FDA: Rhythm Method App Can Be Marketed for Contraception | IUK Med Online
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FDA: Rhythm Method App Can Be Marketed for Contraception

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Medpage Today

FDA: Rhythm Method App Can Be Marketed for Contraception

Natural Cycles uses body temperature, menstrual cycle data to gauge daily fertility

MedpageToday

  • by Staff Writer, MedPage Today

WASHINGTON — Want to prevent pregnancy? There’s an FDA-approved app for that.

The rhythm method got a 21st century makeover when the FDA announced on Friday that they were permitting marketing of Natural Cycles, the first direct-to-consumer mobile medical application that can be used as “a method of contraception to prevent pregnancy” in premenopausal women ages ≥18.

Natural Cycles involves a woman inputting the reading of her waking basal body temperature, as well as her menstrual cycle information in the app, and the app then calculates days of the month where a woman is likely to be fertile, the agency said. Women who want to use the app “as a method of contraception” then avoid intercourse or use protection when “fertile day” is displayed on the app.

Clinical studies to evaluate the efficacy of Natural Cycles for “use in contraception” had 15,570 women use the app for an average of 8 months, and the agency cited a “perfect use” failure rate of 1.8%, meaning 1.8 in 100 women who used the app for 1 year would become pregnant because their protection failed on a fertile day or they had unprotected intercourse when the app “predicted they would not be fertile.” The app had a “typical use” failure rate of 6.5%, which accounted for “incorrect use,” such as having intercourse on fertile days.

Interestingly, a CDC fact sheet puts the failure rate of “fertility-based awareness” family planning methods at 24% (one assumes no data was available yet for fertility-based awareness method apps, however).

The agency said the application was approved under a de novo review pathway, and said they are establishing “special controls,” where the app meets criteria to assure “accuracy, reliability, and effectiveness” in preventing pregnancy. They added that this action also creates a new regulatory classification, with Natural Cycles serving as a so-called predicate device. That means similar apps putting the rhythm method into their own algorithms can reach market through the 510(k) process with no trials required, as long as they demonstrate “substantial equivalence” to Natural Cycles.

The FDA dutifully noted that the app does not provide protection against sexually transmitted infections.

2018-10-08T00:00:00-0400

last updated

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Medpage Today

FDA: Rhythm Method App Can Be Marketed for Contraception

Natural Cycles uses body temperature, menstrual cycle data to gauge daily fertility

MedpageToday

  • by Staff Writer, MedPage Today

WASHINGTON -- Want to prevent pregnancy? There's an FDA-approved app for that.

The rhythm method got a 21st century makeover when the FDA announced on Friday that they were permitting marketing of Natural Cycles, the first direct-to-consumer mobile medical application that can be used as "a method of contraception to prevent pregnancy" in premenopausal women ages ≥18.

Natural Cycles involves a woman inputting the reading of her waking basal body temperature, as well as her menstrual cycle information in the app, and the app then calculates days of the month where a woman is likely to be fertile, the agency said. Women who want to use the app "as a method of contraception" then avoid intercourse or use protection when "fertile day" is displayed on the app.

Clinical studies to evaluate the efficacy of Natural Cycles for "use in contraception" had 15,570 women use the app for an average of 8 months, and the agency cited a "perfect use" failure rate of 1.8%, meaning 1.8 in 100 women who used the app for 1 year would become pregnant because their protection failed on a fertile day or they had unprotected intercourse when the app "predicted they would not be fertile." The app had a "typical use" failure rate of 6.5%, which accounted for "incorrect use," such as having intercourse on fertile days.

Interestingly, a CDC fact sheet puts the failure rate of "fertility-based awareness" family planning methods at 24% (one assumes no data was available yet for fertility-based awareness method apps, however).

The agency said the application was approved under a de novo review pathway, and said they are establishing "special controls," where the app meets criteria to assure "accuracy, reliability, and effectiveness" in preventing pregnancy. They added that this action also creates a new regulatory classification, with Natural Cycles serving as a so-called predicate device. That means similar apps putting the rhythm method into their own algorithms can reach market through the 510(k) process with no trials required, as long as they demonstrate "substantial equivalence" to Natural Cycles.

The FDA dutifully noted that the app does not provide protection against sexually transmitted infections.

2018-10-08T00:00:00-0400

last updated

Comments

Accessibility Statement

At MedPage Today, we are committed to ensuring that individuals with disabilities can access all of the content offered by MedPage Today through our website and other properties. If you are having trouble accessing www.medpagetoday.com, MedPageToday's mobile apps, please email legal@ziffdavis.com for assistance. Please put "ADA Inquiry" in the subject line of your email.



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Dr Irfanullah Khan Born: 15th July,1994 in Khagram,Dir Upper KPK Pakistan. Others names:Doctor Irfo,Peshoo Education:Pharm-D Scholar Graduated from Abasyn University Peshawar. Occupation:Clinical Pharmacist,Doctor,Entrepreneur. Home Town:Dir Upper Height: 6 feet. Website:Iukmedonline.com

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