21 C.F.R. § 882.5975 Human dura mater.
Title 21 - Food and Drugs
(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. [68 FR 70436, Dec. 18, 2003]
Title 21: Food and Drugs
PART 882—NEUROLOGICAL DEVICES
Subpart F—Neurological Therapeutic Devices
§ 882.5975 Human dura mater.
