Medical Devices; Obstetrical and Gynecological Devices; Classification of the Assisted Reproduction Laser System
fda-device · Food and Drug Administration · Rule · Published 2004-12-28 · Effective 2005-01-27 · 69 FR 77623
Document
Document number
04-28251
Federal Register citation
69 FR 77623
CFR reference
21 CFR 884
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. 2004N-0530
Abstract
The Food and Drug Administration (FDA) is classifying the assisted reproduction laser system into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Assisted Reproduction Laser Systems." The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of the guidance document that is the special control for this device.