[108th Congress Public Law 214]
[From the U.S. Government Printing Office]


[DOCID: f:publ214.108]

[[Page 571]]

                MEDICAL DEVICES TECHNICAL CORRECTIONS ACT

[[Page 118 STAT. 572]]

Public Law 108-214
108th Congress

                                 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. <<NOTE: Apr. 
                         1, 2004 -  [S. 1881]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of <<NOTE: Medical Devices Technical Corrections 
Act.>> America in Congress assembled,

SECTION 1. <<NOTE: 21 USC 301 note.>> SHORT TITLE.

    This Act may be cited as the ``Medical Devices Technical Corrections 
Act''.

SEC. 2. TECHNICAL CORRECTIONS REGARDING PUBLIC LAW 107-250.

    (a) Title I; Fees Relating to Medical Devices.--Part 3 of subchapter 
C of chapter VII of the Federal 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 <<NOTE: 21 USC 379i.>> 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 substantial clinical data are 
                necessary to provide a reasonable assurance of safety 
                and effectiveness'';
                    (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 premarket report under section 
                515 or a premarket 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 <<NOTE: 21 USC 379j.>> 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

[[Page 118 STAT. 573]]

                                    (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 ``application'' 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), beginning 
                                in the second sentence, by striking 
                                ``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 filing''; 
                and
                    (E) in subsection (h)(2)(B)--
                          (i) in clause (ii), by redesignating 
                      subclauses (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 following:
                          ``(ii) More than 5 percent.--To the extent 
                      such costs are more than 5 percent below the 
                      specified level in subparagraph (A)(ii), fees may 
                      not be collected under this section for that 
                      fiscal year.''.

    (b) Title II; Amendments Regarding Regulation of Medical Devices.--
            (1) Inspections by accredited persons.--Section 704(g) of 
        the Federal Food, Drug, and Cosmetic 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 inspections of establishments 
                that manufacture, prepare, propagate, compound, or 
                process class II or class III devices, which inspections 
                are required 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 sentence, by 
                striking ``or poses'' and all that follows through the 
                period and inserting ``poses a threat to public health, 
                fails to act in a manner that is consistent with the 
                purposes of this subsection, or where the Secretary 
                determines that there is a financial conflict of 
                interest in the relationship between the accredited 
                person and the owner or operator of a device 
                establishment that the accredited person has inspected 
                under this subsection.'';

[[Page 118 STAT. 574]]

                    (C) in paragraph (6)(A)--
                          (i) in clause (i), by striking ``of the 
                      establishment pursuant to subsection (h) or (i) of 
                      section 510'' and inserting ``described in 
                      paragraph (1)'';
                          (ii) in clause (ii)--
                                    (I) in the matter preceding 
                                subclause (I)--
                                            (aa) by striking ``each 
                                        inspection'' and inserting 
                                        ``inspections''; and
                                            (bb) by inserting ``during a 
                                        2-year period'' after 
                                        ``person''; and
                                    (II) in subclause (I), by striking 
                                ``such a person'' and inserting ``an 
                                accredited person'';
                          (iii) in clause (iii)--
                                    (I) in the matter preceding 
                                subclause (I), by striking ``and the 
                                following additional conditions are 
                                met:'' and inserting ``and 1 or both of 
                                the following additional conditions are 
                                met:'';
                                    (II) in subclause (I), by striking 
                                ``accredited'' and all that follows 
                                through the period and inserting 
                                ``(accredited under paragraph (2) and 
                                identified under clause (ii)(II)) as a 
                                person authorized to conduct such 
                                inspections of device establishments.''; 
                                and
                                    (III) in subclause (II), by 
                                inserting ``or by a person accredited 
                                under paragraph (2)'' after ``by the 
                                Secretary'';
                          (iv) in clause (iv)(I)--
                                    (I) in the first sentence--
                                            (aa) by striking ``the two 
                                        immediately preceding 
                                        inspections of the 
                                        establishment'' and inserting 
                                        ``inspections of the 
                                        establishment during the 
                                        previous 4 years''; and
                                            (bb) by inserting 
                                        ``section'' after ``pursuant 
                                        to'';
                                    (II) in the third sentence--
                                            (aa) by striking ``the 
                                        petition states a commercial 
                                        reason for the waiver;''; and
                                            (bb) by inserting ``not'' 
                                        after ``the Secretary has not 
                                        determined that the public 
                                        health would''; and
                                    (III) in the fourth sentence, by 
                                striking ``granted until'' and inserting 
                                ``granted or deemed to be granted 
                                until''; and
                          (v) in clause (iv)(II)--
                                    (I) by inserting ``of a device 
                                establishment required to register'' 
                                after ``to be conducted''; and
                                    (II) by inserting ``section'' after 
                                ``pursuant to'';
                    (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 and other'' and 
                      inserting ``and with other''; and
                          (ii) in the second sentence--
                                    (I) by striking ``inspections'' and 
                                inserting ``inspectional findings''; and
                                    (II) by inserting ``relevant'' after 
                                ``together with all other'';

[[Page 118 STAT. 575]]

                    (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 
        inspections 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 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 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 
                Federal 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), <<NOTE: 21 USC 352 note.>> is amended by 
        striking ``18 months'' and inserting ``36 months''.

[[Page 118 STAT. 576]]

            (2) Premarket notification.--Section 510(o) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 360(o)), as added by 
        section 302(b) of Public Law 107-250 (116 Stat. 1616), is 
        amended--
                    (A) in paragraph (1)(B), by striking ``, 
                adulterated'' and inserting ``or adulterated''; and
                    (B) in paragraph (2)--
                          (i) in subparagraph (B), by striking ``, 
                      adulterated'' and inserting ``or adulterated''; 
                      and
                          (ii) in subparagraph (E), by striking 
                      ``semicritical'' and inserting ``semi-critical''.

