3.0.0 1881 2023-01-15T10:47:54Z 2023-01-15T10:47:54Z Senate S S 2003-11-18 108 hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2003-12-17T15:55:34Z Reported by 2004-03-09T19:35:59Z Markup by 2004-03-03T21:15:10Z Referred to 2003-12-08T19:57:53Z sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Reported by 2003-11-24T16:47:07Z Markup by 2003-11-22T00:39:53Z Referred to 2003-11-18T22:18:58Z H. Rept. 108-433 Medical Devices Technical Corrections Act 108 3493 HR 2004-01-28 Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS Related bill House 2004-04-01 Became Public Law No: 108-214. President E40000 2 House floor actions 2004-04-01 Became Public Law No: 108-214. BecameLaw 36000 9 Library of Congress 2004-04-01 Signed by President. President E30000 2 House floor actions 2004-04-01 Signed by President. BecameLaw 36000 9 Library of Congress 2004-03-22 Presented to President. Floor E20000 2 House floor actions 2004-03-22 Presented to President. President 28000 9 Library of Congress 2004-03-15 Senate Message on Senate action sent to the House. Floor 2004-03-12 Senate Senate agreed to House amendment by Unanimous Consent. (text as Senate agreed to House amendment: CR S2821-2822) ResolvingDifferences 2004-03-12 Resolving differences -- Senate actions: Senate agreed to House amendment by Unanimous Consent.(text as Senate agreed to House amendment: CR S2821-2822) NotUsed 20500 9 Library of Congress 2004-03-11 Senate Message on House action received in Senate and at desk: House amendment to Senate bill. Floor 2004-03-10 10:46:37 Motion to reconsider laid on the table Agreed to without objection. Floor H38310 2 House floor actions 2004-03-10 10:46:36 On motion to suspend the rules and pass the bill, as amended Agreed to by the Yeas and Nays: (2/3 required): 396 - 0 (Roll no. 46). (text: CR 3/9/2004 H890-891) Floor H37300 2 House floor actions 46 https://clerk.house.gov/evs/2004/roll046.xml House 108 2004-03-10T15:46:36Z 2 2004-03-10 10:46:36 Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by the Yeas and Nays: (2/3 required): 396 - 0 (Roll no. 46).(text: CR 3/9/2004 H890-891) Floor 8000 9 Library of Congress 46 https://clerk.house.gov/evs/2004/roll046.xml House 108 2004-03-10T15:46:36Z 2 2004-03-10 10:37:40 Considered as unfinished business. (consideration: CR H931-932) Floor H30000 2 House floor actions 2004-03-09 15:20:15 At the conclusion of debate, the Yeas and Nays were demanded and ordered. Pursuant to the provisions of clause 8, rule XX, the Chair announced that further proceedings on the motion would be postponed. Floor H37220 2 House floor actions 2004-03-09 15:13:55 DEBATE - The House proceeded with forty minutes of debate on S. 1881. Floor H8D000 2 House floor actions 2004-03-09 15:13:51 Considered under suspension of the rules. (consideration: CR H890-892) Floor H30000 2 House floor actions 2004-03-09 15:13:30 Mr. Greenwood moved to suspend the rules and pass the bill, as amended. Floor H30300 2 House floor actions 2004-03-09 Placed on the Union Calendar, Calendar No. 250. Calendars H12410 2 House floor actions U00250 2004-03-09 Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 108-433. Committee H12200 2 House floor actions hsif00 Energy and Commerce Committee 2004-03-09 Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 108-433. Committee 5000 9 Library of Congress hsif00 Energy and Commerce Committee 2004-03-03 hsif00 Energy and Commerce Committee 1 House committee actions Ordered to be Reported (Amended) by Voice Vote. Committee 2004-03-03 hsif00 Energy and Commerce Committee 1 House committee actions Committee Consideration and Mark-up Session Held. Committee 2003-12-17 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2003-12-08 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2003-12-08 Senate Message on Senate action sent to the House. Floor 2003-12-08 09:30:58 Received in the House. Floor H14000 2 House floor actions 2003-11-25 Senate Passed Senate with an amendment by Unanimous Consent. (consideration: CR S16057-16060; text of measure as reported to Senate: CR S16058-16060) Floor 2003-11-25 Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.(consideration: CR S16057-16060; text of measure as reported to Senate: CR S16058-16060) Floor 17000 9 Library of Congress 2003-11-24 Senate Placed on Senate Legislative Calendar under General Orders. Calendar No. 412. Calendars 2003-11-24 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Reported by Senator Gregg with an amendment in the nature of a substitute. Without written report. Committee 2003-11-24 Committee on Health, Education, Labor, and Pensions. Reported by Senator Gregg with an amendment in the nature of a substitute. Without written report. Committee 14000 9 Library of Congress sshr00 Health, Education, Labor, and Pensions Committee 2003-11-21 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably. Committee 2003-11-18 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2003-11-18 Introduced in Senate IntroReferral 10000 9 Library of Congress A000360 Sen. Alexander, Lamar [R-TN] Lamar Alexander R TN N M001111 Sen. Murray, Patty [D-WA] Patty Murray D WA 2003-11-18 True E000285 Sen. Enzi, Michael B. [R-WY] MICHAEL ENZI R WY B. 2003-11-18 True G000445 Sen. Gregg, Judd [R-NH] Judd Gregg R NH 2003-11-18 True 2004-03-08T06:00:00Z S. 1881, Medical Devices Technical Corrections Act http://www.cbo.gov/publication/15348 <p>Cost estimate for the bill as ordered reported by the House Committee on Energy and Commerce on March 3, 2004</p> 2004-03-08T06:00:00Z S. 1881, Medical Devices Technical Corrections Act https://www.cbo.gov/publication/15348 Cost estimate for the bill as ordered reported by the House Committee on Energy and Commerce on March 3, 2004 Public Law 108-214 Health Accreditation (Medical care) Administrative remedies Artificial implants Biomedical engineering Blood banks Business records Child health Commerce Conflict of interests Department of Health and Human Services Economics and Public Finance Exports Families Federal aid to research Food and Drug Administration (FDA) Foreign Trade and International Finance Government Operations and Politics Government paperwork Governmental investigations Labeling Law Manufacturing industries Medical research Medical supplies Medical technology Medical tests Product safety Prosthesis Research grants Science, Technology, Communications User charges Women Women's health Health 00 2003-11-18 Introduced in Senate 2004-01-30T19:47:33Z Medical Devices Technical Corrections Act - Amends the Federal Food, Drug, and Cosmetic Act, as amended by the Medical Device User Fee and Modernization Act of 2002, to revise medical device fee schedule provisions.

