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45 FR 12684, Feb. 26, 1980, unless otherwise noted.
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(a) Identification. A contraceptive tubal occlusion device (TOD) and introducer is a device designed to close a fallopian tube with a mechanical structure, e.g., a band or clip on the outside of the fallopian tube or a plug or valve on the inside. The devices are used to prevent pregnancy.
(b) Classification. Class III (premarket approval).
(c) Date premarket approval application (PMA) or notice of completion of a product development protocol (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 30, 1987, for any TOD and introducer that was in commercial distribution before May 28, 1976, or that has on or before December 30, 1987, been found to be substantially equivalent to a TOD and introducer that was in commercial distribution before May 28, 1976. Any other TOD and introducer shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
[45 FR 12684, Feb. 26, 1980, as amended at 52 FR 36883, Oct. 1, 1987]