Medical Devices; Obstetrical and Gynecological Devices; Classification of the Hemorrhoid Prevention Pressure Wedge
fda-device · Food and Drug Administration · Rule · Published 2011-04-15 · Effective 2011-05-16 · 76 FR 21237
Document
Document number
2011-9141
Federal Register citation
76 FR 21237
CFR reference
21 CFR 884
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2011-04-15
Effective date
2011-05-16
HHS docket
Docket No. FDA-2011-N-0118
Abstract
The Food and Drug Administration (FDA) is classifying the hemorrhoid prevention pressure wedge into class II (special controls). The special controls will apply to the device in order to provide a reasonable assurance of safety and effectiveness of the device. A hemorrhoid prevention pressure wedge provides support to the perianal region during the labor and delivery process.