    (d) Miscellaneous Corrections.--
            (1) Certain amendments to section 515.--
                    (A) In general.--
                          (i) Technical correction.--Section 515(c) of 
                      the Federal Food, Drug, and Cosmetic Act (21 
                      U.S.C. 360e(c)), as amended by sections 209 and 
                      302(c)(2)(A) of Public Law 107-250 (116 Stat. 
                      1613, 1618), is amended by redesignating paragraph 
                      (3) (as added by section 209 of such Public Law) 
                      as paragraph (4).
                          (ii) Modular review.--Section 515(c)(4)(B) of 
                      the Federal Food, Drug, and Cosmetic Act (21 
                      U.S.C. 360e(c)(4)(B)) is amended by striking 
                      ``unless an issue of safety'' and inserting 
                      ``unless a significant issue of safety''.
                    (B) Conforming amendment.--Section 210 of Public Law 
                107-250 (116 Stat. 1614) <<NOTE: 21 USC 360e.>> is 
                amended by striking
                ``, as amended'' and all that follows through ``by 
                adding'' and inserting ``is amended in paragraph (3), as 
                redesignated by section 302(c)(2)(A) of this Act, by 
                adding''.
            (2) Certain amendments to section 738.--
                    (A) In general.--Section 738(a) of the Federal Food, 
                Drug, and Cosmetic Act (21 U.S.C. 379j(a)), as amended 
                by subsection (a), is amended--
                          (i) in the matter preceding paragraph (1)--
                                    (I) by striking ``(a) Types of 
                                Fees.--Beginning on'' and inserting the 
                                following:

    ``(a) Types of Fees.--
            ``(1) In general.--Beginning on''; and
                                    (II) by striking ``this section as 
                                follows:'' and inserting ``this 
                                section.''; and
                          (ii) by striking ``(1) Premarket 
                      application,'' and inserting the following: ``(2) 
                      Premarket application,''.
                    (B) Conforming amendments.--Section 738 of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j), 
                as amended by subparagraph (A), is amended--
                          (i) in subsection (d)(1), in the last 
                      sentence, by striking ``subsection (a)(1)(A)'' and 
                      inserting ``subsection (a)(2)(A)'';
                          (ii) in subsection (e)(1), by striking 
                      ``subsection (a)(1)(A)(vii)'' and inserting 
                      ``subsection (a)(2)(A)(vii)'';
                          (iii) in subsection (e)(2)(C)--
                                    (I) in each of clauses (i) and (ii), 
                                by striking ``subsection 
                                (a)(1)(A)(vii)'' and inserting 
                                ``subsection (a)(2)(A)(vii)''; and

[[Page 118 STAT. 577]]

                                    (II) in clause (ii), by striking 
                                ``subsection (a)(1)(A)(i)'' and 
                                inserting ``subsection (a)(2)(A)(i)''; 
                                and
                          (iv) in subsection (j), by striking 
                      ``subsection (a)(1)(D),'' and inserting 
                      ``subsection (a)(2)(D),''.
                    (C) Additional conforming amendment.--Section 
                102(b)(1) of Public Law 107-250 (116 Stat. 
                1600) <<NOTE: 21 USC 379j note.>> is amended, in the 
                matter preceding subparagraph (A), by striking ``section 
                738(a)(1)(A)(ii)'' and inserting ``section 
                738(a)(2)(A)(ii)''.
            (3) Public law 107-250.--Public Law 107-250 is amended--
                    (A) in section 102(a) (116 Stat. 1589), <<NOTE: 21 
                USC 379i, 379j.>> by striking ``(21 U.S.C. 379F et 
                seq.)'' and inserting ``(21 U.S.C. 379f et seq.)'';
                    (B) in section 102(b) (116 Stat. 1600)--
                          (i) by striking paragraph (2);
                          (ii) in paragraph (1), by redesignating 
                      subparagraphs (A) and (B) as paragraphs (1) and 
                      (2), respectively; and
                          (iii) by striking:

    ``(b) Fee Exemption for Certain Entities Submitting Premarket 
Reports.--
            ``(1) In general.--A person submitting a premarket report'' 
        and inserting:

    ``(b) Fee Exemption for Certain Entities Submitting Premarket 
Reports.--A person submitting a premarket report''; and
                    (C) in section 212(b)(2) (116 Stat. 
                1614), <<NOTE: 21 USC 360l note.>> by striking ``, such 
                as phase IV trials,''.
SEC. 3. REPORT <<NOTE: Deadline.>> ON BARRIERS TO AVAILABILITY OF 
                    DEVICES INTENDED FOR CHILDREN.

    Not later than 180 days after the date of enactment of this Act, the 
Secretary of Health and Human Services shall submit to the Committee on 
Health, Education, Labor, and Pensions of the Senate and the Committee 
on Energy and Commerce of the House of Representatives a report on the 
barriers to the availability of devices intended for the treatment or 
diagnosis of diseases and conditions that affect children. The report 
shall include any recommendations of the Secretary of Health and Human 
Services for changes to existing statutory authority, regulations, or 
agency

[[Page 118 STAT. 578]]

policy or practice to encourage the invention and development of such 
devices.

    Approved April 1, 2004.

LEGISLATIVE HISTORY--S. 1881 (H.R. 3493):
---------------------------------------------------------------------------

HOUSE REPORTS: No. 108-433 (Comm. on Energy and Commerce).
CONGRESSIONAL RECORD:
                                                        Vol. 149 (2003):
                                    Nov. 25, considered and passed 
                                        Senate.
                                                        Vol. 150 (2004):
                                    Mar. 9, 10, considered and passed 
                                        House, amended.
                                    Mar. 12, Senate concurred in House 
                                        amendment.

                                  <all>