H.R. 3493 · 108th Congress
Medical Devices Technical Corrections Act of 2003
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1 cosponsor · 1 D
1 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
- House Introduced Nov 17, 2003
- House Passed Jan 27, 2004 333–0
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.
What it does: CRS summary · Passed House without amendment · Jan 27, 2004
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 the accreditation to inspect from any person where the Secretary has information indicating a relationship between the company and the accredited inspector that may create a conflict of interest.
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 obtains information indicating significant deviations from compliance with the Act or implementing regulations.
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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
Votes to become law
About this bill and sources
Official title: Medical Devices Technical Corrections Act
Latest action (Jan 28, 2004): Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Policy area: Health · Origin: House · Introduced: Nov 17, 2003
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML) · Embed in your story
- House Introduced Nov 17, 2003
- House Passed Jan 27, 2004 333–0
Final vote · House · Jan 27, 2004
Passage (two-thirds required) — Passed. Vote details
Speaker of the House: J. Dennis Hastert