What wording in the identification section of 21 CFR 884.5300(a) did the final rule change?
• FDA updated the term “venereal disease” to “sexually transmitted infection” which is a more accurate term used clinically. The identification section reads as follows: A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.
