This article was originally published in The Gray Sheet
Comments on draft entitled "Guidance on Preclinical and Clinical Data and Labeling for Breast Prostheses," which combines three previous guidances on silicone gel-filled, silicone inflatable (saline), and alternative breast implants are due by Jan. 3, 2000, several weeks after the agency's Nov. 17 deadline for saline breast implant PMAs
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