21 CFR 876.5885 — Media, Culture, Ex Vivo, Tissue And Cell
Gastroenterology, Urology (GU) · Subpart F—Therapeutic Devices · § 876.5885
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.
Classification Rationale
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.”
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| NDS | Media, Culture, Ex Vivo, Tissue And Cell | 2 | 9 |
Special Controls
NDS — Media, Culture, Ex Vivo, Tissue And Cell
*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.”
eCFR
NDS — Media, Culture, Ex Vivo, Tissue And Cell
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.”
Ecfr Llm
