[Congressional Record (Bound Edition), Volume 151 (2005), Part 13]
[House]
[Pages 17604-17608]
[From the U.S. Government Publishing Office, www.gpo.gov]




           MEDICAL DEVICE USER FEE STABILIZATION ACT OF 2005

  Mr. DEAL of Georgia. Mr. Speaker, I ask unanimous consent that the 
Committee on Energy and Commerce be discharged from further 
consideration of the bill (H.R. 3423) to amend the Federal Food, Drug, 
and Cosmetic Act with respect to medical device user fees, and ask for 
its immediate consideration in the House.
  The Clerk read the title of the bill.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Georgia?

[[Page 17605]]


  Ms. ESHOO. Mr. Speaker, reserving the right to object, and I do not 
intend to object, I yield to the gentleman from Georgia to explain his 
unanimous consent request.
  Mr. DEAL of Georgia. Mr. Speaker, I thank the gentlewoman from 
California for yielding.
  In 2002, Congress passed the Medical Device User Fee and 
Modernization Act, and it allowed the Food and Drug Administration to 
collect user fees from manufacturers who would submit applications for 
medical devices. This legislation was in response to the fact that 
there were many applications for new devices, and we were falling 
behind in the approval process.
  With the passage of this legislation, the FDA was authorized to add 
additional personnel, and have done so and have speeded up the approval 
time for these new devices.
  However, the legislation provided that Congress had to set and reach 
certain marks of appropriations for fiscal year 2003 and through 2005 
for this program to continue; and in the event we did not reach those 
targeted appropriation levels, then the program would expire at the end 
of this September. Unfortunately, Congress did not meet those targeted 
appropriation levels.

                              {time}  1845

  Since Congress did not reach the targeted appropriations required to 
keep the program in place, this user fee program will cease at the end 
of September, and the FDA will be required to start sending out notices 
of termination.
  So this legislation is essential to keep this very successful program 
in place, and it will allow us to retain the medical personnel who are 
working and approving device applications in a much more speedy and 
rapid fashion than they would have been able to do without the user fee 
being in place.
  Mr. Speaker, that is the purpose of this legislation is to extend the 
program.
  Ms. ESHOO. Further reserving the right to object, Mr. Speaker, I 
would like to make a few comments about H.R. 3423, the Medical Device 
User Fee Stabilization Act, which is being considered today. I am the 
lead Democrat, along with my colleague, on the committee, the gentleman 
from Pennsylvania (Mr. Pitts), who is also my neighbor across the hall 
from me in the Cannon House Office Building.
  In 2002, former Representative Greenwood and myself introduced the 
Medical Devices User Fee Modernization Act. It passed the House 
unanimously, and it was signed into law by the President. The goal of 
the bill was to eliminate FDA's backlog in approving new medical 
devices so that doctors and patients could more quickly benefit from 
them.
  While the law required device manufacturers to contribute toward 
FDA's cost in evaluating and approving new devices, the program was 
contingent on the Federal Government paying its fair share. If Federal 
funding did not reach the trigger level, the program would be 
eliminated. This legislation fixes the trigger so that the user fee 
program can continue.
  Specifically the bill will reduce the rate of user fee increases to 
the single-digit range for the remaining 2 years of the program. It 
will help small medical device companies, which is very important, 
because the small companies operate differently under different 
circumstances than the larger ones. The small device companies, it 
helps them to afford the cost to submit new medical devices for FDA 
review and approval. And finally, the bill will enhance labeling and 
tracking of reprocessed single-use devices. So this legislation before 
us only authorizes the program for 2 more years.
  It really is a significant accomplishment, and it allows us to now 
concentrate on making the device approval process even better in 2007. 
And I know that both of my colleagues, both the gentleman from Georgia 
(Mr. Deal), the subcommittee chairman, as well as my colleague, the 
gentleman from Pennsylvania (Mr. Pitts), are committed to that.
  I want to thank Ryan Long with Chairman Barton's staff; John Ford, 
who is seated here to my left, with Ranking Member Dingell's staff; and 
for Vanessa Kramer of my staff who has worked so hard on this. And it 
is because of all of them and their hard work that this bill has 
successfully reached the floor today.
  Mr. PITTS. Mr. Speaker, before 2002, the government funded the 
approval process for pacemakers, catheters, defibrillators, contact 
lenses, hip prosthetics, and other medical devices using only taxpayer 
funding.
  This publicly funded process was a mess. It significantly delayed 
Food and Drug Administration approval of new, life-saving medical 
devices and prevent patients from benefiting from this new technology. 
To end this delay, Congress unanimously passed The Medical Device User 
Fee and Modernization Act in 2002. MDUFMA overcame obstacles at the FDA 
that prevent timely approval of new life-saving medical technologies 
without compromising the safety of consumers.
  Modeled after a similar program used to approve medicines and 
pharmaceuticals, MDUFMA created a stable funding base for the FDA. It 
combines industry paid user fees and Congressional appropriations. As a 
result, the device approval time has been virtually cut in half. The 
program proved very popular among companies making these devices and 
the patients who have benefited from them.
  However, Congress built a trigger into the law. The trigger sun-sets 
the program on September 30, 2005 when Congress fails to appropriate 
the amount authorized under the 2002 law. Congress provided the $216.7 
million required in fiscal year 2005. But in 2003 and 2004, Congress 
shortchanged MDUFMA by $40 million. That shortfall will cause MDUFMA to 
expire on September 30th. We can't allow that to happen. Too much is at 
stake.
  H.R. 3243 renews MDUFMA for two years and brings some much needed 
stability to the program. In 2007 we will revisit a full 
reauthorization of MDUFMA and finetune the program. I urge my 
colleagues to support this bill. I'd like to thank my colleague, the 
gentlewoman from California, Ms. Eshoo, for her hard work on this 
legislation.
  Mr. BARTON of Texas. Mr. Speaker, on October 26, 2002, the Medical 
Device User Fee and Modernization Act, MDUFMA, was signed into law.


