Medical Devices Technical Corrections Act

Bill: 108-s-1881
Sponsor: Sen. Alexander, Lamar [R-TN]
Introduced: 2003-11-18 in the Senate
Policy area: Health
Subjects: 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

Summary:
action_date: 2003-11-18
text: 
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 &quot;pediatric patient&quot; as a patient under 14 years old at the time of treatment or diagnosis.)
action_date: 2003-11-25
text: 
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. 

action_date: 2004-03-09
text: 
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. 

action_date: 2004-03-10
text: 

(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. 

action_date: 2004-04-01
text: 

(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. 


Legislative actions:
action_date: 2004-04-01
text: Became Public Law No: 108-214.
action_date: 2004-04-01
text: Became Public Law No: 108-214.
action_date: 2004-04-01
text: Signed by President.
action_date: 2004-04-01
text: Signed by President.
action_date: 2004-03-22
text: Presented to President.
action_date: 2004-03-22
text: Presented to President.
action_date: 2004-03-15
text: Message on Senate action sent to the House.
action_date: 2004-03-12
text: Senate agreed to House amendment  by Unanimous Consent. (text as Senate agreed to House amendment: CR S2821-2822)
action_date: 2004-03-12
text: Resolving differences -- Senate actions: Senate agreed to House amendment  by Unanimous Consent.(text as Senate agreed to House amendment: CR S2821-2822)
action_date: 2004-03-11
text: Message on House action received in Senate and at desk: House amendment to Senate bill.
action_date: 2004-03-10
text: Motion to reconsider laid on the table Agreed to without objection.
action_date: 2004-03-10
text: 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)
action_date: 2004-03-10
text: 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)
action_date: 2004-03-10
text: Considered as unfinished business. (consideration: CR H931-932)
action_date: 2004-03-09
text: 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.
action_date: 2004-03-09
text: DEBATE - The House proceeded with forty minutes of debate on S. 1881.
action_date: 2004-03-09
text: Considered under suspension of the rules. (consideration: CR H890-892)
action_date: 2004-03-09
text: Mr. Greenwood moved to suspend the rules and pass the bill, as amended.
action_date: 2004-03-09
text: Placed on the Union Calendar, Calendar No. 250.
action_date: 2004-03-09
text: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 108-433.
action_date: 2004-03-09
text: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 108-433.
action_date: 2004-03-03
text: Ordered to be Reported (Amended) by Voice Vote.
action_date: 2004-03-03
text: Committee Consideration and Mark-up Session Held.
action_date: 2003-12-17
text: Referred to the Subcommittee on Health.
action_date: 2003-12-08
text: Referred to the House Committee on Energy and Commerce.
action_date: 2003-12-08
text: Message on Senate action sent to the House.
action_date: 2003-12-08
text: Received in the House.
action_date: 2003-11-25
text: Passed Senate with an amendment by Unanimous Consent. (consideration: CR S16057-16060; text of measure as reported to Senate: CR S16058-16060)
action_date: 2003-11-25
text: 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)
action_date: 2003-11-24
text: Placed on Senate Legislative Calendar under General Orders. Calendar No. 412.
action_date: 2003-11-24
text: Committee on Health, Education, Labor, and Pensions. Reported by Senator Gregg with an amendment in the nature of a substitute. Without written report.
action_date: 2003-11-24
text: Committee on Health, Education, Labor, and Pensions. Reported by Senator Gregg with an amendment in the nature of a substitute. Without written report.
action_date: 2003-11-21
text: Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
action_date: 2003-11-18
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
action_date: 2003-11-18
text: Introduced in Senate

Enacted as: number: 108-214