§ 876.5885. Tissue culture media for human ex vivo tissue and cell culture processing applications.
108 words·~1 min read·
/us/cfr/t21/s§ 876.5885·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]