PDF Printer Version
(87 KB)

29-006

108TH CONGRESS
REPORT

HOUSE OF REPRESENTATIVES
2d Session

108-433

--MEDICAL DEVICES TECHNICAL CORRECTIONS ACT

MARCH 9, 2004- Committed to the Committee of the Whole House on the State of the Union and ordered to be printed

Mr. BARTON of Texas, from the Committee on Energy and Commerce, submitted the following

R E P O R T

[To accompany S. 1881]

[Including cost estimate of the Congressional Budget Office]

SECTION 1. SHORT TITLE.

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

(aa) by striking `each inspection' and inserting `inspections'; and

(bb) by inserting `during a 2-year period' after `person'; and

(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';

(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

SEC. 3. REPORT ON BARRIERS TO AVAILABILITY OF DEVICES INTENDED FOR CHILDREN.

PURPOSE AND SUMMARY

S. 1881 makes technical and conforming changes to the Medical Device User Fee and Modernization Act of 2002.

BACKGROUND AND NEED FOR LEGISLATION

On October 26, 2002, President Bush signed into law the Medical Device User Fee and Modernization Act of 2002 (P.L. 107-250). This legislation provided increased resources to the Food and Drug Administration (FDA) through user fees and made other significant reforms to the FDA in order to improve the quality and speed of medical device approvals, but is in need of technical corrections.

HEARINGS

The Committee on Energy and Commerce has not held hearings on the legislation.

COMMITTEE CONSIDERATION

On March 3, 2004, the Full Committee met in open markup session and favorably ordered S. 1881 reported to the House, as amended, by a voice vote, a quorum being present.

COMMITTEE VOTES

Clause 3(b) of rule XIII of the Rules of the House of Representatives requires the Committee to list the record votes on the motion to report legislation and amendments thereto. There were no record votes taken in connection with ordering S. 1881 reported. A motion by Mr. Barton to order S. 1881 reported to the House, as amended, was agreed to by a voice vote.

COMMITTEE OVERSIGHT FINDINGS

Pursuant to clause 3(c)(1) of rule XIII of the Rules of the House of Representatives, the Committee has not held oversight or legislative hearings on this legislation.

STATEMENT OF GENERAL PERFORMANCE GOALS AND OBJECTIVES

The goal of S. 1881 is to make technical and conforming changes to the Medical Device User Fee and Modernization Act of 2002.

NEW BUDGET AUTHORITY, ENTITLEMENT AUTHORITY, AND TAX EXPENDITURES

In compliance with clause 3(c)(2) of rule XIII of the Rules of the House of Representatives, the Committee finds that S. 1881, the Medical Device Technical Corrections Act, would result in no new or increased budget authority, entitlement authority, or tax expenditures or revenues.

COMMITTEE COST ESTIMATE

The Committee adopts as its own the cost estimate prepared by the Director of the Congressional Budget Office pursuant to section 402 of the Congressional Budget Act of 1974.

CONGRESSIONAL BUDGET OFFICE ESTIMATE

Pursuant to clause 3(c)(3) of rule XIII of the Rules of the House of Representatives, the following is the cost estimate provided by the Congressional Budget Office pursuant to section 402 of the Congressional Budget Act of 1974:

Hon. JOE BARTON,
Chairman, Committee on Energy and Commerce, House of Representatives, Washington, DC.

DEAR MR. CHAIRMAN: The Congressional Budget Office has prepared the enclosed cost estimate for S. 1881, the Medical Devices Technical Corrections Act.

If you wish further details on this estimate, we will be pleased to provide them. The CBO staff contact is Julia Christensen.

Sincerely,
Douglas Holtz-Eakin,
Director.

Enclosure.

S. 1881--Medical Devices Technical Corrections Act

S. 1881 would make technical changes regarding the Medical Device User Fee and Modernization Act of 2002 (Public Law 107-250). CBO estimates that enacting S. 1881 would have a negligible impact on the Federal budget and have no effect on direct spending or receipts.

The act would clarify the existing statute underlying the Food and Drug Administration's (FDA's) user fee program for medical devices. We anticipate that those modifications would not significantly change the costs for FDA to administer the program, nor would it affect user fee collections. S. 1881 also would require the Secretary of Health and Human Services to conduct a study on the availability of medical devices for children. Assuming the availability of appropriated funds, CBO estimates that implementing S. 1881 would cost less than $500,000 a year.

This legislation contains no intergovernmental or private-sector mandates as defined in the Unfunded Mandates Reform Act and would impose no costs on State, local, or tribal governments.

The CBO staff contact for this estimate is Julia Christensen. This estimate was approved by Peter H. Fontaine, Deputy Assistant Director for Budget Analysis.

FEDERAL MANDATES STATEMENT

The Committee adopts as its own the estimate of Federal mandates prepared by the Director of the Congressional Budget Office pursuant to section 423 of the Unfunded Mandates Reform Act.

ADVISORY COMMITTEE STATEMENT

No advisory committees within the meaning of section 5(b) of the Federal Advisory Committee Act were created by this legislation.