Revises facility inspection and accredited inspector provisions, including permitting a company that markets at least one medical device in the United States and one medical device in another country to satisfy inspection requirements by: (1) certifying that a foreign country recognizes Food and Drug Administration (FDA) inspection; and/or (2) marketing its devices in a country that recognizes third party inspectors. (Current law requires a company to meet both requirements.)

Includes within permitted electronic labeling provisions in vitro diagnostic devices intended for use by health care professionals or in blood establishments.

Extends the effective date of the provision deeming a device introduced into interstate commerce to be misbranded if the identification of the manufacturer is not conspicuously displayed from 18 months to 36 months after enactment of the Medical Device User Fee and Modernization Act of 2002 (October 26, 2002).

Permits a person to sell a device under the humanitarian exemption from certain effectiveness requirements for more than its research, fabrication, and distribution costs if: (1) such device is intended for pediatric treatment or diagnosis; and (2) the exemption request is made on or after October 1, 2007. (Defines "pediatric patient" as a patient under 14 years old at the time of treatment or diagnosis.)]]> 35 2003-11-25 Passed Senate amended 2004-03-16T17:02:00Z Medical Devices Technical Corrections Act - Amends the Federal Food, Drug, and Cosmetic Act (as amended by the Medical Device User Fee and Modernization Act of 2002) to revise provisions concerning medical devices user fees.

Prohibits the Secretary of Health and Human Services from collecting fees to defray costs in any fiscal year where the amount appropriated is more than five percent below the costs of the resources allocated for the review of device applications.

Permits a company that markets at least one medical device in the United States and one medical device in another country to use an accredited third party inspector if the company certifies that the foreign country recognizes inspections by: (1) the Food and Drug Administration (FDA); and/or (2) the third party inspector. (Current law requires a country to recognize both types of inspections.)

Allows electronic labeling for prescription devices intended for use by health care professionals and for in vitro diagnostic devices intended for use by health care professionals or in blood establishments.

Delays by 18 additional months the effective date of the provision deeming a device misbranded if the identification of the manufacturer is not conspicuously displayed.

Directs the Secretary to submit a report to the relevant committees on the barriers to the availability of devices intended for treatment or diagnosis of diseases or conditions that affect children.

]]> 17 2004-03-09 Reported to House with amendment(s) 2004-03-16T17:01:48Z Medical Devices Technical Corrections Act - Amends the Federal Food, Drug, and Cosmetic Act (as amended by the Medical Device User Fee and Modernization Act of 2002) to revise provisions concerning medical devices user fees.

Prohibits the Secretary of Health and Human Services from collecting fees to defray costs in any fiscal year where the amount appropriated is more than five percent below the costs of the resources allocated for the review of device applications.

Allows the Secretary to withdraw accreditation to inspect from any person where the Secretary determines that there is a conflict of interest between the company and the accredited inspector.

Permits a company that markets at least one medical device in the United States and one medical device in another country to use an accredited third party inspector if the company certifies that the foreign country recognizes inspections by: (1) the Food and Drug Administration (FDA); and/or (2) the third party inspector. (Current law requires a country to recognize both types of inspections.)

