Federal Register Notice: FDA is making available a draft guidance document entitled “Saline, Silicone Gel, and Alternative Breast Implants.” This version of the draft guidance document updates preclinical, clinical, and labeling recommendations described in Guidance for Saline, Silicone Gel, and Alternative Breast Implants dated 2/11/03. The update clarifies the type and amount of scientific data that should be submitted to allow FDA to evaluate whether these devices are safe and effective. To download this guidance, click here. To view this notice, click here.
