21 CFR 884.5050
§ 884.5050 Metreurynter-balloon abortion system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 884.5050, § 884.5050 Metreurynter-balloon abortion system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90839
- Permanent ID
ys:prov:90839@1- SHA-256
2399b70c7b70f22b8b60fcda1e7966055e43e700d3088d6947662802402b031b
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Full text
(a) Identification. A metreurynter-balloon abortion system is a device used to induce abortion. The device is inserted into the uterine cavity, inflated, and slowly extracted. The extraction of the balloon from the uterus causes dilation of the cervical os. This generic type of device may include pressure sources and pressure controls.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. A PMA or a 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 metreurynter-balloon abortion system 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 metreurynter-balloon abortion system that was in commercial distribution before May 28, 1976. Any other metreurynter-balloon abortion system 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.