Allows the Secretary to withdraw eligibility for third party inspections from a company if the Secretary determines that the company is substantially not in compliance with the Act.

Allows electronic labeling for prescription devices intended for use by health care professionals and for in vitro diagnostic devices intended for use by health care professionals or in blood establishments.

Delays by 18 additional months the effective date of the provision deeming a device misbranded if the identification of the manufacturer is not conspicuously displayed.

Directs the Secretary to submit a report to the relevant committees on the barriers to the availability of devices intended for treatment or diagnosis of diseases or conditions that affect children.

]]> 36 2004-03-10 Passed House amended 2004-03-16T17:02:15Z (This measure has not been amended since it was reported to the House on March 9, 2004. The summary of that version is repeated here.)

Medical Devices Technical Corrections Act - Amends the Federal Food, Drug, and Cosmetic Act (as amended by the Medical Device User Fee and Modernization Act of 2002) to revise provisions concerning medical devices user fees.

Prohibits the Secretary of Health and Human Services from collecting fees to defray costs in any fiscal year where the amount appropriated is more than five percent below the costs of the resources allocated for the review of device applications.

Allows the Secretary to withdraw accreditation to inspect from any person where the Secretary determines that there is a conflict of interest between the company and the accredited inspector.

Permits a company that markets at least one medical device in the United States and one medical device in another country to use an accredited third party inspector if the company certifies that the foreign country recognizes inspections by: (1) the Food and Drug Administration (FDA); and/or (2) the third party inspector. (Current law requires a country to recognize both types of inspections.)

Allows the Secretary to withdraw eligibility for third party inspections from a company if the Secretary determines that the company is substantially not in compliance with the Act.

Allows electronic labeling for prescription devices intended for use by health care professionals and for in vitro diagnostic devices intended for use by health care professionals or in blood establishments.

Delays by 18 additional months the effective date of the provision deeming a device misbranded if the identification of the manufacturer is not conspicuously displayed.

Directs the Secretary to submit a report to the relevant committees on the barriers to the availability of devices intended for treatment or diagnosis of diseases or conditions that affect children.

]]> 49 2004-04-01 Public Law 2004-04-09T19:23:32Z (This measure has not been amended since it was reported to the House on March 9, 2004. The summary of that version is repeated here.)

Medical Devices Technical Corrections Act - Amends the Federal Food, Drug, and Cosmetic Act (as amended by the Medical Device User Fee and Modernization Act of 2002) to revise provisions concerning medical devices user fees.

Prohibits the Secretary of Health and Human Services from collecting fees to defray costs in any fiscal year where the amount appropriated is more than five percent below the costs of the resources allocated for the review of device applications.

Allows the Secretary to withdraw accreditation to inspect from any person where the Secretary determines that there is a conflict of interest between the company and the accredited inspector.

Permits a company that markets at least one medical device in the United States and one medical device in another country to use an accredited third party inspector if the company certifies that the foreign country recognizes inspections by: (1) the Food and Drug Administration (FDA); and/or (2) the third party inspector. (Current law requires a country to recognize both types of inspections.)

Allows the Secretary to withdraw eligibility for third party inspections from a company if the Secretary determines that the company is substantially not in compliance with the Act.

Allows electronic labeling for prescription devices intended for use by health care professionals and for in vitro diagnostic devices intended for use by health care professionals or in blood establishments.

Delays by 18 additional months the effective date of the provision deeming a device misbranded if the identification of the manufacturer is not conspicuously displayed.

Directs the Secretary to submit a report to the relevant committees on the barriers to the availability of devices intended for treatment or diagnosis of diseases or conditions that affect children.

]]> Medical Devices Technical Corrections Act Display Title Medical Devices Technical Corrections Act Official Title as Introduced A bill to amend the Federal Food, Drug, and Cosmetic Act to make technical corrections relating to the amendments by the Medical Device User Fee and Modernization Act of 2002, and for other purposes. Introduced in Senate IS Short Titles as Passed House Medical Devices Technical Corrections Act H House Short Titles as Introduced Medical Devices Technical Corrections Act Short Titles as Enacted Medical Devices Technical Corrections Act Short Titles as Passed Senate Medical Devices Technical Corrections Act S Senate Short Titles as Reported to House Medical Devices Technical Corrections Act H House Enrolled Bill Engrossed Amendment House 2004-03-10T05:00:00Z Reported in House 2004-03-09T05:00:00Z Referred in House 2003-12-08T05:00:00Z Engrossed in Senate 2003-11-25T05:00:00Z Reported to Senate 2003-11-24T05:00:00Z Introduced in Senate 2003-11-18T05:00:00Z 2004-04-02T04:59:59Z https://www.govinfo.gov/content/pkg/PLAW-108publ214/xml/PLAW-108publ214.xml Public Law 2004-04-01 Became Public Law No: 108-214. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.