Saline breast implant 510(k) requirements to be outlined in FDA letter to manufacturers.
This article was originally published in The Gray Sheet
Executive Summary
SALINE BREAST IMPLANT 510(K) CLEARANCE REQUIREMENTS will be spelled out by FDA in an upcoming letter to manufacturers that have expressed interest in pursuing premarket clearance of the devices, according to agency staffers. Expected to be sent in a few weeks, the letter will address pre- and postmarket study requirements for saline-filled breast implants.