Home > 108th Congressional Public Laws > Pub.L. 108-215 To authorize the President of the United States to agree to certain ...

Pub.L. 108-215 To authorize the President of the United States to agree to certain ...


Google
 
Web GovRecords.org



[[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. 

Pages: 1 2 Next >>

Other Popular 108th Congressional Public Laws Documents:

1 Pub.L. 108-375 To authorize appropriations for fiscal year 2005 for military activities ...
2 Pub.L. 108-284 Providing for the appointment of Eli Broad as a citizen regent of the Board of Regents of the Smithsonian Institution. <> ...
3 Pub.L. 108-004 Making further continuing appropriations for the fiscal year 2003, and for other purposes. <> ...
4 Pub.L. 108-111 To designate the facility of the United States Postal Service located at 440 South Orange Blossom Trail in Orlando, Florida, as the ``Arthur `Pappy' Kennedy Post Office''. <> ...
5 Pub.L. 108-317 To establish Institutes to demonstrate and promote the use of adaptive ecosystem management to reduce the risk of wildfires, and restore the health of fire-adapted forest and woodland ecosystems of the interior West. <
6 Pub.L. 108-383 To amend title 44, United States Code, to improve the efficiency of operations by the National Archives and Records Administration and to reauthorize the National Historical Publications and Records Commission. <
7 Pub.L. 108-412 To require the Secretary of Agriculture to establish a program to provide assistance to eligible weed management entities to control or eradicate noxious weeds on public and private land. <> ...
8 Pub.L. 108-226 To designate the Federal building located at 250 West Cherry Street in Carbondale, Illinois the ``Senator Paul Simon Federal Building''. <> ...
9 Pub.L. 108-137 Making appropriations for energy and water development for the fiscal year ending September 30, 2004, and for other purposes. <> ...
10 Pub.L. 108-071 To designate the facility of the United States Postal Service located at 9350 East Corporate Hill Drive in Wichita, Kansas, as the ``Garner E. Shriver Post Office Building''. <> ...
11 Pub.L. 108-217 To provide for an additional temporary extension of programs under the Small Business Act and the Small Business Investment Act of 1958 through June 4, 2004, and for other purposes. <> ...
12 Pub.L. 108-380 To clarify the boundaries of the John H. Chafee Coast Barrier Resources System Cedar Keys Unit P25 on Otherwise Protected Area P25P. <> ...
13 Pub.L. 108-167 To authorize salary adjustments for Justices and judges of the United States for fiscal year 2004. <> ...
14 Pub.L. 108-351 To amend the Lease Lot Conveyance Act of 2002 to provide that the amounts received by the United States under that Act shall be deposited in the reclamation fund, and for other purposes. <> ...
15 Pub.L. 108-059 To extend the Abraham Lincoln Bicentennial Commission, and for other purposes. <> ...
16 Pub.L. 108-262 To reauthorize the Temporary Assistance for Needy Families block grant program through September 30, 2004, and for other purposes. <> ...
17 Pub.L. 108-038 Expressing the sense of Congress with respect to raising awareness and encouraging prevention of sexual assault in the United States and supporting the goals and ideals of National Sexual Assault Awareness and Prevention Month. <
18 Pub.L. 108-208 To provide for the protection of archaeological sites in the Galisteo Basin in New Mexico, and for other purposes. <> ...
19 Pub.L. 108-168 To reauthorize the National Transportation Safety Board, and for other purposes. <> ...
20 Pub.L. 108-364 To amend the Assistive Technology Act of 1998 to support programs of grants to States to address the assistive technology needs of individuals with disabilities, and for other purposes. <> ...
21 Pub.L. 108-336 To provide for the implementation of air quality programs developed in ...
22 Pub.L. 108-094 To direct the Secretary of the Interior to conduct a study of Coltsville in the State of Connecticut for potential inclusion in the National Park System. <> ...
23 Pub.L. 108-109 To provide for the establishment by the Secretary of Veterans Affairs of additional cemeteries in the National Cemetery Administration. <> ...
24 Pub.L. 108-384 To provide for the control and eradication of the brown tree snake on the island of Guam and the prevention of the introduction of the brown tree snake to other areas of the United States, and for other purposes. <
25 Pub.L. 108-345 To redesignate the Ridges Basin Reservoir, Colorado, as Lake Nighthorse. <> ...
26 Pub.L. 108-073 To extend for six months the period for which chapter 12 of title 11 of the United States Code is reenacted. <> ...
27 Pub.L. 108-090 Making appropriations for the Department of Homeland Security for the fiscal year ending September 30, 2004, and for other purposes. <> ...
28 Pub.L. 108-128 To revise the boundary of the Black Canyon of the Gunnison National Park and Gunnison Gorge National Conservation Area in the State of Colorado, and for other purposes. <> ...
29 Pub.L. 108-400 To amend the Colorado Canyons National Conservation Area and Black Ridge Canyons Wilderness Act of 2000 to rename the Colorado Canyons National Conservation Area as the McInnis Canyons National Conservation Area. <
30 Pub.L. 108-149 To designate the facility of the United States Postal Service located at 514 17th Street in Moline, Illinois, as the ``David Bybee Post Office Building''. <> ...


Other Documents:

108th Congressional Public Laws Records and Documents

GovRecords.org presents information on various agencies of the United States Government. Even though all information is believed to be credible and accurate, no guarantees are made on the complete accuracy of our government records archive. Care should be taken to verify the information presented by responsible parties. Please see our reference page for congressional, presidential, and judicial branch contact information. GovRecords.org values visitor privacy. Please see the privacy page for more information.
House Rules:

104th House Rules
105th House Rules
106th House Rules

Congressional Bills:

104th Congressional Bills
105th Congressional Bills
106th Congressional Bills
107th Congressional Bills
108th Congressional Bills

Supreme Court Decisions

Supreme Court Decisions

Additional

1995 Privacy Act Documents
1997 Privacy Act Documents
1994 Unified Agenda
2004 Unified Agenda

Congressional Documents:

104th Congressional Documents
105th Congressional Documents
106th Congressional Documents
107th Congressional Documents
108th Congressional Documents

Congressional Directory:

105th Congressional Directory
106th Congressional Directory
107th Congressional Directory
108th Congressional Directory

Public Laws:

104th Congressional Public Laws
105th Congressional Public Laws
106th Congressional Public Laws
107th Congressional Public Laws
108th Congressional Public Laws

Presidential Records

1994 Presidential Documents
1995 Presidential Documents
1996 Presidential Documents
1997 Presidential Documents
1998 Presidential Documents
1999 Presidential Documents
2000 Presidential Documents
2001 Presidential Documents
2002 Presidential Documents
2003 Presidential Documents
2004 Presidential Documents

Home Executive Judicial Legislative Additional Reference About Privacy