retary shall specify in writing the basis for the 
objection, including any reasons why the ac-
credited person is not capable of performing the 
review in a manner which provides a reasonable 
assurance of the safety and effectiveness of the 
device for its intended purpose.’’. 
(d) ACCREDITATION.—Section 523(b) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360m(b)) is 
amended— 
(1) in paragraph (2)— 
(A) in the heading of subparagraph (C), by 
inserting ‘‘AND TRAINING’’ after ‘‘AUDITING’’; 
(B) in subparagraph (C)— 
(i) in clause (i), by striking ‘‘and’’ at 
the end; 
(ii) by redesignating clause (ii) as 
clause (iii); and 
(iii) by inserting after clause (i) the 
following: 
‘‘(ii) provide for the initial training 
and periodic updating of training of such 
person; and’’; and 
(C) by adding at the end the following: 
‘‘(E) PERIODIC REACCREDITATION.— 
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‘‘(i) PERIOD.—Subject to suspension 
or withdrawal under subparagraph (B), 
any accreditation under this section shall 
be valid for a period of 3 years after its 
issuance. 
‘‘(ii) RESPONSE TO REACCREDITATION 
REQUEST.—Upon the submission of a re-
quest by an accredited person to be re-
accredited under this section, the Secretary 
shall approve or deny such request not 
later than 60 days after receipt of the re-
quest. 
‘‘(iii) CRITERIA.—Not later than 120 
days after the date of the enactment of 
this subparagraph, the Secretary shall es-
tablish and publish in the Federal Register 
criteria to reaccredit or deny reaccredita-
tion to persons under this section. The re-
accreditation of persons under this section 
shall specify the particular activities under 
subsection (a) for which such persons are 
accredited.’’; 
(2) in paragraph (3)— 
(A) in subparagraph (A), by inserting ‘‘a 
sole practitioner or’’ after ‘‘may not be’’; 
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(B) in subparagraph (B), by striking 
‘‘such a manufacturer, supplier, or vendor’’ and 
inserting ‘‘a manufacturer, supplier, or vendor 
of devices of the type for which such person is 
accredited’’; and 
(C) in subparagraph (D), by striking ‘‘de-
vices’’ and inserting ‘‘devices of the type for 
which such person is accredited’’; 
(3) by striking paragraph (4) (relating to selec-
tion of accredited persons); and 
(4) by redesignating paragraph (5) as para-
graph (4). 
(e) DURATION OF AUTHORITY.—Section 523(c) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360m(c)) is amended by striking ‘‘October 1, 2012’’ and 
inserting ‘‘October 1, 2017’’. 
(f) REPORT.—Section 523(d) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360m(d)) is amended 
by striking ‘‘January 10, 2007’’ and inserting ‘‘January 
15, 2015’’. 
SEC. 3. PERSONS ACCREDITED TO CONDUCT INSPECTIONS. 
Section 704(g)(11) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 374(g)(11)) is amended by strik-
ing ‘‘October 1, 2012’’ and inserting ‘‘October 1, 2017’’. 
Æ 
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