H.R. 2503 · 110th Congress
FDA Scientific Fairness for Women Act
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Never voted on. It didn't reach a floor vote before the 110th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
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DeLauroSponsor21 cosponsors · 21 D
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DeGette9 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
FDA Scientific Fairness for Women Act - Amends the Federal Food, Drug, and Cosmetic Act to establish the Office of Women's Health within the Office of the Commissioner of the Food and Drug Administration (FDA).
What it does: CRS summary · Introduced in House · May 24, 2007
FDA Scientific Fairness for Women Act - Amends the Federal Food, Drug, and Cosmetic Act to establish the Office of Women's Health within the Office of the Commissioner of the Food and Drug Administration (FDA).
Deems a breast implant to be a class III medical device. Requires premarket approval of breast implants irrespective of whether the implant has been cleared for commercial distribution in interstate commerce before the date of enactment of this Act.
Prohibits the Secretary of Health and Human Services from finding that a reasonable assurance of safety has been shown for an application for premarket approval for a a breast implant unless the applicant involved has demonstrated its safety for the life of the implant. Deems an already approved breast implant to be unsafe under the conditions of use prescribed, recommended, or suggested in the labeling.
Requires the Secretary to: (1) issue appropriate, voluntary guidance for clinical care, removal, and replacement for breast implants; (2) require such guidance to be clearly expressed in the labeling and all marketing materials; and (3) require dissemination of such guidance to patients who have already received the implant.
Requires the Breast Implant Advisory Panel of the General and Plastic Surgery Advisory Committee to review the results and quality of the research on saline breast implants and silicone gel implants.
Requires the Secretary to study the ionization and levels of platinum in silicone breast implants.
Requires the Secretary, acting through the Commissioner of Food and Drugs, to convene a scientific workshop to review and evaluate current scientific data on the use of emergency contraception by females of childbearing potential under the age of 18.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: FDA Scientific Fairness for Women Act
Latest action (May 24, 2007): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: May 24, 2007
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.