108TH CONGRESS
2D SESSION
H. R. 3493
AN ACT
To amend the Federal Food, Drug, and Cosmetic Act to
make technical corrections relating to the amendments
made by the Medical Device User Fee and Modernization
Act of 2002, and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Medical Devices Tech-
nical Corrections Act’’.
SEC. 2. TECHNICAL CORRECTIONS REGARDING PUBLIC
LAW 107–250.
(a) TITLE I; FEES RELATING
TO MEDICAL DE-
VICES.—Part 3 of subchapter C of chapter VII of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 379i et
seq.), as added by section 102 of Public Law 107–250
(116 Stat. 1589), is amended—
(1) in section 737—
(A) in paragraph (4)(B), by striking ‘‘and
for which clinical data are generally necessary
to provide a reasonable assurance of safety and
effectiveness’’ and inserting ‘‘and for which sub-
stantial clinical data are necessary to provide a
reasonable assurance of safety and effective-
ness’’;
(B) in paragraph (4)(D), by striking
‘‘manufacturing,’’;
(C) in paragraph (5)(J), by striking ‘‘a
premarket application’’ and all that follows and
inserting ‘‘a premarket application or pre-
market report under section 515 or a pre-
market application under section 351 of the
Public Health Service Act.’’; and
(D) in paragraph (8), by striking ‘‘The
term ‘affiliate’ means a business entity that has
a relationship with a second business entity’’
and inserting ‘‘The term ‘affiliate’ means a
business entity that has a relationship with a
second business entity (whether domestic or
international)’’; and
(2) in section 738—
(A) in subsection (a)(1)—
(i) in subparagraph (A)—
(I) in the matter preceding clause
(i) by striking ‘‘subsection (d),’’ and
inserting ‘‘subsections (d) and (e),’’;
(II) in clause (iv), by striking
‘‘clause (i),’’ and all that follows and
inserting ‘‘clause (i).’’; and
(III) in clause (vii), by striking
‘‘clause (i),’’ and all that follows and
inserting ‘‘clause (i), subject to any
adjustment 
under 
subsection
(e)(2)(C)(ii).’’; and
(ii) in subparagraph (D), in each of
clauses (i) and (ii), by striking ‘‘applica-
tion’’ and inserting ‘‘application, report,’’;
(B) in subsection (d)(2)(B), beginning in
the second sentence, by striking ‘‘firms. which
show’’ and inserting ‘‘firms, which show’’;
(C) in subsection (e)—
(i) in paragraph (1), by striking
‘‘Where’’ and inserting ‘‘For fiscal year
2004 and each subsequent fiscal year,
where’’; and
(ii) in paragraph (2)—
(I) in subparagraph (B), begin-
ning in the second sentence, by strik-
ing ‘‘firms. which show’’ and inserting
‘‘firms, which show’’; and
(II) in subparagraph (C)(i), by
striking ‘‘Where’’ and inserting ‘‘For
fiscal year 2004 and each subsequent
fiscal year, where’’;
(D) in subsection (f), by striking ‘‘for fil-
ing’’; and
(E) in subsection (h)(2)(B)—
(i) in clause (ii), by redesignating sub-
clauses (I) and (II) as items (aa) and (bb),
respectively;
(ii) by redesignating clauses (i) and
(ii) as subclauses (I) and (II), respectively;
(iii) by striking ‘‘The Secretary’’ and
inserting the following:
‘‘(i) IN
GENERAL.—The Secretary’’;
and
(iv) by adding at the end the fol-
lowing:
‘‘(ii) MORE
THAN
PERCENT.—To
the extent such costs are more than 5 per-
cent below the specified level in subpara-
graph (A)(ii), fees may not be collected
under this section for that fiscal year.’’.
(b) TITLE II; AMENDMENTS REGARDING REGULA-
TION OF MEDICAL DEVICES.—
(1) INSPECTIONS BY ACCREDITED PERSONS.—
Section 704(g) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 374(g)), as added by section
201 of Public Law 107–250 (116 Stat. 1602), is
amended—
(A) in paragraph (1), in the first sentence,
by striking ‘‘conducting inspections’’ and all
that follows and inserting ‘‘conducting inspec-
tions of establishments that manufacture, pre-
pare, propagate, compound, or process class II
or class III devices, which inspections are re-
quired under section 510(h) or are inspections
of such establishments required to register
under section 510(i).’’;
(B) in paragraph (5)(B), in the first sen-
tence, by inserting after ‘‘standards of accredi-
tation,’’ the following: ‘‘or where the Secretary
has information indicating that the relationship
between the establishment and the accredited
person may create a conflict of interest,’’;
(C) in paragraph (6)(A)—
(i) in clause (i), by striking ‘‘of the es-
tablishment pursuant to subsection (h) or
(i) of section 510’’ and inserting ‘‘de-
scribed in paragraph (1)’’;
(ii) in clause (ii)—
(I) in the matter preceding sub-
clause (I)—
(aa) by striking ‘‘each in-
spection’’ and inserting ‘‘inspec-
tions’’; and
(bb) by inserting ‘‘during a
2-year period’’ after ‘‘person’’;
and
(II) in subclause (I), by striking
‘‘such a person’’ and inserting ‘‘an ac-
credited person’’;