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

Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization - Guidance for Industry and Food and Drug Administration Staff

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