OBY · Class III — High Risk (PMA approval required, life-sustaining) · Obstetrics/Gynecology · 21 CFR 884.5330
Classification
FDA Product Code
OBY
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
21 CFR 884.5330
Review panel
OB
Medical specialty
Obstetrics/Gynecology
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
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.