Medical Devices; Neurological Devices; Clarification of Classification for Human Dura Mater; Technical Amendment
fda-device · Food and Drug Administration · Rule · Published 2011-06-24 · Effective 2011-06-24 · 76 FR 36993
Document
Document number
2011-15817
Federal Register citation
76 FR 36993
CFR reference
21 CFR 882
Type
Rule
Action
Final rule; technical amendment.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2011-06-24
Effective date
2011-06-24
HHS docket
Docket No. FDA-1997-N-0040
Abstract
The Food and Drug Administration (FDA) is amending the device regulations to clarify the applicability of the device classification for human dura mater. This action is being taken to improve the accuracy of the regulations.