CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 882—NEUROLOGICAL DEVICES > SUBPART F—Neurological Therapeutic Devices (§882.5030 to §882.5975) > 882.5975—Human dura mater.

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.

Code of Federal Regulations

[68 FR 70436, Dec. 18, 2003]