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

Name: Saline, Silicone Gel, and Alternative Breast Implants: Guidance for Industry and FDA Staff
Creator: Food and Drug Administration
Keywords: breast-implants,fda,guidances,implants,industry,labeling,pre-market,pre-market-requirements,requirements

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Labeling, Premarket

Published

September 29, 2020

Last updated

September 28, 2020

Description

This document is a guidance for industry and FDA staff on labeling and premarket requirements for saline, silicone gel, and alternative breast implants.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

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1 Main file

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

Updated on September 28, 2020

pdf (452.0KB)

URL: https://www.fda.gov/media/71081/download
Permalink: https://data.openrid.co/en/datasets/r/a7f4654f-6257-4d0f-a3e3-6b0cba5cd21b
MIME Type: application/pdf

Created on: September 29, 2020
Modified on: September 28, 2020

Size: 452.0KB

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

Information

Type

Regulated products

Topics

Published

Last updated

Description

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