[Congressional Record (Bound Edition), Volume 150 (2004), Part 1]
[House]
[Pages 454-457]
[From the U.S. Government Publishing Office, www.gpo.gov]




               MEDICAL DEVICES TECHNICAL CORRECTIONS ACT

  Mr. GREENWOOD. Mr. Speaker, I move to suspend the rules and pass the 
bill (H.R. 3493) 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, as amended.
  The Clerk read as follows:

                               H.R. 3493

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. 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 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 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 ``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 
     inserting after ``standards of accreditation,'' 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 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 ``identified under 
     subclause (II) of this clause'' and inserting ``identified 
     under clause (ii)(II) as a person authorized to conduct 
     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'';

       (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''; and

       (vi) by adding at the end the following clause:
       ``(v) The eligibility of the establishment for inspections 
     by accredited persons has not been suspended 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 following 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 
     subsection (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 clearance 
     under subparagraph (A) with respect to a device 
     establishment, the Secretary obtains information indicating 
     significant deviations from compliance with

[[Page 455]]

     this Act or implementing regulations, the Secretary may, 
     after notice and an opportunity for a written response, 
     notify the establishment that the eligibility of the 
     establishment for inspections by accredited person 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), is amended by striking ``18 months'' and 
     inserting ``36 months''.
       (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) 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
       (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) 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), 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), by striking ``, 
     such as phase IV trials,''.

     SEC. 3. REPORT 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 policy or 
     practice to encourage the invention and development of such 
     devices.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Pennsylvania (Mr. Greenwood) and the gentleman from Ohio (Mr. Brown) 
each will control 20 minutes.
  The Chair recognizes the gentleman from Pennsylvania (Mr. Greenwood).


                             General Leave

  Mr. GREENWOOD. Mr. Speaker, I ask unanimous consent that all Members 
may have 5 legislative days within which to revise and extend their 
remarks and insert extraneous material on H.R. 3493.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Pennsylvania?
  There was no objection.
  Mr. GREENWOOD. Mr. Speaker, I yield myself such time as I may 
consume.
  Mr. Speaker, H.R. 3493 is a bill that I introduced with the 
gentlewoman from California (Ms. Eshoo), which seeks to make technical 
and clarifying amendments to the Medical Device User Fee and 
Modernization Act of 2002 (MDUFMA). That bill, which was signed into 
law by President Bush on October 26, 2002, made sweeping changes to the 
laws that govern medical device approvals to establish new programs and 
streamline processes to accelerate the availability of medical devices 
to patients. For example, MDUFMA established a user fee program that 
will provide substantial new resources to speed up the approval of the 
medical devices. It streamlined the approval of combination products 
such as drug-coated stents which are one of the most exciting new areas 
of technology. It expanded the role of third parties and outside 
experts to augment the FDA resources to help FDA meet its beneficial 
manufacturing inspection requirements; and MDUFMA also extended the use 
of third-party review programs for 1 year so that it expires in 
conjunction with other device provisions.
  The legislation before us today amends the Medical Device User Fee 
Modernization Act to ensure that it is being implemented properly. 
While some of the amendments are truly technical, others clarify the 
intentions of Congress. For example, this legislation ensures that the 
user fee reductions that apply to small businesses apply for 2004 and 
years in the future. In addition, the legislation clarifies that as 
part of the third-party inspection program, companies must submit 
reports of inspectional findings consistent with current FDA practices.

[[Page 456]]



