Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh
Information
Type
Rule
Regulated products
Published
January 6, 2017
Last updated
January 6, 2017
Description
Document number 2016-31862. The Food and Drug Administration (FDA or the Agency) is reclassifying surgical instrumentation for use with urogynecologic surgical mesh from class I (general controls) exempt from premarket notification to class II (special controls) and subject to premarket notification, and identifying them as "specialized surgical instrumentation for use with urogynecologic surgical mesh." FDA is designating special controls that are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is reclassifying this device on its own initiative based on new information.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)