Zdrowie i gospodarka · 13/01/2004

FDA Releases Draft Guidance for Breast Implant Industry and Staff

The Food and Drug Administration (FDA) has released a draft guidance document titled "Saline, Silicone Gel, and Alternative Breast Implants," which updates preclinical, clinical, and labeling recommendations for breast implants. The document clarifies the type and amount of scientific data required for FDA evaluation of breast implant safety and effectiveness.