                 I. background and need for legislation

  MDUFMA amended the Federal Food Drug and Cosmetic Act, FFDCA, to 
authorize the Food and Drug Administration, FDA, to collect user fees 
from manufacturers who submit certain applications to market medical 
devices. The premise behind initiating a user fee program for medical 
devices was to provide for more timely and predictable review of 
medical device applications, as well as to make the necessary 
infrastructure investments required to conduct the review of 
increasingly complex medical device applications in the future in a 
timely and predictable fashion.
  The FFDCA as amended by MDUFMA, authorizes FDA to collect user fees 
for certain medical device applications in FY 2006 and FY 2007 only if 
certain conditions are met. MDUFMA specifies that for FY 2006 fees may 
not be assessed if the total amounts appropriated for FY 2003 through 
FY 2005 for FDA's device and radiological health program did not meet 
certain targets. Appropriations for FY 2003 through FY 2005 for FDA's 
device and radiological health program were below the amount specified 
in MDUFMA. This legislation modifies those conditions, minimum 
appropriation levels for FY 2003 through FY 2005, to allow FDA to 
continue to collect user fees until October 1, 2007.
  User fees make possible investments in information technology 
infrastructure and human capital, more comprehensive training for 
reviewers, greater use of experts in academia and the private sector, 
enhanced project management, increased guidance development, expanded 
participation in globalization and standards setting activities, and 
increased interaction with industry both before and during the 
application review process. As medical device applications become 
progressively more complex, this investment will become ever more 
necessary to keep up with performance standards that FDA has thus far 
been successful in meeting. Keeping the device review program on sound 
financial footing is essential to ensure timely and predictable review 
of medical device applications. Providing the device review program 
with sufficient resources to fulfill its mission is critical to ensure 
that patients have access to the latest and most effective technology.
  The Committee also believes it is important to provide industry with 
predictable annual increases in application fees. Since the inception 
of MDUFMA, user fees for certain application types have increased 
dramatically from year to year. To address these concerns, H.R. 3423 
will limit fee increases in FY 2006 and

[[Page 17606]]

FY 2007 until MDUFMA sunsets on October 1, 2007. This legislation is 
designed to provide a transition until Congress reauthorizes the 
program in 2007. During deliberations on the reauthorization of the 
program the Committee on Energy and Commerce recognizes the need to 
consider comprehensive changes to the structure of the program to 
provide for stability and predictability in both application fees and 
fee revenues for companies that pay user fees and for the FDA.


