Docket Number:
FDA-2004-D-0124
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

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.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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Food and Drug Administration
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Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2004-D-0124.