107th Congress

Medical Device User Fee and Modernization Act of 2002

P.L. 107-250 (H.R. 5651)

Impact of Public Law

Section 215 of the Medical Device User Fee and Modernization Act of 2002 amends the Public Health Service Act to authorize the Director of the National Institutes of Health (NIH) to conduct or support research to examine the long-term health implications of silicone breast implants. This authorization includes studies to 1) develop and examine techniques to measure concentrations of silicone in body fluids and tissues, and 2) track silicone breast implant recipients. Breast implant is defined in the law as a "breast prosthesis that is implanted to augment or reconstruct the female breast."

Within 6 months of enactment, the Director of NIH is required to submit a report to Congress describing the status of research on breast implants being conducted or supported by the Agency.

Legislative History

On October 16, 2002, Representative Jim Greenwood (R-PA) introduced H.R. 5651, the Medical Device User Fee and Modernization Act of 2002. The bill was referred to the House Committee on Energy and Commerce; however, Representative Richard K. Armey (R-TX) asked for unanimous consent to discharge the bill from committee and send it to the floor for a vote. The bill was passed by unanimous consent on October 16 and received in the Senate on the same day. The Senate passed the bill on October 17. The bill was signed by the President on October 26, 2002, as P.L. 107-250.