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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR882.5975]
See Related Information on Human dura mater. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 882 -- NEUROLOGICAL DEVICES

Subpart F--Neurological Therapeutic Devices

Sec. 882.5975 Human dura mater.

(a)Identification. Human dura mater is human pachymeninx tissue intended to repair defects in human dura mater.

(b)Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled "Class II Special Controls Guidance Document: Human Dura Mater." See 882.1(e) for the availability of this guidance.

(c)Scope. The classification set forth in this section is only applicable to human dura mater recovered prior to May 25, 2005.

[68 FR 70436, Dec. 18, 2003, as amended at 76 FR 36993, June 24, 2011]

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