This guidance document identifies the device description, preclinical, clinical, and labeling information we recommend you present in a premarket approval application (PMA) for a breast implant. This guidance document may also be useful in preparing an application for an investigational device exemption (IDE). This document addresses breast implants filled with saline, silicone gel, or alternative filler intended for breast augmentation or breast reconstruction. This guidance document does not address tissue expanders, which are reviewed under the premarket notification (510(k)) process.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.