All U.S. Condom Manufacturers, Importers and Repackagers
Published: 1987-04-07
Status: Final Type: Guidance Document Category: Premarket (510(k) / PMA / De Novo / IDE) Topics: Postmarket, Premarket Docket: FDA-2020-D-0957
Official Source
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/all-us-condom-manufacturers-importers-and-repackagers PDF: https://www.fda.gov/media/72176/download
Official Full Text
This guidance was written prior to the February 27, 1997 implementation of FDA's Good Guidance Practices, GGP's. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance will be updated m th n& revision to include the standard elernent s of GGP7s.
- . $5 ,- <\O %J
- . .'"r 7 0 6 q. Pubk Health Snvice DEPAltT.\l ENT OF HEALTH & H U A I A N SERVICES -
- . . Food and Omg Administration APR 71981: - . . Rockvilla MO 20857 To: A11 U.S. Condom Manufacturers, Importers and Repackagers . .
.
Because o f t h e heightened i n t e r e s t i n reducing t h e r i s k s o f a c q u i r i n g s e x u a l l y transmitted diseases (STOs), i n c l u d i n g Acquired Immune Oef i c i ency Syndrome (AIDS) , t h e Food and Drug Administration (FDA) i s p r d v i d i n g t h i s guidance t o manufacturers, importers and repackagers o f condoms. If designed, manufactured and t e s t e d properly, t h e condom i s a b a r r i e r t h a t may prevent the transmission o f STDs. With t h e spread o f STDs, i t has become very important t h a t users be f u l l y aware t h a t l a t e x condoms provide protection, b u t do n o t guarantee it, and t h a t p r o t e c t i o n i s l o s t i f condoms are n o t used properly. Given t h e urgent pub1 i c heal t h concerns regarding t h i s issue, FDA urges your cooperztion i n informing consumers about r e a l i s t i c expectations t h e y should have r-egardlng t h e p r o t e c t i o n afforded by condoms, and i n educating them about how condoms should be used t o maximize
- p r o t e c t i o n against IsT~~-;
I I F you are c u r r e n t l y marketing a l a t e x condom and wish t o claim t h a t d your product p r o v i e s p r o t e c t i o n against STDs , you should - j n c l ude appropriate l abel itig t h a t r e f 1 e c t s accurately t h e r e a l i s t i c expectations a condumer should have about t h e condom's effectiveness. An exarnpl e o f such l a b e l i n g appears i n Attachment A. Natural membranei day have a d i f f e r e n t p e r m e a b i l i t y than l a t e x and' may n o t l e n d themselves t o t h e same degree o f u n i f o n i t y i n manufacture as syn$hetic m a t e r i a l s such as l a t e x . I n t h e i n t e r e s t ' o f prudence, thereqore, FDA i s requesting t h a t you n o t label .natural membrane condoms fqr p r o t e c t i o n against STDs . I FDA is a1 so requesding t h a t a1 1 condoms, whether they are 1 abelled f o r p r o t e c t i o n zgailnst STOs o r n o t , and whether made from l a t e x , n a t u r a l membrane, r any other m a t e r i a l , i n c l u d k adequate . i n s t r u c t i o n s f o r u e t o maximize the degree o f p r o t e c t i o n they afford. An examp1 of such i n s t f u c t i o n s f o r use t o provide p r o t e c t i o n against STDs .appears i n Attachment 8. If YOU are currentljy marketing a condom you may change the l a b e l i n g . and i n s t r u c t i o n s fc/r%se o f Your product t o implement t h e guidance provided i n t h i s l q t t e r without seeking clearance from FDA. However, you must d b t a i n clearance from FDA i f you wish t o modify s i g n i f i c a n t l y your condom's design o r manufacturing, o r i f you wish t o use l a b e l i n g s i $ n i f i c a n t l y d i f f e r e n t Prom t h a t shown i n t h e d t tachments.. I For example, you will 1 need FDA clearance if you w i s h t o make claims t h a t your condom i s b e t t e r than o t h e r condoms o r t h a t i t i-s s p e c i f i c a l l y d e s i g d ,ed f o r A I D S . A l l new manufacturers o f condoms a r e a1 so r e q u i r e d tlo o b t a i n FDA clearance.
-. - 'Attachment A An acceptable statement of intended use for the prevention o f
- transmission of sexually transmitted diseases follows: .I ' "When used properly, the latex condom may prevent the transmission o f many sexually transmitted diseases (STDS) such as syphil i s , gonorrhea, chlamydia1 infections, genital herpes, and AIDS. It cannot eliminate the r i s k . For maximum piatection, i t i s important t o follow the accompanying instructions. Failure t o do so may r e s u l t . i n loss o f protection. Ouring intimate contact, lesions and various body fluids can transmit STDs. Therefore, the condom should be appl ied before any such contact ." Oifferent wording may be employed, but the wording should convey a balanced description of r i s k s and benefits, and there should be a warning about the loss o f protection r e s u l t i n g from improper. .use.
. - ' .-- '-ArEItceptabl e statement o f intended -use f o r prevention of I pregnancy could be similarly constructed, -