This article was originally published in The Gray Sheet
FDA tells Quidel that it must submit a premarket approval application for its SafePlan fertility awareness test, which measures hormone concentrations in urine to determine when a woman is in the "post-ovulatory, non-fertile phase" of her menstrual cycle and therefore "biologically unable to become pregnant," the firm explains. Quidel submitted a 510(k) for the product in October 1993; however, after reviewing the application, FDA concluded that SafePlan's "unique diagnostic measurement technology is not sufficiently similar to the predicate device" referenced in the 510(k), Quidel says
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