21 CFR § 876.5885 - Tissue culture media for human ex vivo tissue and cell culture processing applications.

---
identifier: "/us/cfr/t21/s876.5885"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 876.5885 - Tissue culture media for human ex vivo tissue and cell culture processing applications."
title_number: 21
title_name: "Food and Drugs"
section_number: "876.5885"
section_name: "Tissue culture media for human ex vivo tissue and cell culture processing applications."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "876"
part_name: "GASTROENTEROLOGY-UROLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "48 FR 53023, Nov. 23, 1983, unless otherwise noted."
cfr_part: "876"
---


# 876.5885 Tissue culture media for human ex vivo tissue and cell culture processing applications.

(a) *Identification.* Tissue culture media for human ex vivo tissue and cell culture processing applications consist of cell and tissue culture media and components that are composed of chemically defined components (e.g., amino acids, vitamins, inorganic salts) that are essential for the ex vivo development, survival, and maintenance of tissues and cells of human origin. The solutions are indicated for use in human ex vivo tissue and cell culture processing applications.

(b) *Classification.* Class II (special controls): FDA guidance document, “Class II Special Controls Guidance Document: Tissue Culture Media for Human Ex Vivo Processing Applications; Final Guidance for Industry and FDA Reviewers.”

[66 FR 27025, May 16, 2001]