TITLE 21 - FOOD AND DRUGS

CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 884 - OBSTETRICAL AND GYNECOLOGICAL DEVICES

subpart f - OBSTETRICAL AND GYNECOLOGICAL THERAPEUTIC DEVICES

884.5360 - Contraceptive intrauterine device (IUD) and introducer.

  (a) Identification. 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).

  (b) Classification. Class III (premarket approval).

  (c) Labeling. Labeling requirements for contraceptive IUD's are set forth in 801.427.

  (d) 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 August 4, 1986, for any IUD and introducer that was in commercial distribution before May 28, 1976, or that has on or before August 4, 1986, been found to be substantially equivalent to an IUD and introducer that was in commercial distribution before May 28, 1976. Any other IUD and introducer shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

[45 FR 1268412720, Feb. 26, 1980, as amended at 51 FR 16649, May 5, 1986]