                              {time}  1445

  H.R. 3493 clarifies which data need to be submitted for a firm to be 
eligible for third-party inspection.
  Medical devices are some of our health care system's most remarkable 
innovations. The provisions in this technical and clarifying amendments 
bill will allow the FDA to continue to reduce review times, increase 
the efficiency of its operations and allow these wonderful technologies 
to be delivered to patients more quickly.
  I want to thank the gentleman from Louisiana (Mr. Tauzin), the 
gentleman from Florida (Mr. Bilirakis), the gentleman from Michigan 
(Mr. Dingell) and the gentleman from Ohio (Mr. Brown) as well as the 
gentleman from California (Mr. Waxman) and each of their staffs for 
this legislation. This has been another outstanding example of teamwork 
and bipartisanship on the part of the Committee on Energy and Commerce.
  Mr. Speaker, I urge a ``yes'' vote on this bill.
  Mr. Speaker, I reserve the balance of my time.
  Mr. BROWN of Ohio. Mr. Speaker, I yield myself such time as I may 
consume.
  I am pleased to support this legislation which is intended to, and 
will, help ensure that FDA's medical device user fee and third-party 
review programs operate as intended. The goal of these programs is to 
promote timely access to medical devices without compromising FDA's 
ability to properly evaluate both the safety and the effectiveness of 
those devices. Successful bipartisan negotiations produced the 
authorizing legislation for these programs, and it is the same with 
this follow-up measure today.
  I commend the gentlewoman from California (Ms. Eshoo) and the 
gentleman from Pennsylvania (Mr. Greenwood) as well as the gentleman 
from Louisiana (Mr. Tauzin), the gentleman from Michigan (Mr. Dingell) 
and the gentleman from Florida (Mr. Bilirakis), the subcommittee Chair, 
for their leadership on this successful committee effort. 
Unfortunately, the need for noncontroversial technical corrections is 
not the only obstacle preventing the medical device user fee program 
from fulfilling its potential. It is important for colleagues on both 
sides of the aisle to be aware that continuation of the user fee 
program, and it is this program that enables patients to receive 
cutting-edge medical devices on a timely basis, the continuation of the 
user fee program does in fact hinge on the appropriations process.
  User fees do no incremental good if they supplant, rather than 
supplement, Federal spending. As in the successful prescription drug 
user fee program, the continuation of user fees depends on sufficient 
annual appropriations. Last year's appropriation for medical device 
reviews was insufficient to sustain the medical device user fee program 
in an optimal way. If this year's appropriation does not address that 
shortfall, the user fee program will likely fold.
  Hard work went into establishing this program. The existence of the 
program enables patients more timely access to medical devices at no 
additional cost to American taxpayers. We need to make sure the program 
does not indeed fold.
  I hope the President's budget includes sufficient funding for the 
user fee program, and I hope we follow through by allocating sufficient 
dollars to keep this program alive.
  Mr. Speaker, I reserve the balance of my time.
  Mr. GREENWOOD. Mr. Speaker, I reserve the balance of my time.
  Mr. BROWN of Ohio. Mr. Speaker, I yield 5 minutes to the gentlewoman 
from California (Ms. Eshoo), one of the architects of this bill.
  Ms. ESHOO. Mr. Speaker, I thank our distinguished ranking member and 
my colleague, the gentleman from Pennsylvania (Mr. Greenwood) who, 
together we introduced this legislation, H.R. 3493. I appreciate always 
his cooperation and that of his staff. This is not the first effort 
where we have worked together and been successful. We are proud of that 
and proud of the work that has come out of our committee.
  This bill makes important technical corrections. While it may seem a 
little dull and dry, the technical corrections really enhance the 
Medical Device User Fee and Modernization Act which was a very 
important piece of legislation which allowed major new programs that 
really streamline the Food and Drug Administration's medical device 
approval process to be actually implemented. This bipartisan bill is 
about making sure that patients are, one, able to safely benefit from 
new medical technologies and, secondly, as quickly as possible. As 
medical technologies become more advanced, it takes more attention and 
resources to ensure that these products are safe and effective.
  Last year, the House overwhelmingly passed the Medical Device User 
Fee and Modernization Act which helps the FDA get lifesaving products 
to patients faster, as well as resources to the agency to assure this. 
Specifically under that law, and I think it is important to underscore 
what was in that law and why we are bolstering it, the importance of 
bolstering it today, the medical device industry agreed to pay fees to 
the FDA for every product it proposes to market. These fees will help 
the FDA hire additional staff, much needed, I might add, and to 
purchase needed equipment so that they can review the products on a 
timely basis.
  Secondly, the resources were increased for additional inspections of 
manufacturing plants and facilities, a very, very important part of 
that legislation, as well as the creation of an Office of Combination 
Products to shepherd advanced products, such as devices with drug 
coating, through the approval process. This new administrative 
flexibility allows the FDA to devote its resources to the devices that 
patients need most.
  Finally, the bill created a way to regulate what are known as 
reprocessed devices. Some people may have tuned into nationally 
televised programs where the national discovery was made that 
reprocessed devices were being used in hospitals unbeknownst to doctors 
and unbeknownst to patients. I did not like that when I heard it, and 
we addressed it in the bill.
  The bill requires that reprocessed products undergo additional 
scrutiny by the FDA and that they be held to the highest standards that 
the FDA can apply. It also required that doctors, who are often unaware 
that they are using a reprocessed device, be informed about the reused 
device so that they can, in turn, inform their patients about the 
reused device.
  This Technical Corrections Act is an important bill because it is 
ultimately, Mr. Speaker, about patients, and it will implement the 
Medical Device User Fee and Modernization Act as Congress fully 
intended.
  One of the best parts of doing something like this is to work with 
the very able people that helped make it possible, so I want to thank 
the gentleman from Louisiana (Mr. Tauzin), chairman of our full 
committee; the gentleman from Florida (Mr. Bilirakis), our 
distinguished subcommittee chairman; the gentleman from Michigan (Mr. 
Dingell), ranking member of our full committee; the gentleman from 
California (Mr. Waxman) and certainly my colleague, who is the ranking 
member of the Subcommittee on Health.
  I also want to thank several staff people: Pat Ronan of Chairman 
Tauzin's staff; Alan Eisenberg of the office of the gentleman from 
Pennsylvania (Mr. Greenwood); John Ford of the office of the gentleman 
from Michigan (Mr. Dingell); and Anne Witt of the office of the 
gentleman from California (Mr. Waxman). Without all of these good 
people, we would not be here today doing this. So we have come a long 
way, and I think we have created something that will serve our country 
very well.
  I urge all of my colleagues to vote for this, to make it unanimous. 
We will then accomplish yet something else very good and important for 
the American people.
  Mr. BROWN of Ohio. Mr. Speaker, I yield back the balance of my time.
  Mr. GREENWOOD. Mr. Speaker, I yield myself the balance of my time.
  I also would like to thank my very able staff member, Mr. Alan 
Eisenberg, for his tireless work on this and so many other issues.

