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

Issue Date: October 31, 2016
Issued by: Center for Devices and Radiological Health
Topic(s): Postmarket, Biostatistics, Adverse Event Reporting System (FAERS), 510(k), Adverse Event Reporting, Labeling, Gastroenterology-Urology
Status: Final

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

This guidance identifies the content and format for certain labeling components for permanent, hysteroscopically-placed tubal implant devices intended for female sterilization. FDA believes this guidance will help to ensure that a woman receives and understands information regarding the benefits and risks of this type of device prior to undergoing implantation. FDA’s guidance documents, including this guidance , do not establish legally enforceable responsibilities. Instead, guidances describe FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

Download the Guidance Document