GroundRules
21 CFR 882.5910: Dura substitute.
Where this section sits in the code
- 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
(a) Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).
(b) Classification. Class II (performance standards).
Collected 2026-08-27T02:24:47Z. Source file · JSON