                    II. ANALYSIS OF THE LEGISLATION

  H.R. 3423 removes the requirement that the total amounts appropriated 
for FY 2003 through FY 2005 for FDA's device and radiological health 
program must meet levels specified in MDUFMA before FDA can collect 
user fees in FY 2006 and FY 2007. As a result, FDA will be able to 
collect user fees in FY 2006. To avoid similar problems in FY 2007, FDA 
may continue to collect user fees as long as appropriations are not 
more than 1 percent below the target amount.
  This legislation also provides industry with greater predictability 
as to the amount by which fees will increase over the next two fiscal 
years. The fee rate for a premarket approval application (PMA) will 
increase by 8.5 percent in FY 2006 to $259,600 and by 8.5 percent in FY 
2007 to $281,600. Small businesses will receive additional financial 
relief by expanding the definition of a small business to include 
entities that reported $100,000,000 or less of gross receipts or sales 
in their most recent Federal income tax return for a taxable year, 
except that the small business threshold for an entity to be eligible 
for a first time, full-fee waiver for a PMA application will remain at 
$30,000,000. For FY 2006 and FY 2007, FDA will report to Congress on 
the number of different applications and notifications, and the total 
amount of fees paid for each type, from businesses with gross receipts 
or sales at or below $100,000,000.
  To provide FDA with a measure of financial security should fee 
revenues fall short of current projections, the agency may use 
unobligated carryover balances from fees collected in previous fiscal 
years if the following conditions are met: (1) Insufficient fee 
revenues are available in that fiscal year, (2) the agency maintains 
unobligated carryover balances of not less than one month of operating 
reserves for the first month of FY 2008, and (3) the agency sends a 
notice to the Committee on Health, Education, Labor, and Pensions, the 
Committee on Energy and Commerce, and the Committee on Appropriations 
of the United States Senate and the United States House of 
Representatives at least 14 days prior to using these funds. To ensure 
that funds are not directed away from device safety activities, FDA 
must certify that the amounts spent by the agency for salaries and 
expenses to perform device-related activities not pertaining to the 
review of applications are no less than the amounts spent on those 
functions in FY 2002 multiplied by the rate of inflation.
  Section 301 of MDUFMA added a new subsection (u) to section 502 of 
the FFDCA that required devices or attachments to a device prominently 
and conspicuously to bear the name of the manufacturer of the original 
device or of the reprocessed device, if it was reprocessed, a generally 
recognized abbreviation of that entity, or a unique and generally 
recognized symbol identifying the manufacturer. This provision was 
intended to ensure that the manufacturer of the device, whether the 
original manufacturer or reprocessor, could be properly identified. In 
developing the original provisions of Section 301, the Committee 
believed it was important for device user facilities and the agency to 
have the ability to correctly identify the responsible party for a 
device when there is an adverse event associated with a device.
  However, under the current language of Section 301, the FDA could 
waive the branding requirement if compliance is not feasible or 
compromises the reasonable assurance of safety or effectiveness of the 
device. For some devices it may be difficult to comply with the marking 
requirement due to their physical characteristics, such as size and 
composition. Even if the physical characteristics make it difficult to 
mark a device, the Committee believes it is important that every device 
have a mechanism to identify the manufacturer of the product when there 
is an adverse event.
  Reporting of adverse events of medical devices by manufacturers and 
device user facilities is fundamental to the FDA's post-market 
regulation of medical devices. Concerns have been raised that once a 
medical device is removed from its packaging and placed on a tray ready 
for use on a patient, physicians and nurses are likely to identify the 
device with the OEM. While medical device user facilities are required 
to report manufacturer information beyond the product labeling, the 
lack of specific labeling to identify devices has led to claims of 
