Gastroenterology-Urology Devices; Classification for External Penile Rigidity Devices
fda-device · Food and Drug Administration · Rule · Published 2004-12-28 · Effective 2005-01-27 · 69 FR 77621
Document
Document number
04-28252
Federal Register citation
69 FR 77621
CFR reference
21 CFR 876
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2004-12-28
Effective date
2005-01-27
HHS docket
Docket No. 1998N-1111
Abstract
The Food and Drug Administration (FDA) is classifying external penile rigidity devices intended to create or maintain sufficient penile rigidity for sexual intercourse into class II (special controls). FDA also is exempting these devices from premarket notification requirements. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for the device.