Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh
fda-device · Food and Drug Administration · Rule · Published 2017-01-06 · Effective 2017-01-06 · 82 FR 1598
Document
Document number
2016-31862
Federal Register citation
82 FR 1598
CFR reference
21 CFR 884
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2017-01-06
Effective date
2017-01-06
HHS docket
Docket No. FDA-2014-N-0297
Abstract
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.