New Guidance: Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization

["FDA Office of Women's Health" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: New Guidance: Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization

FDA Office of Women's Health

www.fda.gov/womens

Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization 

Today, the FDA has finalized the Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization guidance. This final guidance contains recommendations for the content and format of certain labeling components (a boxed warning and Patient Decision Checklist) that FDA intends to require for permanent hysteroscopically-placed tubal implants intended for sterilization, using Bayer’s Essure as an example.  

Read the Guidance

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FDA Office of Women’s Health

10903 New Hampshire Avenue

WO32 - Room 2333

Silver Spring, MD

20993-0002

301-796-9440

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