underreporting of patient injuries and product malfunctions involving 
reprocessed devices. It is important to the Committee that device 
facilities are properly reporting the manufacturer responsible for the 
device. The Committee believes the effectiveness of the FDA's medical 
device reporting system is undermined when the agency does not receive 
proper information regarding the party responsible for the safety of 
the device, and that FDA should take steps to ensure it is in fact 
receiving such information.
  The Committee has carefully considered the concerns about section 
502(u) as originally adopted and has amended it to provide for a more 
comprehensive provision that does not allow waivers to branding 
requirements. Section 502(u) now focuses on reprocessed single-use 
devices. Any single-use device reprocessed from an original device that 
the original manufacturer has prominently and conspicuously marked 
(which may be accomplished through marking an attachment to the device) 
with its name, a generally recognized abbreviation of its name, or a 
unique and a generally recognized symbol for it, must be prominently 
and conspicuously marked (which may be accomplished through marking an 
attachment to the device) with the reprocessor's name, a generally 
recognized abbreviation of its name, or a unique and a generally 
recognized symbol for it.
  H.R. 3423, while limiting compliance to reprocessed devices, allows 
such a device to satisfy this labeling requirement by using a 
detachable label that identifies the reprocessor if the original device 
did not prominently and conspicuously bear the name of, abbreviation 
of, or symbol for the manufacturer. Under this new provision, there 
will be no possibility of a waiver of the branding requirements, and 
every device should be traceable back to the responsible party. The 
Committee recognizes the benefits of the detachable label can only be 
recognized if the labels are used as intended by being affixed to a 
patient's medical records. The Committee believes the amended provision 
will strengthen the medical device reporting system. However, the 
Committee will continue to closely monitor the use of detachable labels 
by device user facilities to ensure that the intent of the provision is 
realized.
  Although the Committee encourages the use of these detachable labels 
on all reprocessed devices, the use of such a detachable label on a 
reprocessed single-use device that is prominently and conspicuously 
marked by the original manufacturer is not a legitimate substitute for 
the requirement of section 502(u)(I) that the reprocessor directly mark 
the reprocessed device or an attachment to it. In order to avoid 
erroneous identification of the original manufacturer as the source of 
a reprocessed device and to ensure that the MDR system provides FDA 
with the information it needs with respect to reprocessed devices to 
adequately protect patients, the identification of the reprocessor by 
means of a detachable package label is strictly limited to those 
circumstances where the device itself, or an attachment thereto, does 
not prominently and conspicuously reflect the identity of the original 
manufacturer.
  The effective date of this provision is 12 months from the date of 
enactment. In the interim, the FDA is charged with developing guidance 
to identify circumstances where the original equipment manufacturer's 
marking is not prominent and conspicuous. Section 519 of the FFDCA, and 
FDA's Medical Device Reporting (MDR) regulations, require manufacturers 
to report patient injuries and product malfunctions to FDA, and device 
user facilities to report these adverse events to FDA and 
manufacturers. The Committee believes that the requirements of section 
502(u), as amended, will operate to improve this post-market 
surveillance system, and thus patient safety. It is the intention of 
the Committee that upon the effective date of this provision device 
user facilities should in every instance be able to determine the 
proper party responsible for this device.
  For those devices that already contain a marking by the original 
equipment manufacturer the Committee believes that companies currently 
reprocessing devices should begin to place identifiable markings as 
soon as possible. The Committee also believes the 12-month effective 
date should give ample opportunity for the regulated companies to 
comply with this provision, and the Committee expects the FDA will 
enforce this provision on the date it becomes effective.

