{"id":5602,"date":"2016-11-02T09:19:04","date_gmt":"2016-11-02T15:19:04","guid":{"rendered":"http:\/\/admin.patheos.com\/blogs\/janetheactuary\/?p=5602"},"modified":"2016-11-02T09:19:04","modified_gmt":"2016-11-02T15:19:04","slug":"the-fda-lady-comp-and-a-few-questions","status":"publish","type":"post","link":"https:\/\/www.patheos.com\/blogs\/janetheactuary\/2016\/11\/the-fda-lady-comp-and-a-few-questions.html","title":{"rendered":"The FDA, Lady-Comp, and a few questions"},"content":{"rendered":"\n<\/head>

You\u2019ve perhaps read one of the stories about new apps for tracking your cycle for the purpose of avoiding conception. \u00a0The most popular of these seems to be\u00a0Kindara<\/a>, which\u00a0is an app that allows users to track their fertility signs, and is paired with an optional companion thermometer, the \u201cWink,\u201d that syncs with the app to simplify the process.<\/p>\n

Is Kindara FDA approved? \u00a0No, presumably because you don\u2019t need FDA approval for an app, any more than a book teaching natural family planning\/fertility awareness*, such as Taking Charge of Your Fertility<\/a>, requires approval. \u00a0What about the Wink? \u00a0There\u2019s a big disclaimer<\/a> on the site:<\/p>\n

Wink and Kindara are intended to help the user record and track basal temperatures, and are not intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.<\/p><\/blockquote>\n

(* Natural family planning and fertility awareness method are distinguished by, in the first case, abstaining, and in the second method, using a barrier method on unsafe days.)<\/p>\n

But there are other products, on the market in Europe as contraceptive devices*, that you won\u2019t find here:<\/p>\n

(*Yes, there\u2019s probably some legalese about what a contraceptive device is, but they market their ability to help the use not get pregnant, with a high degree of reliability, by identifying fertile days.)<\/p>\n

Lady-Comp is a device that tracks your BBT.<\/p>\n

Cyclo-Test does the same.<\/p>\n

Persona identifies safe days by using test strips. \u00a0Basically it\u2019s the ClearBlue Easy ovulation tester programmed differently.<\/p>\n

None of these have FDA approval. \u00a0In fact, in trying to find out more about the Lady-Comp, I came across three different complaint letters from the FDA, in 2010<\/a> to two individuals<\/a>, and another in 2013<\/a>, chock full of legalese, which seemed to be saying that the manufacturer did not follow the required extensive array of FDA \u201cmedical device\u201d requirements, but this was followed by another letter in 2014<\/a> saying that they had in fact remedied the FDA complaints. \u00a0But on the Lady-Comp site, they have the general disclaimer<\/a> that<\/p>\n

By completing this purchase you agree and understand that Lady-Comp \/ Lady-Comp baby will not protect against sexual transmitted diseases and that if used in the prescribed method will assure effectiveness of 99.3%. Lady-Comp is an FDA cleared Fertility Monitor and not FDA approved as a Contraceptive method or device.<\/p><\/blockquote>\n

Now, as it happens, Lady-Comp is actually available online in the U.S.<\/a>\u00a0 Not so for Cyclo-Test or Persona \u2014 you can look at these products at amazon.co.uk but there\u2019s a warning that they won\u2019t ship to the U.S. \u00a0 I don\u2019t know if it\u2019s because the former actually got clearance from the FDA, even if in the limited form of a generic \u201cfertility monitor\u201d without any family planning claims, or if there\u2019s some other reason.<\/p>\n

But none of these devices show up on any list of \u201cFDA approved contraceptive devices.\u201d<\/p>\n

And this matters.<\/p>\n

\u201cNot FDA approved\u201d is synonymous with \u201cunreliable,\u201d and keeps NFP\/FAM relegated to the list of \u201conly if you\u2019re crazy or stupid would you do this\u201d alongside \u201cthe pull-out method,\u201d even though many women don\u2019t want to dose their body with hormones for most of their adult lives \u2014 and, in the Obamacare world, it\u2019s the difference between paying out of pocket and getting your insurance to pay.<\/p>\n

And hence, here are the questions:<\/p>\n

I spent an inordinate amount of time trying to find the reasons why the FDA seemingly as policy does not approve any device for identifying safe days for NFP\/FAM, and came up empty, so I\u2019m asking readers if they have any knowledge that I don\u2019t.<\/p>\n

And, secondly, what do you think? \u00a0Should the FDA approve these devices, given that it acts as gatekeeper in multiple ways?<\/p>\n

\u00a0<\/p>\n<\/body><\/html>\n","protected":false},"excerpt":{"rendered":"

You\u2019ve perhaps read one of the stories about new apps for tracking your cycle for the purpose of avoiding conception. \u00a0The most popular of these seems to be\u00a0Kindara, which\u00a0is an app that allows users to track their fertility signs, and is paired with an optional companion thermometer, the \u201cWink,\u201d that syncs with the app to […]<\/p>\n","protected":false},"author":2209,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[269,489],"class_list":["post-5602","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-contraception","tag-nfp"],"yoast_head":"\nThe FDA, Lady-Comp, and a few questions<\/title>\n<meta name=\"description\" content=\"You've perhaps read one of the stories about new apps for tracking your cycle for the purpose of avoiding conception. \u00a0The most popular of these seems to\" \/>\n<meta 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