CONSTITUTIONAL AUTHORITY STATEMENT

Pursuant to clause 3(d)(1) of rule XIII of the Rules of the House of Representatives, the Committee finds that the Constitutional authority for this legislation is provided in Article I, section 8, clause 3, which grants Congress the power to regulate commerce with foreign nations, among the several States, and with the Indian tribes.

APPLICABILITY TO LEGISLATIVE BRANCH

The Committee finds that the legislation does not relate to the terms and conditions of employment or access to public services or accommodations within the meaning of section 102(b)(3) of the Congressional Accountability Act.

SECTION-BY-SECTION ANALYSIS OF THE LEGISLATION

Section 1. Short title

Section 1 designates the short title as the `Medical Device Technical Corrections Act.'

Section 2. Technical amendments regarding Public Law 107-250

Section 2 makes several technical changes to the Medical Device User Fee and Modernization Act of 2002 (P.L. 107-250). It renumbers and conforms the appropriate sections of the Federal Food, Drug, and Cosmetic Act, making grammatical corrections, inserting periods, and correcting comma placement.

Section 2 clarifies the distinction between a `panel track supplement' for which substantial clinical data is required to demonstrate a reasonable assurance of safety and effectiveness and a `180-day supplement' for which such data is not required. Next, section 2 clarifies that premarket reports are within the definition of `process for the review of device applications.' Further, section 2 clarifies the term `affiliate' to include international as well as domestic affiliates in the user fee program.

Section 2 makes technical changes clarifying that the third party inspection program applies to 510(h) inspections of establishments and inspections of foreign facilities required to register with the Food and Drug Administration (FDA). Section 2 ensures that facilities can work with third party inspectors to allow them to complete a full 510(h) inspection over the course of a two year period. Section 2 clarifies the law and allows entities to certify that a foreign country recognizes the third party conducting the inspection, instead of requiring a statement that such a country recognizes FDA's inspectional authority. Section 2 also ensures that companies can use third party inspectors for two consecutive 510(h) inspections before requesting special permission from the Secretary for the third such inspection. Finally, section 2 makes important modifications to section 301 by providing an 18-month implementation delay for all branding requirements and clarifies the definition of modular review to be consistent with the FDA's modular review program.

Section 3. Report on barriers to availability of devices intended for children

Section 3 requests that the FDA complete a report on the barriers to the availability of devices intended for pediatric patients, and provide policy recommendations as to what could be changed in existing law to address this issue.

CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED

FEDERAL FOOD, DRUG, AND COSMETIC ACT

* * * * * * *

CHAPTER III--PROHIBITED ACTS AND PENALTIES

PROHIBITED ACTS

* * * * * * *

* * * * * * *

CHAPTER V--DRUGS AND DEVICES

SUBCHAPTER A--DRUGS AND DEVICES

* * * * * * *

MISBRANDED DRUGS AND DEVICES

* * * * * * *

* * * * * * *

REGISTRATION OF PRODUCERS OF DRUGS AND DEVICES

* * * * * * *

* * * * * * *

* * * * * * *

* * * * * * *

PREMARKET APPROVAL

GENERAL REQUIREMENT

* * * * * * *

APPLICATION FOR PREMARKET APPROVAL

* * * * * * *

* * * * * * *

CHAPTER VII--GENERAL AUTHORITY

SUBCHAPTER A--GENERAL ADMINISTRATIVE PROVISIONS

* * * * * * *

FACTORY INSPECTION

* * * * * * *

* * * * * * *

* * * * * * *

* * * * * * *

* * * * * * *

* * * * * * *

* * * * * * *

* * * * * * *

* * * * * * *

* * * * * * *

* * * * * * *

SUBCHAPTER C--FEES

* * * * * * *

PART 3--FEES RELATING TO DEVICES

SEC. 737. DEFINITIONS.

* * * * * * *

* * * * * * *

* * * * * * *

* * * * * * *

* * * * * * *

* * * * * * *

SEC. 738. AUTHORITY TO ASSESS AND USE DEVICE FEES.

* * * * * * *

* * * * * * *

* * * * * * *

* * * * * * *

* * * * * * *

* * * * * * *

* * * * * * *

* * * * * * *

* * * * * * *

-

MEDICAL DEVICE USER FEE AND MODERNIZATION ACT OF 2002

(Public Law 107-250)

* * * * * * *

TITLE I--FEES RELATED TO MEDICAL DEVICES

* * * * * * *

SEC. 102. ESTABLISHMENT OF PROGRAM.

* * * * * * *

* * * * * * *

* * * * * * *

SEC. 210. PEDIATRIC EXPERTISE REGARDING CLASSIFICATION-PANEL REVIEW OF PREMARKET APPLICATIONS.

* * * * * * *

SEC. 212. STUDY BY INSTITUTE OF MEDICINE OF POSTMARKET SURVEILLANCE REGARDING PEDIATRIC POPULATIONS.

* * * * * * *

SEC. 301. IDENTIFICATION OF MANUFACTURER OF MEDICAL DEVICES.

* * * * * * *