eCFR Reference Browser

---

title: "21 CFR §882.5975"

source: "https://www.ecfr.gov/current/title-21/section-882.5975"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "882"

part_subject: "NEUROLOGICAL DEVICES"

subpart_code: "F"

subpart_subject: "Neurological Therapeutic Devices"

section_number: "882.5975"

section_subject: "Human dura mater."

cfr_reference: "21 CFR 882.5975"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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.

§882.5975 - Human dura mater.