21 CFR 864.2220
§ 864.2220 Synthetic cell and tissue culture media and components.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 864.2220, § 864.2220 Synthetic cell and tissue culture media and components, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89309
- Permanent ID
ys:prov:89309@1- SHA-256
ac32dbe5009bd8e1baf99b829d702f8ce1f5d573b53da70e54396258757148c5
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Full text
(a) Identification. Synthetic cell and tissue culture media and components are substances that are composed entirely of defined components (e.g., amino acids, vitamins, inorganic salts) that are essential for the survival and development of cell lines of humans and other animals. This does not include tissue culture media for human ex vivo tissue and cell culture processing applications as described in § 876.5885 of this chapter.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.