Section 1. Short title.

  This section provides the short title of the bill, the ``Medical 
Device User Fee Stabilization Act of 2005.''

Section 2. Amendments to the Federal Food, Drug and Cosmetic Act.

  This section amends Section 738 of the FFDCA (Authority to Assess and 
Use Device

[[Page 17607]]

Fees), Section 103 of MDUFMA, Section 502(u) of the FFDCA (Misbranded 
Devices), and Section 301(b) of MDUFMA.
  Subsection (a) addresses amendments to the device user fee program 
authorized in Section 738 of the FFDCA. Subsection (a)(1) eliminates 
the statutory fee revenue targets for device user fees in fiscal years 
2006 and 2007 in section 738(b).
  Subsection (a)(2) eliminates the inflationary, workload, 
compensating, and final year adjustments previously used in annual fee-
setting calculations, as provided for in Section 738(c). Subsection 
(a)(2) also sets the pre-market application user fee at $259,600 for 
fiscal year 2006 and $281,600 for fiscal year 2007, which is an 8.5 
percent increase each year (fees for other device submissions are then 
determined as a percentage of the pre-market application fee, as 
provided generally in section 738(a)(2)(A)). Finally, subsection (a)(2) 
also amends Section 738(c) to permit FDA to use up to two-thirds of 
fees carried over from previous years to supplement fee revenues in 
fiscal years 2006 and 2007. FDA must notify Congress if it intends to 
use these carryover balances.
  Subsection (a)(3) amends section 738(d) to clarify that the small 
business threshold for the purposes of a first-time waiver of the fee 
on a pre-market approval application or a pre-market report remains at 
$30 million, as under current law. It raises the small business 
threshold from $30 million to $100 million for the purposes of fee 
reductions on all other applications, reports, and supplements. 
Subsection (a)(3) also eliminates the ability of the FDA to reset this 
new small business threshold if user fee revenues are reduced by 16 
percent because of the small business fee reduction. Subsection (a)(4) 
amends section 738(e) to raise the small business threshold from $30 
million to $100 million for the purposes of fee reductions on pre-
market notifications.
  Subsection (a)(5) amends section 738(g) to eliminate the ``trigger'' 
requirement of additional appropriations in the FY 2003 and FY 2004 for 
FDA to be able to collect user fees in FY 2006 and FY 2007. It also 
builds in a 1 percent tolerance on the appropriations trigger for FY 
2006 and FY 2007, to cushion against possible across-the-board 
rescission in the appropriations process for those years, which would 
lead to accidental termination of the program.
  Subsection (a)(6) eliminates the statutory authorization targets for 
FY 2006 and FY 2007, and subsection (a)(7) makes a conforming amendment 
throughout Section 738.
  Subsection (b) amends section 103 of MDUFMA to require additional 
information in FDA's medical device user fee program annual reports for 
FY 2006 and FY 2007 on the number and types of applications received by 
the size of small business up to the new small business threshold of 
$100 million, and to require a certification by the Secretary of Health 
and Human Services in the annual report that appropriated funds 
obligated for other purposes relating to medical devices are not 
diverted for device review.
  Subsection (c)(1) amends section 502(u) of the FFDCA to address the 
marking and tracking of reprocessed medical devices intended for 
single-use by the original manufacturer. Section 502(u) as amended 
requires reprocessors to mark a reprocessed device if the original 
manufacturer has marked the device. If the original manufacturer does 
not mark the device, the reprocessor must still mark the device, but 
has more flexibility in how to mark the device, such as by using a 
detachable label on the package of the device that is intended to be 
placed in the medical record of the patient on whom the device is used.
  Subsection (c)(2) requires FDA to issue a guidance document no later 
than 180 days after the act becomes effective to address compliance 
with section 502(u) in circumstances where an original manufacturer has 
not marked the original device prominently and conspicuously.
  Subsection (d) amends section 301(b) of MDUFMA to make the amendment 
made by subsection (c)(1) to section 502(u) of the FFDCA effective 12 
months after the date of enactment of the act, or 12 months after the 
original manufacturer has first marked its device, if that is later.
   Ms. ESHOO Mr. Speaker, I withdraw my reservation of objection.
  The SPEAKER pro tempore (Mr. Hayes) Is there objection to the request 
of the gentleman from Georgia?
  There was no objection.
  The Clerk read the bill, as follows:

                               H.R. 3423

       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 Device User Fee 
     Stabilization Act of 2005''.

     SEC. 2. AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC 
                   ACT.

