Quidel regulatory update

The FDA asked the San Diego company to file a PMA for the SafePlan fertility awareness product. The urine test measures hormone concentrations corresponding to the time when women are considered to be in the post-ovulatory, non-fertile phase of their monthly cycle.QDEL was planning to file a 510(k) on the product, but the agency said SafePlan's measurement technology is not sufficiently similar to the predicate device. ...