[[Page 457]]


  Ms. JACKSON-LEE of Texas, Mr. Speaker, I rise today as a supporter of 
H.R. 3493 which amends Federal Food, Drug, and Cosmetic Act. This 
legislation is necessary to clarify certain provisions relating to the 
Medical Device User Fee and Modernization Act of 2002. I am pleased to 
see that this bill enjoys broad bipartisan support in this body after 
it was passed by unanimous consent in the Senate. It is imperative that 
we continually update and rework the regulations that govern the use of 
our Nation's medical devices.
  I would also like to recognize my distinguished colleague 
Representative Sherrod Brown and affirm his view on the necessity of 
providing additional appropriations funding for the Medical Device User 
Program. In the last series of appropriations this vital program was 
under funded and was left with a potentially dangerous mandate. While 
H.R. 3493 is a timely bill, we must make sure to provide the necessary 
resources for all medical device programs in order to make this 
legislation truly effective.
  Mr. ENGEL. Mr. Speaker, I rise today in support of the Medical 
Devices Technical Corrections Act. This bipartisan legislation makes 
technical corrections to the Medical Device User Fee and Modernization 
Act of 2002, which I was proud to cosponsor.
  The Medical Device User Fee and Modernization Act has several key 
components that will result in a better, more efficient process in 
which the Food and Drug Administration works with medical device 
companies to review applications, inspect device plants, and ensure 
that reprocessed devices are used in a safe and identifiable fashion. 
The user fees included in the legislation are intended to provide FDA 
with additional resources to review new or updated device applications 
more quickly, but also more effectively. Every day, medical devices 
save or improve the lives of patients around the world and this 
legislation will mean that patients will have access to new and 
improved devices in a much timelier fashion.
  Mr. Speaker, the manner in which the Energy and Commerce Committee 
worked to enact the original bill and the legislation before us today 
should be a model for future legislative efforts. Because of the truly 
bipartisan process, the Medical Device User Fee and Modernization Act 
enjoys widespread support which will work to ensure its success. I 
commend the medical device community and my colleagues for their 
efforts to improve the delivery of health care to millions of 
Americans.
  Mr. GREENWOOD. Mr. Speaker, I have no further requests for time, and 
I yield back the balance of my time.
  The SPEAKER pro tempore (Mr. Simpson). The question is on the motion 
offered by the gentleman from Pennsylvania (Mr. Greenwood) that the 
House suspend the rules and pass the bill, H.R. 3493, as amended.
  The question was taken.
  The SPEAKER pro tempore. In the opinion of the Chair, two-thirds of 
those present have voted in the affirmative.
  Mr. GREENWOOD. Mr. Speaker, on that I demand the yeas and nays.
  The yeas and nays were ordered.
  The SPEAKER pro tempore. Pursuant to clause 8 of rule XX and the 
Chair's prior announcement, further proceedings on this motion will be 
postponed.

                          ____________________