       (a) Device User Fees.--Section 738 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 379j) is amended--
       (1) in subsection (b)--
       (A) after ``2004;'', by inserting ``and''; and
       (B) by striking ``2005;'' and all that follows through 
     ``2007'' and inserting ``2005'';
       (2) in subsection (c)--
       (A) by striking the heading and inserting ``Annual Fee 
     Setting.--'';
       (B) by striking paragraphs (1), (2), (3), and (4);
       (C) by redesignating paragraphs (5) and (6) as paragraphs 
     (1) and (2), respectively;
       (D) in paragraph (1), as so redesignated, by--
       (i) striking the heading and inserting ``IN GENERAL.--'';
       (ii) striking ``establish, for the next fiscal year, and'' 
     and all that follows through ``the fees'' and inserting 
     ``publish in the Federal Register fees under subsection (a). 
     The fees'';
       (iii) striking ``2003'' and inserting ``2006''; and
       (iv) striking ``$154,000.'' and inserting ``$259,600, and 
     the fees established for fiscal year 2007 shall be based on a 
     premarket application fee of $281,600.''; and
       (E) by adding at the end the following:
       ``(3) Supplement.--
       ``(A) In general.--For fiscal years 2006 and 2007, the 
     Secretary may use unobligated carryover balances from fees 
     collected in previous fiscal years to ensure that sufficient 
     fee revenues are available in that fiscal year, so long as 
     the Secretary maintains unobligated carryover balances of not 
     less than 1 month of operating reserves for the first month 
     of fiscal year 2008.
       ``(B) Notice to congress.--Not later than 14 days before 
     the Secretary anticipates the use of funds described in 
     subparagraph (A), the Secretary shall provide notice to the 
     Committee on Health, Education, Labor, and Pensions and the 
     Committee on Appropriations of the Senate and the Committee 
     on Energy and Commerce and the Committee on Appropriations of 
     the House of Representatives.'';
       (3) in subsection (d)--
       (A) in paragraph (1), by inserting after the first sentence 
     the following: ``For the purposes of this paragraph, the term 
     `small business' means an entity that reported $30,000,000 or 
     less of gross receipts or sales in its most recent Federal 
     income tax return for a taxable year, including such returns 
     of all of its affiliates, partners, and parent firms.''; and
       (B) in paragraph (2)(A), by--
       (i) striking ``(i) IN GENERAL.--'';
       (ii) striking ``subsection,'' and inserting ``paragraph,'';
       (iii) striking ``$30,000,000'' and inserting 
     ``$100,000,000''; and
       (iv) striking clause (ii);
       (4) in subsection (e)(2)(A), by striking ``$30,000,000'' 
     and inserting ``$100,000,000'';
       (5) in subsection (g)(1)--
       (A) in subparagraph (B)--
       (i) by striking clause (i) and inserting the following:
       ``(i) For fiscal year 2005, the Secretary is expected to 
     meet all of the performance goals identified for the fiscal 
     year if the amount so appropriated for such fiscal year, 
     excluding the amount of fees appropriated for such fiscal 
     year, is equal to or greater than $205,720,000 multiplied by 
     the adjustment factor applicable to the fiscal year.''; and
       (ii) in clause (ii), by striking the matter preceding 
     subclause (I) and inserting the following:
       ``(ii) For fiscal year 2005, if the amount so appropriated 
     for such fiscal year, excluding the amount of fees 
     appropriated for such fiscal year, is more than 1 percent 
     less than the amount that applies under clause (i), the 
     following applies:'';
       (B) in subparagraph (C)--
       (i) in the matter preceding clause (i), by--

       (I) striking ``2003 through'' and inserting ``2005 and''; 
     and
       (II) inserting ``more than 1 percent'' after ``years, is''; 
     and

