Neurological Devices; Classification of Human Dura Mater
other · Food and Drug Administration · Rule · Published 2003-12-18 · Effective 2004-01-20 · 68 FR 70435
Document
Document number
03-31174
Federal Register citation
68 FR 70435
CFR reference
21 CFR 882
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2003-12-18
Effective date
2004-01-20
HHS docket
Docket No. 2002N-0370
Abstract
The Food and Drug Administration (FDA) is classifying human dura mater intended to repair defects in human dura mater into class II (special controls). This action is being taken to establish sufficient regulatory control to provide reasonable assurance of the safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled "Class II Special Controls Guidance Document: Human Dura Mater" that will serve as the special control for this device.