H.R.2503 - FDA Scientific Fairness for Women Act

To amend the Federal Food, Drug, and Cosmetic Act with respect to the Office of Women's Health and the regulation of breast implants, and to provide for a scientific workshop on the use of emergency contraception by women under age 18. view all titles (2)

All Bill Titles

  • Short: FDA Scientific Fairness for Women Act as introduced.
  • Official: To amend the Federal Food, Drug, and Cosmetic Act with respect to the Office of Women's Health and the regulation of breast implants, and to provide for a scientific workshop on the use of emergency contraception by women under age 18. as introduced.

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Introduced
 
House
Passes
 
Senate
Passes
 
President
Signs
 

 
05/24/07
 
 
 
 
 
 
 

Official Summary

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

Official Summary

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.

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