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Birth control apps show the contradictions in FDA device oversight

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The FDA says two types of digital birth control are the same, but one company disagrees

Digital birth control company Natural Cycles wasn’t happy with the news that the Food and Drug Administration cleared a second birth control app at the start of the month. The company, which was the first to get sign-off from the agency, says it’s glad to have the competition — but it takes issue with the way the FDA gave the new app, made by Clue, the okay.

The FDA can allow products to be sold and marketed in the US if they’re similar enough to something already available to consumers. In this case, the FDA is saying Clue is “substantially equivalent” to Natural Cycles — similar enough to earn the agency’s green light. But Natural Cycles doesn’t agree. “I feel this is slightly concerning,” Natural Cycles CEO Elina Berglund told The Verge .

These sorts of disagreements happen regularly in health care — usually in the back rooms of hospitals where companies jockey to sell their products to providers. For companies, touting the differences between physical medical devices, like surgical screws, infusion pumps, or heart monitors can make a difference in how much of their products […]

Click here to view original web page at www.theverge.com

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