§310.502. Certain drugs accorded new drug status through rulemaking procedures. — Inbound Citations

(4) If the condition is initially determined not to be GRASE for OTC use in the United States, the agency will inform the sponsor and other interested persons who have submitted data of its determination by feedback letter, a copy of which will be placed on public display in the docket established in the Dockets Management Staff. The agency will publish a notice of proposed rulemaking to include the condition in § 310.502 of this chapter.

(ii) Include the condition in § 310.502 of this chapter.

(a) A contraceptive intrauterine device (IUD) is a device used to prevent pregnancy. The device is placed high in the uterine fundus with a string extending from the device through the cervical os into the vagina. This generic type of device includes the introducer, but does not include contraceptive IUD's that function by drug activity, which are subject to the new drug provisions of the Federal Food, Drug, and Cosmetic Act (see § 310.502).