CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES > SUBPART F—Obstetrical and Gynecological Therapeutic Devices (§884.5050 to §884.5970) > 884.5330—Female condom.

884.5330—Female condom.

(a) Identification. A female condom is a sheath-like device that lines the vaginal wall and is inserted into the vagina prior to the initiation of coitus. It is indicated for contraceptive and prophylactic (preventing the transmission of sexually transmitted diseases) purposes.
(b) Classification. Class III (premarket approval).
(c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. No effective date has been established of the requirement for premarket approval for the devices described in paragraph (b) of this section. See § 884.3 for effective dates of requirement for premarket approval.

Code of Federal Regulations

[65 FR 31455, May 18, 2000]