this Act or im-
plementing regulations, the Secretary may, after notice
and an opportunity for a written response, notify the es-
tablishment that the eligibility of the establishment for in-
spections by accredited person has been suspended.’’;
(F) in paragraph (6)(C)(ii), by striking ‘‘in
accordance with section 510(h), or has not dur-
ing such period been inspected pursuant to sec-
tion 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 sub-
section and the number of inspections con-
ducted by Federal employees pursuant to sec-
tion 510(h) and of device establishments re-
quired 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 Sec-
retary pursuant to inspections conducted
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 per-
son 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 Federal Food, Drug, and Cos-
metic 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 estab-
lishments’’ after ‘‘in health care facilities’’;