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GUIDANCE DOCUMENT

Saline, Silicone Gel, and Alternative Breast Implants Guidance for Industry and FDA Staff September 2020

Download the Final Guidance Document Read the Federal Register Notice
Final
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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Submit Comments Online

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

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

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

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