21 CFR 870.1360
§ 870.1360 Trace microsphere.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 870.1360, § 870.1360 Trace microsphere, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89893
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Full text
(a) Identification. A trace microsphere is a radioactively tagged nonbiodegradable particle that is intended to be injected into an artery or vein and trapped in the capillary bed for the purpose of studying blood flow within or to an organ.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any trace microsphere that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a trace microsphere that was in commercial distribution before May 28, 1976. Any other trace microsphere shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.