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FDA Scientific Fairness for Women Act

Introduced: May 24, 2007 Introduced by: DeLauro, Rosa L. Democratic · Connecticut See on congress.gov
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
May 24, 2007
Referred to the Subcommittee on Health.
May 24, 2007
Referred to the House Committee on Energy and Commerce.
May 24, 2007
Introduced in House
 Plain-English summary Congressional Research Service

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.

What's happening now May 24, 2007

Referred to the Subcommittee on Health.

 Committees of jurisdiction 2