       (ii) in clause (ii), by striking ``sum'' and inserting 
     ``amount''; and
       (C) in subparagraph (D)(i), by inserting ``more than 1 
     percent'' after ``year, is'';
       (6) in subsection (h)(3)--
       (A) in subparagraph (C), by striking the semicolon and 
     inserting ``; and''; and
       (B) by striking subparagraphs (D) and (E) and inserting the 
     following:
       ``(D) such sums as may be necessary for each of fiscal 
     years 2006 and 2007.''; and
       (7) by striking ``subsection (c)(5)'' each place it appears 
     and inserting ``subsection (c)(1)''.
       (b) Annual Reports.--Section 103 of the Medical Device User 
     Fee and Modernization Act of 2002 (Public Law 107-250 (116 
     Stat. 1600)) is amended--
       (1) by striking ``Beginning with'' and inserting ``(a) In 
     General.--Beginning with''; and
       (2) by adding at the end the following:
       ``(b) Additional Information.--For fiscal years 2006 and 
     2007, the report described under subsection (a)(2) shall 
     include--
       ``(1) information on the number of different types of 
     applications and notifications, and

[[Page 17608]]

     the total amount of fees paid for each such type of 
     application or notification, from businesses with gross 
     receipts or sales from $0 to $100,000,000, with such 
     businesses categorized in $10,000,000 intervals; and
       ``(2) a certification by the Secretary that the amounts 
     appropriated for salaries and expenses of the Food and Drug 
     Administration for such fiscal year and obligated by the 
     Secretary for the performance of any function relating to 
     devices that is not for the process for the review of device 
     applications, as defined in paragraph (5) of section 737 of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i), 
     are not less than such amounts for fiscal year 2002 
     multiplied by the adjustment factor, as defined in paragraph 
     (7) of such section 737.''.
       (c) Misbranded Devices.--
       (1) In general.--Section 502(u) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 352(u)) is amended to read as 
     follows:
       ``(u)(1) Subject to paragraph (2), if it is a reprocessed 
     single-use device, unless it, or an attachment thereto, 
     prominently and conspicuously bears the name of the 
     manufacturer of the reprocessed device, a generally 
     recognized abbreviation of such name, or a unique and 
     generally recognized symbol identifying such manufacturer.
       ``(2) If the original device or an attachment thereto does 
     not prominently and conspicuously bear the name of the 
     manufacturer of the original device, a generally recognized 
     abbreviation of such name, or a unique and generally 
     recognized symbol identifying such manufacturer, a 
     reprocessed device may satisfy the requirements of paragraph 
     (1) through the use of a detachable label on the packaging 
     that identifies the manufacturer and is intended to be 
     affixed to the medical record of a patient.''.
       (2) Guidance.--Not later than 180 days after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services shall issue guidance to identify circumstances in 
     which the name of the manufacturer of the original device, a 
     generally recognized abbreviation of such name, or a unique 
     and generally recognized symbol identifying such 
     manufacturer, is not ``prominent and conspicuous'', as used 
     in section 502(u) of Federal Food, Drug, and Cosmetic Act (as 
     amended by paragraph (1)).
       (d) Effective Date.--Section 301(b) of the Medical Device 
     User Fee and Modernization Act of 2002 (Public Law 107-250 
     (116 Stat. 1616)), as amended by section 2(c) of Public Law 
     108-214 (118 Stat. 575), is amended to read as follows:
       ``(b) Effective Date.--Section 502(u) of the Federal Food, 
     Drug, and Cosmetic Act (as amended by section 2(c) of the 
     Medical Device User Fee Stabilization Act of 2005)--
       ``(1) shall be effective--
       ``(A) with respect to devices described under paragraph (1) 
     of such section, 12 months after the date of enactment of the 
     Medical Device User Fee Stabilization Act of 2005, or the 
     date on which the original device first bears the name of the 
     manufacturer of the original device, a generally recognized 
     abbreviation of such name, or a unique and generally 
     recognized symbol identifying such manufacturer, whichever is 
     later; and
       ``(B) with respect to devices described under paragraph (2) 
     of such section 502(u), 12 months after such date of 
     enactment; and
       ``(2) shall apply only to devices reprocessed and 
     introduced or delivered for introduction in interstate 
     commerce after such applicable effective date.''.

  The bill was ordered to be engrossed and read a third time, was read 
the third time, and passed, and a motion to reconsider was laid on the 
table.

                          ____________________