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Kai
31 August 2014 @ 09:19 am
According to the FDA's website, cups are a Class II Medical Device with Performance Standards.

Cups Approved by the US FDA:
    = MeLuna Classic/Sport -- Jul 10, 2014
    = Femmycycle -- Nov 15, 2012
     = Sckoon -- Sep 18, 2012
    = Rhea -- May 24, 2012 (defunct brand?)
    = Bellecup -- Jun 28, 2010
    = Lunette -- Nov 13, 2009
    = Alicia -- Mar 05, 2008 (defunct brand)
    = (UK) Mooncup -- Dec 26, 2006
    = (US) Moon Cup -- Mar 30, 2005
    = Diva -- Jul 16, 2002
    = Instead Softcup -- Jun 06, 1997 and Oct 05, 1993 (two dates)
    = Keeper -- May 06, 1987
    = Tassaway -- Feb 12, 1981 (defunct brand)

To see the list for yourself, search for MENSTRUAL CUP at http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm

FDA Approval means that they are allowed to be sold by US retailers.  Americans can import non-FDA cups for their own personal use but may not sell them on a retail level.

Edited for clarity.
 
femininewearfemininewear on October 3rd, 2014 07:04 pm (UTC)
As far as I am aware Sckoon Cup only have approval for the clear cups, not the coloured ones. Also, Femmycycle just for the normal design but not the low cervix model.
Also, I think Lunette posted something about menstrual cups not needing FDA approval, it may have been on their facebook page
Kaikuradi8 on October 5th, 2014 07:45 pm (UTC)
If Sckoon's colors were not approved, they would not be able to sell them here to US customers. It's possible that the Femmycycle might have to get separate approval(s) for new models such as the Lite, the Low and the Teen because I don't think they were part of the original approval. And I think whoever at Lunette said that is mistaken or was taken out of context. Cups, tampons and pads are regulated by the FDA here in the US.
..::bella vita::..por_que_no on October 8th, 2014 05:16 pm (UTC)
I'm still wondering what happened to the Rhea and also the Bellecup (which I haven't found any info on except a mostly nonfunctional website)